cloprostenol and Glaucoma--Open-Angle

The objective of this meta-analysis was to evaluate the effect of prostaglandin analogues (PGA) on central corneal thickness (CCT) in patients with glaucoma. Key electronic databases were searched for randomized controlled trials (RCTs) involving the CCT effects of prostaglandin use for glaucoma. Primary outcome measures were the mean difference in the CCT measurement from baseline to the last available assessment. Intraocular pressure and other corneal changes were recorded as secondary. Efficacy estimates were measured by their weighted mean difference (WMD) with 95% confidence intervals (CI's) by using the random-effects model for primary and secondary outcomes Trial sequential analysis was used to determine if the current evidence was sufficient and conclusive. Eight RCTs met our inclusion criteria. A total of 879 patients were included. The overall effect showed that PGA's had a significant CCT lowering effect (WMD = -7.04, 95%CI: -10.07 to -4.00, P < 0.00001). We pooled results of 5 RCT's on Travoprost (WMD = -10.44, 95%CI: -16.80 to -4.08, P = 0.001), seven trials on Latanoprost (WMD = -4.73, 95% CI: -9.70 to 0.25, P = 0.06), and three trials on Bimatoprost (WMD = -11.88, 95%CI: -21.03 to -2.73, P = 0.01). The WMD across groups in >6 months of PGA use was -11.37 (95%CI: -17.17 to -5.58, P = 0.0001), and in <6 months of PGAs group was -8.35 (95% CI: -12.01 to -4.69, P < 0.00001), suggesting a longitudinal effect of PGAs on CCT. In conclusion, Bimatoprost and Travoprost caused a statistically significant reduction in the thickness of central cornea. Though only a few studies were included, the narrow confidence intervals and adequate sample size suggest that these findings are valid.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Glaucoma, Open-Angle; Humans; Prostaglandins A; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

To systematically review the efficacy and tolerability of 4 prostaglandin analogues (PGAs) as first-line monotherapies for intraocular pressure (IOP) lowering in adult patients with primary open-angle glaucoma or ocular hypertension.. A literature search was performed in PubMed (1965-June 2013) and the Cochrane Library (1980-June 2013) using the search terms ocular hypertension, open-angle glaucoma, prostaglandin analogues, bimatoprost, latanoprost, tafluprost, and travoprost. Additional studies were searched from the reference lists of identified publications.. In all, 32 randomized controlled trials comparing between PGAs (bimatoprost 0.03%, latanoprost 0.005%, tafluprost 0.0015%, and travoprost 0.004%) or PGA with timolol were selected.. A network meta-analysis was conducted. Using timolol as reference, the relative risks (RRs) of achieving treatment success, defined as the proportion of patients achieving at least 30% IOP reduction, with 95% CIs, were as follows: bimatoprost, 1.59 (1.28-1.98); latanoprost, 1.32 (1.00-1.74); travoprost, 1.33 (1.03-1.72); and tafluprost, 1.10 (0.85-1.42). The mean IOP reductions after 1 month were 1.98 (1.50-2.47), 1.01 (0.55-1.46), 1.08 (0.59-1.57), and 0.46 (-0.41 to 1.33) mm Hg, respectively, and the results were sustained at 3 months. Bimatoprost was associated with the highest risk of developing hyperemia, whereas latanoprost had the lowest risk, with RRs (95% CI) of 4.66 (3.49-6.23) and 2.30 (1.76-3.00), respectively.. Bimatoprost achieved the highest efficacy in terms of IOP reduction, whereas latanoprost had the most favorable tolerability profile. This review serves to guide selection of the optimal PGA agent for individual patient care in clinical practice.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost

A new preservative-free fixed-dose combination of 0.0015% tafluprost, a prostaglandin F2α analog, and 0.5% timolol (TAF/TIM; Santen Oy, Tampere, Finland), a beta-adrenergic antagonist has recently been developed. The intraocular pressure (IOP) reduction with TAF/TIM in open-angle glaucoma and ocular hypertension is similar to that of other prostaglandin-timolol fixed-combination products. Patients with high IOP responded well to TAF/TIM with reductions of up to 40% (>13 mmHg) and beyond. Compared to previous controlled and double-masked clinical trials with DuoTrav(®) (Alcon, Fort Worth, USA) and Ganfort(®) (Allergan, Irvine, USA), TAF/TIM caused less superficial ocular side effects and less conjunctival hyperemia. Plausible explanations for the differences in side effects between the fixed-combination products are discussed.

Topics: Adrenergic beta-Antagonists; Amides; Cloprostenol; Double-Blind Method; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Randomized Controlled Trials as Topic; Timolol

many patients with glaucoma require multiple medications for adequate disease control. This review summarizes the efficacy and safety of the travoprost/timolol fixed combination in lowering intraocular pressure in eyes with glaucoma.. phase III and IV evaluations of travoprost/timolol are reviewed, including trials comparing the fixed combination with constituents, with unfixed concomitant therapy and with other unfixed and fixed combinations of glaucoma medications. The safety of travoprost/timolol is also reviewed.. the role of fixed-combination drugs, including travoprost/timolol, in the management of glaucoma is discussed. Unmet needs in glaucoma therapy, including long-acting drug delivery systems and therapies that treat glaucoma via mechanisms other than reduction of intraocular pressure, are also presented.

Topics: Animals; Antihypertensive Agents; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Timolol; Travoprost

Modern fixed-combination products simplify medication dose regimen without sacrificing their effectiveness.Potential benefits of the therapy with fixed-combination products are enhanced tolerability increased convenience,better compliance,cost and time economy and removal of the wash out effect. Regarding intraocular pressure lowering effect, fixed-combination agents are superior to monotherapy with the two medication components, with the exception of Duotrav that is not superior to travoprost action.Fixed-combination products are noninferior to concomitant administration of the two components of medication (nonfixed-combination agents) relative to their ocular hypotensive efficacy with the exception of Ganfort that is however inferior to concurrent administration of both the bimatoprost and timolol.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate, Timolol Maleate Drug Combination; Carbonic Anhydrase Inhibitors; Cloprostenol; Drug Combinations; Drug Therapy, Combination; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiazines; Thiophenes; Timolol; Travoprost; Treatment Outcome

To evaluate the intraocular pressure (IOP) reduction achieved by the most frequently prescribed antiglaucoma drugs in patients with normal tension glaucoma (NTG).. Systematic review and meta-analysis.. Fifteen randomized clinical trials reported 25 arms for peak IOP reduction, 16 arms for trough IOP reduction, and 13 arms for diurnal curve IOP reduction.. Pertinent publications were identified through systematic searches of PubMed, EMBASE, and the Cochrane Controlled Trials Register. The patients had to be diagnosed as having NTG. Methodological quality was assessed by the Delphi list on a scale from 0 to 18. The pooled 1-month IOP-lowering effects were calculated using the 2-step DerSimonian and Laird estimate method of the random effects model.. Absolute and relative reductions in IOP from baseline for peak and trough moments.. Quality scores of included studies were generally high, with a mean quality score of 12.7 (range, 9-16). Relative IOP reductions were peak, 15% (12%-18%), and trough, 18% (8%-27%) for timolol; peak, 14% (8%-19%), and trough, 12% (-7% to 31%) for dorzolamide; peak, 24% (17%-31%), and trough, 11% (7%-14%) for brimonidine; peak, 20% (17%-24%), and trough, 20% (18%-23%) for latanoprost; peak, 21% (16%-25%), and trough, 18% (14%-22%) for bimatoprost. The differences in absolute IOP reductions between prostaglandin analogues and timolol varied from 0.9 to 1.0 mmHg at peak and -0.1 to 0.2 mmHg at trough.. Latanoprost, bimatoprost, and timolol are the most effective IOP-lowering agents in patients with NTG.

Topics: Aged; Amides; Antihypertensive Agents; Betaxolol; Bimatoprost; Brimonidine Tartrate; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Quinoxalines; Randomized Controlled Trials as Topic; Sulfonamides; Thiazines; Thiophenes; Timolol; Tonometry, Ocular; Travoprost

Bimatoprost is a synthetic prostamide analog that is efficacious in the treatment of open-angle glaucoma, ocular hypertension and other forms of glaucoma. It reduces intraocular pressure (IOP) by increasing uveoscleral and trabecular outflow. When used as a 0.03% topical preparation once daily, it demonstrates sustained lowering of IOP of 7 - 8 mmHg over a 24-h period. The drug has been found to be more effective than timolol. In some studies it has shown greater ability to lower IOP when compared with other prostaglandin analogs; whereas in others all three clinically used prostaglandin analogs were found to be equally effective. It shows good IOP reduction when used in combination with other glaucoma medications. A common side effect includes mild conjunctival hyperemia, which is generally reversible. Other side effects include periorbital pigmentation, discomfort, ocular surface hyperemia and skin changes. Pharmacoeconomic data indicate that bimatoprost is cost effective in the treatment of open-angle glaucoma.

Topics: Amides; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure

Bimatoprost is a neutral lipid, a fatty acid amide that pharmacologically acts in both its paternal amide form and through its hydrolysis product (active free fatty acid of bimatoprost). Hypotensive ocular efficacy of bimatoprost is significantly superior to that of timolol and latanoprost. Mean ocular pressure decreases as well as percentages of reaching and sustaining the low targeting ocular pressures are higher comparing with travoprost. Conjunctival hyperemia produced by bimatoprost is statistically greater than that caused by timolol, latanoprost and travoprost; nevertheless it is well tolerated and mild in severity. Bimatoprost prostamide lowers ocular tension significantly and clinically relevant in patients uncontrolled with latanoprost; that is why bimatoprost can be used as additive or replacement therapy in patients who already receive maximal tolerated dose of latanoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Evidence-Based Medicine; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost; Treatment Outcome

Bimatoprost (Lumigan) is a synthetic prostamide that reduces intraocular pressure (IOP) by increasing the outflow of aqueous humour. In patients with open-angle glaucoma or ocular hypertension, long-term treatment (for up to 48 months) with once-daily bimatoprost 0.03% ophthalmic solution was more effective than timolol twice daily in providing a sustained and stable reduction in IOP. Bimatoprost 0.03% ophthalmic solution demonstrated efficacy similar to, or greater than, the prostaglandin analogues latanoprost and travoprost in reducing IOP and achieving target IOP levels. Switching to bimatoprost was as effective in maintaining diurnal IOP control as switching to a fixed combination of latanoprost/timolol (in patients with IOP levels controlled with a nonfixed combination of latanoprost plus timolol), and similarly, or more, effective in lowering IOP and providing overall diurnal IOP control than switching to a combination of dorzolamide/timolol (in patients with IOP inadequately controlled with other antiglaucoma agents including timolol). Treatment with bimatoprost was generally well tolerated, with conjunctival hyperaemia (mostly mild), growth of eyelashes and ocular pruritus being commonly reported. Other adverse events included increases in the pigmentation of the iris, perorbital areas and eyelashes.

Topics: Amides; Aqueous Humor; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Ocular Hypertension

Topics: Administration, Topical; Aged; Amides; Bimatoprost; Cloprostenol; Cysts; Dinoprost; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Iris Diseases; Latanoprost; Pigment Epithelium of Eye; Prostaglandins F, Synthetic; Recurrence; Retreatment

This systematic meta-analysis was performed to evaluate the intraocular pressure (IOP) lowering effects and tolerability of latanoprost, bimatoprost, and travoprost.. Clinical trials published up to July 2006 were thoroughly searched using all available databases and resources. The inclusion criteria were prospective randomized controlled clinical trials; patients with primary open-angle glaucoma or ocular hypertension; and prostaglandin monotherapy, without systemic/ocular medications or laser/surgery that could affect IOP within the past 3 months. Study quality was assessed with the Jadad scoring system, and potential bias was eliminated by robust statistical and independent reviews of publications. The main outcome measures were efficacy assessed by IOP (taken at 8 AM, noon, 4 PM, and 8 PM) change at 3 months from baseline and tolerability assessed by the incidence of conjunctival hyperemia.. Eight trials were identified (n=1610 patients). IOP change from baseline was statistically significantly greatest with bimatoprost, compared with latanoprost at all time points [weighted mean (WM) 8 AM: WM=0.50 mm Hg; P=0.05; 95% confidence intervals (CIs) 0.01-0.99; noon: WM=1.17 mm Hg; P<0.001; 95% CI 0.68-1.66; 4 PM: WM=0.78 mm Hg; P=0.003; 95% CI 0.26-1.29; 8 PM: WM=0.67 mm Hg; P=0.04; 95% CI 0.02-1.32], and with travoprost during the daytime (8 AM: WM=1.02 mm Hg; P=0.004; 95% CI 0.32-1.72; noon: WM=0.86 mm Hg; P=0.02; 95% CI 0.12-1.59). Latanoprost and travoprost were comparable in their ability to reduce IOP at all time points (P

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost; Treatment Outcome; Visual Fields

To evaluate efficacy and safety data of currently available ocular hypotensive medicines derived from 24-hour studies, of similar design, in patients with primary open-angle glaucoma (POAG), exfoliative glaucoma, or ocular hypertension (OH).. Meta-analysis of published articles evaluating patients with POAG, exfoliative glaucoma, or OH.. We included articles that were randomized, prospective, single- or double-masked, comparative studies of ocular hypotensive therapies over 24 hours. Each article selected contained an untreated baseline, >or=4-week treatment period, >/=20 patients per treatment arm, and >or=6 time points not spaced >5 hours apart and used Goldmann applanation or Tonopen tonometry (supine measurements) to measure intraocular pressure (IOP).. Twenty-four-hour IOP efficacy.. This analysis included 864 separate 24-hour treatment curves from 386 patients in 28 treatment arms from 11 studies. A statistical difference in the mean diurnal pressure decrease existed between monotherapy treatments for POAG/OH patients, with bimatoprost (29%) and travoprost (27%) showing the greatest 24-hour reduction (P = 0.026). Timolol 0.5% was less effective than latanoprost (24% vs. 19% reduction) but decreased the pressure at each night time point (P = 0.0003). Dorzolamide showed a 19% 24-hour pressure reduction and brimonidine 0.2% a 14% one. In exfoliative glaucoma patients, latanoprost and travoprost showed higher baseline and treatment pressures, although the pressure reductions (29% and 31%, respectively) were greater generally than observed with POAG/OH. An evening-dosed latanoprost/timolol fixed combination reduced the pressure 33%, and the dorzolamide/timolol fixed combination (DTFC), 26%. However, the power to detect a difference for this specific comparison was probably low, due to the limited number of patients (n = 20) in the DTFC group. A statistical difference between evening-dosed (24%) and morning-dosed (18%) latanoprost (P<0.0001) was noted, but not between evening (27%) and morning (26%) travoprost (P = 0.074). The mean reduction of night time points was statistically lower than day time points for latanoprost (P = 0.031), timolol (P = 0.032), and brimonidine (P = 0.050), but not for dorzolamide. Dorzolamide (P = 0.60), travoprost (P = 0.064), and bimatoprost (P = 0.057) did not demonstrate nighttime pressures lower than daytime ones. The mean reduction of night time points was statistically lower than that of day time points for latanoprost (P = 0.031), timolol (P = 0.032), and brimonidine (P = 0.050), but not for dorzolamide (P = 0.60), bimatoprost (P = 0.057), travoprost (P = 0.064).. Similar relative efficacies generally exist in various classes of ocular hypotensive agents during night and day hours.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Exfoliation Syndrome; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Single-Blind Method; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

Travoprost and timolol are topical ocular hypotensive medications that have been used in the treatment of glaucoma. The fixed combination eye drop, Duotrav (travoprost 0.004% and timolol maleate 0.5%), has recently been introduced into the market.. In this paper, the results of clinical trials and existing data on the performance of travoprost/timolol are discussed and analyzed.. Appopriate studies for review were identified using PubMed. Studies selected for review compared efficacy and side-effect profile of fixed combination travoprost/timolol with travoprost and timolol used concomitantly, latanoprost and timolol used concomitantly, fixed combination latanoprost/timolol, travoprost alone and timolol alone.. Fixed combination eye drops such as travoprost/timolol offer the potential benefits of increased patient adherence, reduced exposure to preservatives, and reduced cost.

Topics: Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Ocular Hypertension; Patient Compliance; Timolol; Travoprost

Fixed-combination travoprost/timolol solution consists of travoprost 0.004% and timolol 0.5%. Several studies have demonstrated the efficacy and safety of this medication used once daily for the treatment of open-angle glaucoma and ocular hypertension. This fixed combination has been compared to travoprost and timolol used concomitantly, latanoprost and timolol used concomitantly, latanoprost/timolol fixed combination and travoprost and timolol monotherapy. Fixed-combination medicines such as travoprost/timolol offer the potential of maximizing patient adherence by decreasing the burden of using multiple topical agents that lower intraocular pressure, and by potentially decreasing the overall cost to both the patient and the health-care system. We discuss the benefits of fixed-dose medications, report on previous clinical trials and summarize the existing data on the performance of travoprost/timolol.

Topics: Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Ocular Hypertension; Timolol; Travoprost

Bimatoprost (Lumigan) is a prostamide analogue used for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. In comparative clinical trials of up to 1 year in duration, administration of 0.03% bimatoprost ophthalmic solution once daily was more effective than 0.5% timolol twice daily and at least as effective as the prostaglandin analogues 0.005% latanoprost and 0.004% travoprost once daily in terms of reducing IOP and/or achieving target IOP levels. Bimatoprost was also more effective than twice-daily administration of 0.5%/2% timolol/dorzolamide in patients refractory to topical timolol therapy. Although generally well tolerated, bimatoprost is associated with a higher incidence of conjunctival hyperaemia than latanoprost, timolol or the combination of timolol and dorzolamide. Three fully published modelled cost-effectiveness analyses of bimatoprost evaluating cost per treatment success in patients with glaucoma or ocular hypertension have been conducted in the US. The analyses incorporated results of randomised, multicentre clinical trials and used a 1-year time horizon. In the treatment algorithm used in the models, patients not achieving target IOP levels with bimatoprost or comparator required additional medical visits and adjunctive therapy. Bimatoprost was associated with lower costs per treatment success than latanoprost, timolol or timolol/dorzolamide across a range of clinically relevant target IOPs. Results were sensitive to changes in treatment success rates and/or drug acquisition costs. Along with the inherent limitations of economic models, other possible criticisms of the analyses are the use of selected IOP data, and the lack of inclusion of costs associated with conjunctival hyperaemia or other adverse effects of therapy. Various other cost-effectiveness analyses of bimatoprost are available, primarily as abstracts and/or posters. In general, most of these studies have also been favourable for bimatoprost, despite having been conducted in different countries and/or from different perspectives. In conclusion, in patients with open-angle glaucoma or ocular hypertension, bimatoprost is an effective and generally well tolerated therapeutic option, albeit with a relatively high incidence of conjunctival hyperaemia. Although results of modelled cost-effectiveness analyses should be interpreted with due consideration of the limitations of the studies, available pharmacoeconomic data

Topics: Amides; Animals; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Lipids; Ocular Hypertension

It is still uncertain whether travoprost has comparable or better efficacy compared with other prostaglandin analogues or timolol in patients with open-angle glaucoma or ocular hypertension. The authors performed a meta-analysis of randomized controlled trials to evaluate the incidence of reported side-effects and intraocular pressure (IOP)-lowering effect of travoprost versus other prostaglandin analogues (latanaprost, bimatoprost, unoprostone) or timolol.. Systematic literature retrieval was conducted in Pubmed, EMBASE, Chinese Bio-medicine Database and Cochrane Controlled Trials Register to identify the potentially relevant randomized controlled trials. The statistical analysis was performed by RevMan 4.1 software that was provided by the Cochrane Collaboration. The outcome measures were the incidence of reported side-effects (hyperaemia, iris pigmentation, eyelash changes) and mean IOP pooled over treatment visits.. In total, 12 articles involving 3048 patients with open-angle glaucoma or ocular hypertension were included in this meta-analysis. The combined results showed that travoprost 0.004% was more effective than timolol or travoprost 0.0015% in lowering IOP, but not more effective than bimatoprost or latanoprost. Travoprost 0.004% caused a higher percentage of hyperaemia than timolol, latanoprost, or travoprost 0.0015%. There was an increased incidence of pigmentation with travoprost than timolol. Travoprost 0.004% caused a higher percentage of eyelash changes than timolol, latanoprost, or travoprost 0.0015%.. According to data available, travoprost is more effective than timolol in lowering IOP in patients with open-angle glaucoma or ocular hypertension. Compared with other prostaglandin analogues, travoprost appears to be equivalent to bimatoprost and latanoprost. Although a limited number of local side-effects were reported, no serious treatment-related side-effects were reported.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost

In the article the recent research on the biology of corneal stroma and biological impact of topical prostaglandin analogues on this tissue, were presented. The outcome of some studies, regarding influence of this class of antiglaucoma medication on central corneal thickness (CCT), were included. The impact of CCT on the readings of intraocular pressure and the aspect of diurnal fluctuations of CCT were also emphasized.

Topics: Administration, Topical; Cloprostenol; Cornea; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost

The objective of this review was to evaluate different measures of efficacy of the intraocular pressure (IOP) lowering lipid class agents bimatoprost, latanoprost and travoprost in the treatment of primary open angle glaucoma. Study arms of timolol in trials including the above mentioned lipid class drugs were also included.. MEDLINE and EMBASE were searched for randomized clinical trials including one or more of the lipid class drugs bimatoprost, latanoprost and travoprost. The study results were pooled, and the simple, weighted IOP-lowering efficacy was compared among the lipid class drugs and timolol, where data were available. Efficacy parameters were reviewed, including mean reduction of IOP and percentage of patients achieving different levels of IOP.. 161 articles were identified of which 42 were included in the analysis. A total of 9295 patients participated in the included trials. Based on all studies, timolol on average had a weighted mean IOP reduction of 22.2%, while latanoprost, travoprost and bimatoprost had a weighted mean IOP reduction of 26.7%, 28.7% and 30.3%, respectively. Analysis of target achievement to various IOP levels shows that bimatoprost seems more efficacious than latanoprost. The direct comparisons (head-to-head studies) also show that bimatoprost is the most efficacious treatment, however it is not conclusive whether latanoprost or travoprost is better in reducing IOP.. This review shows that bimatoprost seems to be the most efficacious treatment in lowering IOP. Head-to-head studies confirm this.

Topics: Adrenergic beta-Antagonists; Adult; Amides; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost; Treatment Outcome

When we reviewed the management of open-angle glaucoma in 1997, the topical drug treatments available included beta-blockers, a carbonic anhydrase inhibitor (dorzolamide), an alpha 2 agonist (apraclonidine), a prostaglandin analogue (latanoprost) and a variety of miotics and sympathomimetics. We concluded that a beta-blocker was the treatment of first choice. Here, we review seven new topical preparations that have been marketed, or had their licensed indications changed, since our earlier article.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Cloprostenol; Glaucoma, Open-Angle; Humans; Latanoprost; Lipids; Ophthalmic Solutions; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiazines; Travoprost

Travoprost is a synthetic ester prodrug of a prostaglandin F(2alpha) analogue used in the treatment of open-angle glaucoma and ocular hypertension. Intraocular travoprost 0.004% once daily was significantly more effective at reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension than placebo or timolol 0.5% twice daily and was at least as effective as latanoprost 0.005% once daily in randomised, double-blind studies. When used as adjunctive therapy with timolol 0.5% twice daily in patients with elevated IOP not adequately controlled by timolol alone, travoprost 0.004% showed significant additional IOP reduction in a randomised double-blind trial. Travoprost 0.004% was well tolerated in clinical trials. The majority of adverse events such as ocular hyperaemia and eyelash changes were mild and resolved without treatment.

Topics: Adult; Aged; Cloprostenol; Drug Administration Schedule; Glaucoma, Open-Angle; Half-Life; Humans; Intraocular Pressure; Ocular Hypertension; Randomized Controlled Trials as Topic; Travoprost

Normal-tension glaucoma was previously thought to be pressure insensitive, as medical treatment hardly reduced intraocular pressure and it did not prevent visual field loss. In the last decade, however, evidence has shown that the treatment of normal-tension glaucoma by lowering intraocular pressure can slow the deterioration of visual fields, hence the glaucomatous process. It was shown that a reduction of IOP of at least 30% is needed to induce a favorable alteration in the course of normal-tension glaucoma. New agents, such as prostaglandin analogs, the alpha(2)-adrenoceptor agonist brimonidine, and carbonic anhydrase inhibitors, have become available and may be of use in the treatment of normal-tension glaucoma. Monotherapy with prostaglandin analogs may meet the target of a reduction of IOP with 30%, but combination therapy will be needed in many cases. Few studies have been performed with brimonidine, travoprost, and bimatoprost, and it is suggested that more attention should be given to studies with these agents, as about 30% of patients with open angles and glaucomatous visual field defects have normal-tension glaucoma. Although neuroprotection is the goal of the future, no hard data are available yet which demonstrate that treatment with these agents will indeed result in preservation of visual fields.

Topics: Adrenergic alpha-Agonists; Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Carbonic Anhydrase Inhibitors; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Travoprost

Bimatoprost, a prostamide, effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. In clinical trials, bimatoprost has demonstrated superiority to the beta-adrenergic antagonist timolol and has consistently provided approximately 1-2 mmHg greater mean IOP lowering than the prostaglandin latanoprost. Bimatoprost is more effective than either timolol or latanoprost in allowing patients to reach the low target pressures that best protect the visual field. Patients on bimatoprost therapy achieve low pressures throughout the day and night. Moreover, 1-year trials have shown that the efficacy of bimatoprost is sustained with long-term use. The most common side effects have been conjunctival hyperaemia, graded as trace or mild, and eyelash growth. No safety concerns have arisen in postmarketing surveillance. Bimatoprost appears to be a valuable new agent for glaucoma therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amides; Antihypertensive Agents; Benzimidazoles; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Omeprazole; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes

To review available data related to the use of prostaglandin analogs (bimatoprost, latanoprost, travoprost, unoprostone) in the management of ocular hypertension and open-angle glaucoma.. Primary and review articles were identified from a MEDLINE search (1966-May 2001) and requested information from product manufacturers.. All available information, including that published in articles and abstracts, which was deemed relevant was included in this review. Limited data have been published to date.. The prostaglandin analogs appear to be effective, well-tolerated agents for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma and ocular hypertension. This drug class offers an alternative for patients who do not achieve control with another topical antiglaucoma agent or for those with a contraindication to first-line therapy with beta-adrenergic antagonists. Based on preliminary clinical data, bimatoprost, latanoprost, and travoprost appear to be at least as effective as timolol, while the effectiveness of unoprostone is similar or slightly less. Prostaglandin analogs may be used in conjunction with other antiglaucoma medications, although further studies must establish the optimal combination. Whether clinical experience will yield outcomes in favor of one of the prostaglandin analogs remains to be determined. Patients should be educated on adverse events associated with prostaglandin analogs, particularly the potential for changes in the pigmentation of the iris and eyelashes.. Bimatoprost, latanoprost, and travoprost appear to be equivalent to the current standard of therapy in the topical treatment of elevated IOP. Further clinical data published in article versus abstract format is required to better assess potential differences among these 3 agents.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Drug Storage; Glaucoma, Open-Angle; Humans; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

Bimatoprost, a synthetic prostamide analogue, is a new ocular hypotensive agent indicated for the second-line treatment of open-angle glaucoma and ocular hypertension. The drug is formulated as a 0.03% ophthalmic solution. Bimatoprost lowers intraocular pressure (IOP) by increasing aqueous humour outflow. When applied topically once daily in patients with ocular hypertension or glaucoma, bimatoprost 0.03% significantly reduced IOP. Mean IOP was reduced by approximately 7.5 to 9.2mm Hg 12 hours after drug administration in randomised clinical trials. The reduction in IOP was maintained throughout the 24-hour dosage interval. Once-daily treatment with bimatoprost 0.03% was found to be significantly more effective than timolol 0.5% (administered twice daily as an ophthalmic solution or once daily as a gel-forming solution) in randomised comparative trials in patients with ocular hypertension and glaucoma. Furthermore, after 1 to 6 months' treatment, the percentage of patients reaching a target IOP of < or =17mm Hg was significantly greater in the bimatoprost-treated groups than in those receiving timolol. Bimatoprost 0.03% ophthalmic solution was found to be at least as effective as topical latanoprost 0.005% administered once daily in two clinical trials. Reductions in IOP 16 and 20 hours postdose were greater in patients treated with bimatoprost, indicating superior control of IOP at timepoints throughout the dosage interval. In patients refractory to beta-blocker therapy, treatment with bimatoprost 0.03% produced greater reductions in diurnal IOP measurements than combination therapy with topical dorzolamide 2%/timolol 0.5%; approximately twice as many bimatoprost 0.03% recipients achieved an IOP of < or =16mm Hg. The most commonly reported adverse effect during clinical trials of once-daily bimatoprost 0.03% was conjunctival hyperaemia which occurred in 42 to 46% of patients treated. However, most cases were mild and only 1 to 4% of patients withdrew from treatment as a result. Overall withdrawal rates as a result of adverse events during clinical trials ranged from 2.6 to 7%. Bimatoprost has been reported to cause changes in the pigmentation of the periorbital skin, eyelashes and iris, and increase eyelash growth. The long-term consequences of these effects are unknown. Cardiopulmonary adverse effects, which have been associated with the use of beta-blockers such as timolol, were not reported in clinical trials of bimatoprost. Thus, in clinical trials o

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctival Diseases; Dose-Response Relationship, Drug; Drug Therapy, Combination; Glaucoma, Open-Angle; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Sulfonamides; Thiophenes; Timolol; Treatment Outcome

To compare the efficacies of latanoprost 0.005%, travoprost 0.004%, and tafluprost 0.0015% in reducing diurnal intraocular pressure (IOP) fluctuations in patients with newly diagnosed primary open-angle glaucoma (POAG).. In this prospective randomized clinical trial, 60 patients who were newly diagnosed with POAG were divided into three equal groups. Patients were examined at presentation and at second and sixth weeks. Diurnal phasing of IOP was conducted using a calibrated Goldmann applanation tonometer. IOP measurements were recorded from 8:00 am to 9:00 am, from 3:00 pm to 4:00 pm, and from 7:00 pm to 8:00 pm.. The study groups were distributed similarly in terms of age and gender (. Latanoprost, travoprost, and tafluprost show a similar effectiveness in reducing the mean IOP and the diurnal IOP fluctuation in POAG. Importantly, the three drugs have comparable tolerability with insignificant differences regarding the pattern of their side effects.

Topics: Adult; Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

To study the hypotensive effectiveness and safety of Bimoptic Plus (bimatoprost 0.03% + timolol 0.5%) in patients with developed primary open-angle glaucoma (POAG).. The study included 30 patients aged 57 to 72 years (45 eyes). The 1. The study was completed by 26 patients (41 eyes). Three patients (10%) has stopped using Bimoptic Plus due to side effects, one (3.3%) - due to insufficient hypotensive effect. In the 1. Bimoptic Plus effectively reduces the IOP level and has the least amount adverse reactions. It can be recommended for wide use in the treatment of patients with POAG.. Изучение гипотензивной эффективности и безопасности применения препарата «Бимоптик Плюс» (биматопрост 0,03% + тимолол 0,5%) у пациентов с развитой стадией первичной открытоугольной глаукомы (ПОУГ).. В исследование включены 30 пациентов в возрасте от 57 до 72 лет (45 глаз). В 1-ю группу вошли 15 пациентов (24 глаза), у которых впервые была диагностирована развитая глаукома с умеренно повышенным и высоким уровнем внутриглазного давления (ВГД) и препарат был назначен в качестве стартовой терапии. Больным 2-й группы (15 пациентов, 21 глаз) препарат «Бимоптик Плюс» был назначен при недостаточной эффективности монотерапии аналогами простагландинов. Период наблюдения составил 6 мес.. Исследование завершили 26 пациентов (41 глаз). Досрочно завершили участие в исследовании из-за развития побочных действий три пациента, из-за недостаточного гипотензивного эффекта — один. В 1-й группе максимальное снижение уровня ВГД было зафиксировано на 1-м месяце исследования и составило 8,34±1,47 мм рт.ст. (32,2%) от исходного. В сроки 2 нед, 3 и 6 мес данный показатель составил 8,1±1,52 мм рт.ст. (31,3%), 7,93±1,35 мм рт.ст. (30,6%) и 7,9±1,42 мм рт.ст. (30,5%) соответственно. У пациентов 2-й группы уровень дополнительного снижения офтальмотонуса в сроки 2 нед, 1, 3, 6 мес от начала лечения составил 4,68±1,24 мм рт.ст. (20,5%), 4,94±1,18 мм рт.ст. (21,7%), 4,55±1,23 мм рт.ст. (20%), 4,5±1,26 мм рт.ст. (19,7%) соответственно.. Эффективное снижение уровня ВГД на фоне применения препарата «Бимоптик Плюс» при хорошем показателе безопасности позволяет рекомендовать его для широкого применения в лечении пациентов с ПОУГ.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Middle Aged

To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003% with benzalkonium chloride-preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension.. Double-masked, randomized, 2-treatment, equivalence clinical trial.. setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe.. Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed.. Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003% (n = 442) or benzalkonium chloride-preserved travoprost 0.004% (n = 422) once daily for 3 months.. Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP <18 mm Hg or ≥30% IOP reduction, and adverse events.. Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5-18.9 mm Hg; travoprost 0.004% range, 17.4-19.0 mm Hg). Mean change (least squares mean differences, -0.1 to 0.3 mm Hg; 95% confidence interval, -0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%-30.7%; travoprost 0.004%, 28.5%-31.0%) from baseline were comparable. The percentages of patients with IOP <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%).. In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1-preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004%.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Polymers; Preservatives, Pharmaceutical; Retrospective Studies; Tonometry, Ocular; Travoprost; Treatment Outcome

The efficacy of lowering intraocular pressure (IOP) and safety of switching to travoprost/timolol fixed combination ophthalmic solution (Duotrav(®), Alcon Laboratories, Inc., Fort Worth, TX, USA) in patients with primary open-angle glaucoma, normal tension glaucoma or ocular hypertension undergoing prostaglandin analog (PGA) monotherapy was investigated.. Patients treated with travoprost, latanoprost, tafluprost, or bimatoprost for ≥3 months and requiring additional medication were switched to Duotrav without washout. Baseline IOP was calculated from measurements at two visits during PGA monotherapy. IOP reductions at 4, 8, and 12 weeks after switching to Duotrav and adverse events were assessed.. Of 162 patients enrolled, 157 patients (96.9%) with ≥4 weeks of follow-up after switching to Duotrav were analyzed. The mean IOP decreased significantly (baseline = 16.3 ± 3.1 mmHg; 4 weeks = 14.6 ± 3.1 mmHg, 8 weeks = 14.7 ± 3.3 mmHg, 12 weeks = 14.6 ± 3.2 mmHg; all P < 0.0001). When study eyes were divided into three groups according to baseline IOP (≥19 mmHg: 33 eyes, 21.0%; ≥15 to <19 mmHg: 78 eyes, 49.7%; <15 mmHg: 46 eyes, 29.3%), all groups showed significant IOP reductions (P = 0.0324 ~ P < 0.0001) after switching to Duotrav. Twenty-seven of 166 patients (16.3%) in the safety analysis experienced adverse events and 26/166 patients (15.7%) experienced adverse events, for which a relationship to Duotrav could not be ruled out. Adverse events in five patients led to treatment discontinuation (eye pruritus; eye irritation; increased blood pressure and rash; increased blurred vision; deepening of the eyelid sulcus and blepharoptosis). Twelve weeks after treatment switching, eyelash changes, blepharal pigmentation and deepening of the eyelid sulcus occurred in 42 (26.8%), 29 (18.5%), and 13 (8.3%) cases, respectively, among 157 patients with follow-up. There was no significant worsening from baseline for superficial punctate keratopathy (SPK) or conjunctival hyperemia after switching (SPK score: baseline = 0.58 ± 1.31; 12 weeks = 0.92 ± 1.76, P = 0.1819; conjunctival hyperemia score: baseline = 0.41 ± 0.64; 12 weeks = 0.49 ± 0.63, P = 0.3774).. Our findings confirm that switching to Duotrav(®) in PGA monotherapy patients shows IOP-lowering effect with minimal safety concerns.. Japan Association of Health Service and Alcon Japan. Ltd.. UMIN Clinical Trials Registry identifier, UMIN000007028.

Topics: Adult; Aged; Aged, 80 and over; Cloprostenol; Drug Combinations; Drug Substitution; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Japan; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Timolol; Tonometry, Ocular

To evaluate the effects of a bimatoprost/timolol fixed combination (BTFC) and a latanoprost/timolol fixed combination (LTFC) on diurnal intraocular pressure (IOP) and anterior ocular parameters in healthy subjects.. We enrolled 58 healthy subjects in this prospective clinical study. Thirty subjects were treated with BTFC and 28 subjects were treated with LTFC. IOP was measured every 2 hours except from 01:00 and 05:00. Axial length, corneal curvature, and anterior chamber depth were obtained using the IOL master at baseline and 24 hours later. Adverse events were assessed by patient interview and by slit lamp examination.. The largest difference in IOP between treated and untreated eyes 8 hours after instillation was 1.67 mmHg in the BTFC group (p < 0.001). The largest difference in IOP between treated and untreated eyes 10 hours after instillation was 1.93 mmHg in the LTFC group (p < 0.001). For anterior ocular parameters such as axial length, corneal curvature, anterior chamber depth at baseline and 24 hours after instillation, there were no significant differences between the baseline and 24-hour values in either the BTFC or LTFC group. The most frequently occurring adverse event was conjunctival hyperemia, which was found in 33.3% (n = 10) of the BTFC group and 25.0% (n = 7) of the LTFC group (p = 0.486).. BTFC and LTFC provided a significant reduction in IOP from baseline without changing any anterior ocular parameters. Our results provide a reference for monocular trials to assess the effect of eye drops in a clinical condition.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Follow-Up Studies; Glaucoma, Open-Angle; Healthy Volunteers; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Treatment Outcome

Lowering intraocular pressure (IOP) is currently the only therapeutic approach in primary open-angle glaucoma. and the fixed-combination medications are needed to achieve sufficiently low target IOP. A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China. In this study, we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension.. In this multicenter, randomized, double-masked, parallel controlled study, patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical β-blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1:1 ratio at 11 Chinese ophthalmic departments. Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03% bimatoprost and 0.5% timolol (followed by vehicle for masking) once daily at 19:00 P.M. and concurrent treatment was 0.03% bimatoprost followed by 0.5% timolol once daily at 19:00 P.M. The primary efficacy variable was change from baseline in mean diurnal intraocular pressure (IOP) at week 4 visit in the intent-to-treat (ITT) population. Primary analysis evaluated the non-inferiority of bimatoprost/ timolol fixed combination to concurrent with respect to the primary variable using a confidence interval (CI) approach. Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95% CI for the between-treatment (bimatoprost/timolol fixed combination minus concurrent) difference was ≤ 1.5 mmHg. Adverse events were collected and slit-lamp examinations were performed to assess safety. Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher's exact test.. Of the enrolled 235 patients, 121 patients were randomized to receive bimatoprost/timolol fixed combination and, 114 patients were randomized to receive concurrent treatment. At baseline the mean value of mean diurnal IOP was (25.20 ± 3.06) mmHg in the bimatoprost/timolol fixed combination group and (24.87 ± 3.88) mmHg in the concurrent group. The difference between the treatment groups was not statistically significant. The mean change from baseline in mean diurnal IOP (± standard deviation) in the bimatoprost/timolol fixed combination group was (-9.38 ± 4.66) mmHg and it was (-8.93 ± 4.25) mmHg in the concurrent group (P < 0.01). The difference between the two treatment groups (bimatoprost/timolol fixed combination minus concurrent) in the change from baseline of mean diurnal IOP was -0.556 mmHg (95% CI: -1.68, 0.57, P = 0.330). The upper limit of the 95% CI was less than 1.5 mmHg, the predefined margin of non-inferiority. Adverse events occurred in 26.4% (32/121) of the bimatoprost/timolol fixed combination patients and 30.7% (35/114) of the concurrent patients. The most frequent adverse event was conjunctival hyperemia, which was reported as treatment related in 16.5% (20/121) in the bimatoprost/timolol fixed combination group and 18.4% (21/114) in the concurrent group (P > 0.05).. Bimatoprost/Timolol Fixed Combination administered in Chinese patients with open-angle glaucoma or ocular hypertension was not inferior to concurrent dosing with the individual components. Safety profiles were similar between the treatment groups.

Topics: Adolescent; Adult; Aged; Amides; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Ocular Hypertension; Timolol; Young Adult

To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension.. In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population.. 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity.. Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability.. NCT01177098.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Therapeutic Equivalency; Timolol; Tonometry, Ocular; Treatment Outcome; Young Adult

Medications to control intraocular pressure (IOP) are frequently preserved using benzalkonium chloride (BAK), which can negatively affect the ocular surface. Data are needed to assess efficacy and safety of prostaglandin drugs preserved with and without BAK. The present study compared the efficacy and safety of BAK-free travoprost 0.004% (TRAV) and BAK 0.02%-preserved bimatoprost 0.01% (BIM) during late-day time points in patients with open-angle glaucoma or ocular hypertension.. This was a 12-week, phase 4, randomized, investigator-masked, crossover study. 84 patients with IOP ≥24 and <36 mmHg were randomized 1:1 to receive once-daily TRAV or BIM for 6 weeks followed by an additional 6-week crossover period. IOP was measured at the end of each treatment period at 4, 6, and 8 pm. TRAV was considered noninferior to BIM if the upper limit of the 95% CI of the between-group difference in mean IOP was ≤1.5 mmHg. Adverse events were assessed throughout the study.. One patient discontinued due to allergic conjunctivitis, and 2 patients with missing data were excluded; 81 patients were included in the per-protocol population (mean ± SD age, 58.3 ± 11.4 years; TRAV/BIM, n = 41; BIM/TRAV, n = 40). After 6 weeks, mean IOP with TRAV (17.4 ± 2.7 mmHg; change from baseline, -6.0 mmHg) was similar to BIM (17.2 ± 2.6 mmHg; change from baseline, -6.3 mmHg); the between-group difference was 0.22 mmHg (95% CI, -0.22 to 0.67). Thus, noninferiority of TRAV versus BIM was demonstrated. Mean IOP at each time point and mean and percentage IOP change from baseline were not significantly different between treatments. All treatment-emergent adverse events were mild to moderate. The incidences of mild ocular hyperemia with TRAV and BIM were 31% and 39%, respectively; moderate hyperemia was observed in 2% of patients receiving BIM.. Late-day IOP-lowering efficacy of BAK-free TRAV was noninferior to that of BAK 0.02%-preserved BIM; both reduced baseline IOP by 25%. Both treatments were well tolerated, although a higher incidence of moderate ocular hyperemia was observed with BIM.. ClinicalTrials.gov identifier, NCT01464424; registered November 1, 2011.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Benzalkonium Compounds; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Therapeutic Equivalency; Tonometry, Ocular; Travoprost

Fixed-combination ocular hypotensives have multiple advantages, but triple-therapy dorzolamide/brimonidine/timolol (dorz/brim/tim) is only available in Latin and South America, and information on its relative efficacy is limited. This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol (bim/tim) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension.. In this investigator-masked, crossover study, patients with unmet target intraocular pressure (IOP) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3 months before returning to their pre-baseline medication for 3 months. IOP was evaluated before and after morning instillation at months 2, 3, 5 and 6. Primary endpoints were mean IOP change and Ocular Surface Disease Index© (OSDI) score at each visit. The intent-to-treat population was the a priori analysis population, but due to the number of discontinuations, the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses, respectively.. Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations, respectively. At month 3, statistically significant IOP reductions from baseline were observed in the bim/tim (P < 0.01) and dorz/brim/tim (P < 0.0001) groups, regardless of assessment time. At month 6, patients returned to bim/tim exhibited no significant IOP increase (regardless of assessment time), but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase (P < 0.001) when assessed before instillation of study treatment. Results were similar in both intent-to-treat and per-protocol analysis populations. In the per-protocol analysis, 70% of patients on bim/tim at month 3 had an IOP <14 mm Hg, which declined to 58% (P = 0.0061) at month 6 (ie, after 3 months of dorz/brim/tim treatment). In patients receiving dorz/brim/tim at month 3, 38% had an IOP <14 mm Hg, which remained comparable after return to bim/tim. OSDI scores and incidence of adverse events were similar in both groups.. In this first direct comparison of the efficacy of dorz/brim/tim and bim/tim, patients switched from dorz/brim/tim to bim/tim demonstrated improved/lower IOP; when returned to dorz/brim/tim, IOP increased to levels seen at study initiation, suggesting that once-daily bim/tim may have greater IOP-lowering efficacy. Both bim/tim and dorz/brim/tim were well tolerated with minimal ocular surface damage.. ClinicalTrials.gov: NCT01737853 (registered October 9, 2012).

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Quinoxalines; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Treatment Outcome

This study evaluated the effects of acetazolamide, latanoprost, travoprost, bimatoprost, brimonidine, brinzolamide, and timolol on pain during phacoemulsification cataract surgery.. This prospective randomized comparative study included 323 eyes of 323 patients with no history of intraocular surgery or chronic eye disease who underwent uncomplicated phacoemulsification cataract surgery and foldable intraocular lens implantation under topical anesthesia. Patients were divided into 8 groups according to the preoperative prophylactic intraocular pressure (IOP)-lowering medication. The intraoperative pain was assessed postoperatively using a visual analog pain scale. The Kruskal-Wallis test investigated the differences in the visual analog pain-scale scores of the groups, and the Mann-Whitney U test investigated the pairwise comparison of the groups.. The median visual analog pain-scale score of the group that did not receive any IOP-lowering medication was 2.0±1.89. The brimonidine group exhibited the lowest visual analog pain-scale scores, and the prostanoids, especially the bimatoprost group, demonstrated the highest visual analog pain-scale scores (median±standard deviation were 0.0±1.50 and 2.0±1.91, respectively). The median visual analog pain-scale scores of the acetazolamide, latanoprost, travoprost, brinzolamide, and timolol groups were 0.0±1.62, 2.0±1.67, 2.0±1.73, 0.0±1.66, and 1.0±1.54, respectively. A pairwise comparison using the Mann-Whitney U test with Bonferroni correction revealed significant differences between the groups of acetozolamide and travoprost (p=0.001), acetozolamide and bimatoprost (p<0.001), travoprost and brimonidine (p<0.001), bimatoprost and brimonidine (p<0.001), and bimatoprost and timolol (p=0.001).. Prophylactic application of the IOP-lowering medication may alter the pain sensation during phacoemulsification cataract surgery.

Topics: Acetazolamide; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Cataract; Cloprostenol; Combined Modality Therapy; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Pain; Phacoemulsification; Postoperative Period; Prospective Studies; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiophenes; Timolol; Travoprost

There has been increased attention on the potential impact of the preservative benzalkonium chloride (BAK) on the ocular surface. This study compared the ocular surface tolerability of once-daily bimatoprost 0.01% and latanoprost 0.005% (both preserved with 0.02% BAK), and travoprost 0.004% preserved with sofZia™.. A randomized, multicenter (15 sites), investigator-masked study enrolled patients with open-angle glaucoma or ocular hypertension who had received latanoprost monotherapy for at least 1 month. Patients were randomized to oncedaily bimatoprost (n = 56), travoprost (n = 53), or latanoprost (n = 55) monotherapy for 3 months. Follow-up visits were at weeks 1, 4, and 12. The primary outcome measure was physician-graded conjunctival hyperemia (scale 0 to 3) at week 12. Secondary outcomes included corneal staining (scale 0 to 3) and tear break-up time (TBUT).. There were no significant differences in mean (standard deviation [SD]) outcome measures including conjunctival hyperemia (bimatoprost: 0.48 [0.52], travoprost: 0.49 [0.52], latanoprost: 0.51 [0.54]), corneal staining (bimatoprost: 0.31 [0.49], travoprost: 0.25 [0.46], latanoprost: 0.24 [0.45]), or TBUT (bimatoprost: 9.7 s [6.1], travoprost: 9.5 s [5.8], latanoprost: 9.8 s [5.0]) among subjects at latanoprost-treated baseline (P ≥ 0.664). At week 12, there were no significant differences in conjunctival hyperemia (bimatoprost: 0.42 [0.48], travoprost: 0.46 [0.44], latanoprost: 0.44 [0.57]), corneal staining (bimatoprost: 0.31 [0.45], travoprost: 0.32 [0.48], latanoprost: 0.22 [0.30]), or TBUT (bimatoprost: 9.7 s [5.7], travoprost 9.7 s [5.0], latanoprost: 9.3 s [4.0]) among the treatment groups (P ≥ 0.379). At week 1, there was a statistically significant among-group difference in mean change from baseline in hyperemia (+0.04, bimatoprost; +0.20, travoprost; 0.00, latanoprost; P = 0.018). There were no statistically significant among-group differences in mean corneal staining, mean TBUT, or change from baseline at any visit.. Despite preservative differences, there were no significant differences in objective clinical measures of ocular surface tolerability after 3 months of treatment with bimatoprost (with 0.02% BAK), travoprost (with sofZia), and latanoprost (with 0.02% BAK).

Topics: Aged; Amides; Benzalkonium Compounds; Bimatoprost; Cloprostenol; Conjunctival Diseases; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

To determine the adjunctive 24-h efficacy obtained with brinzolamide/timolol, or brimonidine/timolol fixed combinations (FCs) in open-angle glaucoma patients insufficiently controlled on travoprost monotherapy.. Prospective, observer-masked, active controlled, crossover, comparison. Qualified primary open-angle or exfoliative glaucoma patients with a baseline intraocular pressure (IOP) >18 mm Hg at 10:00 on travoprost monotherapy were randomized for 3 months to either brinzolamide/timolol, or brimonidine/timolol FC therapy adjunct to travoprost. Patients were then crossed-over to the opposite therapy for another 3 months. At baseline and at the end of each treatment period, the patients underwent 24-h IOP monitoring.. Fifty patients completed the study. The mean 24-h baseline IOP on travoprost monotherapy was 20.1 mm Hg [95% confidence interval (CI): 19.6, 20.7 mm Hg]. Both adjunctive FC therapies significantly reduced the IOP at each time point and for the mean 24-h IOP (P<0.001) compared with travoprost monotherapy. Brinzolamide/timolol FC provided a significantly lower mean 24-h IOP (17.2 mm Hg, 95% CI: 16.4, 17.9 mm Hg) than brimonidine/timolol FC (18.0 mm Hg, 95% CI: 17.3, 18.8 mm Hg) (P<0.001). For all the 3 timepoints between 18:00 and 02:00, the brinzolamide/timolol FC provided a significantly lower IOP than the brimonidine/timolol FC (P≤0.036). For the other 3 timepoints, no significant differences were detected.. This study demonstrated that both FCs provide statistically and clinically significant incremental 24-h IOP lowering to travoprost monotherapy. The brinzolamide/timolol FC however achieves a better mean 24-h IOP control owing to the greater efficacy in late afternoon and during the night.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Brimonidine Tartrate; Cloprostenol; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Prospective Studies; Quinoxalines; Sulfonamides; Thiophenes; Time Factors; Timolol; Travoprost

Primary open-angle glaucoma (POAG), a chronic, degenerative optic neuropathy, requires persistent decrease of intraocular pressure so as to prevent visual impairment and blindness. However, long-term use of topical ocular medications may affect ocular surface health. Purpose of this study was to evaluate the influence of BAK-preserved prostaglandin analog treatment on the ocular surface health in patients with newly diagnosed POAG.. 40 newly diagnosed POAG patients were included in this prospective study. Intraocular pressure (IOP), tear break-up time (TBUT), and ocular surface disease index (OSDI) were assessed at baseline and 3-month after starting treatment with BAK-preserved travoprost 0.004%.. IOP decreased in all patients from baseline to 3-month final visit (23.80 ± 1.73 mmHg versus 16.78 ± 1.27 mmHg; P < 0.001). Mean TBUT decreased from 11.70 ± 1.86 seconds at baseline to 8.30 ± 1.29 seconds at 3-month final visit (<0.001). Mean OSDI score increased from 31.63 ± 18.48 to 44.41 ± 16.48 (P < 0.001).. This study showed that BAK-preserved travoprost 0.004% is an effective medication in newly diagnosed POAG patients, but its long-term use may negatively influence ocular surface health by disrupting the tear film stability. Further studies are needed to better understand the clinical effects of different preservative types and concentrations on the ocular surface.

Topics: Adult; Aged; Antihypertensive Agents; Cloprostenol; Croatia; Dry Eye Syndromes; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Travoprost; Treatment Outcome

To compare the efficacy and safety of bimatoprost 0.01% with the fixed combination travoprost 0.004%/timolol 0.5% in subjects with stable intraocular pressure (IOP) control on latanoprost and timolol.. This was a randomized, prospective, investigator masked, crossover study comparing bimatoprost 0.01% with travoprost/timolol in 40 subjects diagnosed with primary open-angle glaucoma. Subjects were randomized to bimatoprost 0.01% qpm or travoprost/timolol qam and followed for 12 weeks, at which time they were crossed over to the alternate medication and followed for another 12 weeks. Intraocular pressure and hyperemia (rated on a standardized, 5-point photographic scale) were evaluated as change from baseline to 12 weeks following each therapy, and subject preference was elicited at the end of the study.. Both treatments were well tolerated and the majority of patients achieved effective IOP control relative to baseline. After 12 weeks of treatment, mean reductions from baseline IOP were -1.68 mmHg OD (right eye) and -1.58 mmHg OS (left eye) with bimatoprost and -0.45 mmHg OD and -0.53 mmHg OS with travoprost/timolol, although the differences between drugs were not statistically significant. Hyperemia scores were significantly higher with the fixed combination of travoprost/timolol than bimatoprost 0.01% as measured at 8 am (both P<0.01). Subject preference at the end of the study was more than 3 to 1 in favor of bimatoprost, with most citing greater tolerability.. Bimatoprost 0.01% and travoprost/timolol are both effective at reducing IOP in subjects with stable IOP control on latanoprost and timolol, but bimatoprost 0.01% is associated with less hyperemia.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Patient Preference; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Timolol; Travoprost; Treatment Outcome

To compare ocular surface changes induced via glaucoma treatment in patients using fixed combinations of prostaglandin analogues (travoprost, latanoprost and bimatoprost) with 0.5% timolol maleate. A prospective, multicenter, randomized, parallel group, single-blind clinical trial was performed in 33 patients with ocular hypertension or open angle glaucoma who had not been previously treated. The ocular surface was evaluated prior to and three months after treatment, with a daily drop instillation of one of the three medications. The main outcome measurements included the tear film break-up time, Schirmer's test, Lissamine green staining, the Ocular Surface Disease Index questionnaire, impression cytology using HE and PAS and immunocytochemistry for interleukin-6 and HLA-DR. Ensaiosclinicos.gov.br: UTN - U1111-1129-2872 RESULTS: All of the drugs induced a significant reduction in intraocular pressure. Decreases in the Schirmer's test results were observed with all of the drugs. Decreases in tear-film break-up time were noted with travoprost/timolol and latanoprost/timolol. An increase in the Lissamine green score was noted with travoprost/timolol and bimatoprost/timolol. The Ocular Surface Disease Index score increased after treatment in the travoprost/timolol group. Impression cytology revealed a significant difference in cell-to-cell contact in the same group, an increase in cellularity in all of the groups and an increase in the number of goblet cells in all of the groups. The fixed combinations induced an increase in IL-6 expression in the travoprost/timolol group, in which there was also an increase in HLA-DR expression.. All of the fixed combinations induced a significant reduction in intraocular pressure, and the travoprost/timolol group showed increased expression of the inflammatory markers HLA-DR and interleukin-6. All three tested medications resulted in some degree of deterioration in the ocular surface after three months of glaucoma treatment.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Eye; Female; Glaucoma, Open-Angle; HLA-DR Antigens; Humans; Immunohistochemistry; Interleukin-6; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Single-Blind Method; Timolol; Travoprost; Treatment Outcome

To investigate the clinical effects of travoprost-timolol fixed combination on ocular hypotensive agents, ocular surface agents and adherence in Japanese glaucoma patients.. 28 Japanese glaucoma patients, who had used topical prostaglandin F2alpha analogue (28 eyes; PG group), were assigned to treatment with travoprost-timolol fixed combination. Reduction of intraocular pressure (IOP), grades of conjuctival follicle, conjuctival injection and keratoepitheliopathy, as well as interviews for topical administration, were evaluated. 38 patients, who switched from the topical prostaglandin F2alpha analogue and a beta-blocker to travoprost-timolol fixed combination (38eyes: PG+BB group) were also evaluated in the same manner.. While IOP was significantly reduced in the PG group, IOP was not changed in the PG+BB group. Both groups showed no significant changes in scores for conjuctival follicle, keratoepitheliopathy, or interview.. These results suggest that travoprost-timolol fixed combination reduces IOP and produces low toxicity on the ocular surface.

Topics: Adrenergic beta-Antagonists; Aged; Antihypertensive Agents; Asian People; Cloprostenol; Cornea; Dinoprost; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Patient Satisfaction; Surveys and Questionnaires; Timolol; Travoprost; Treatment Outcome

To study the effect of patient education and the TravAlert(®) -Eyot(®) drop guider on intraocular pressure (IOP) and adherence in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) monitored with the TravAlert(®) dosing aid.. Multicentre, randomized, controlled clinical trial among 18 Dutch hospitals. Patients were randomized to one of the four study arms: (1) use of the dosing aid, (2) use of the dosing aid with the drop guider, (3) use of the dosing aid together with patient education or (4) use of the dosing aid and drop guider together with patient education. IOP was recorded at baseline and after 3 and 6 months. Data on adherence generated by the dosing aid were collected and studied at the end of the study.. Mean IOP dropped from 20.3 ± 5.7 mmHg at baseline to 16.3 ± 4.0 mmHg (right eye) after 6 months and from 20.2 ± 5.9 mmHg to 16.4 ± 4.1 mmHg (left eye). The mean adherence rate was 0.91 ± 0.1. IOP and adherence rate were not statistically different between the study arms. Patients with 'drug holidays' had a significantly higher mean IOP after 6 months. Patients who used the drop guider were less adherent. A lower adherence level was also associated with new patients with glaucoma and patients with a lower level of knowledge on glaucoma.. Patient education is especially useful for new patients with glaucoma. The use of a drop guider does not improve adherence. Especially patients with 'drug holidays' are at risk for developing uncontrolled IOP levels.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Combinations; Drug Monitoring; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Netherlands; Ocular Hypertension; Ophthalmic Solutions; Patient Compliance; Patient Education as Topic; Surveys and Questionnaires; Timolol; Tonometry, Ocular; Travoprost

To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost.. A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out.. Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction.. Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP.

Topics: Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Conjunctiva; Conjunctival Diseases; Cornea; Corneal Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Tonometry, Ocular; Travoprost; Treatment Outcome

To compare the efficacy of brinzolamide versus placebo when added to travoprost/timolol fixed combination (TTFC) in uncontrolled patients.. This was a prospective, double-masked, randomized, placebo-controlled, parallel comparison of ocular hypertensive or primary open-angle glaucoma patients. Patients treated with a prostaglandin-based mono or adjunctive therapy were changed to TTFC qam (every day dosing) for 4 weeks. Patients with an intraocular pressure (IOP) of 19 to 32 mm Hg at 08:00 hours underwent additional measurements at 12:00 and 16:00 hours. Patients were then randomized to either placebo or brinzolamide given twice daily in addition to TTFC. At week 12, patients had their IOP measurements repeated.. The per protocol dataset consisting of 78 placebo and 75 brinzolamide-treated patients decreased mean diurnal IOP (mm Hg) as well as IOP at all 3 individual time points (P≤0.005). Brinzolamide reduced the mean diurnal IOP from 20.3±2.0 to 17.5±2.6, whereas placebo reduced IOP from 20.9±2.7 to 19.4±3.8. The mean diurnal IOP was reduced from baseline and for the 08:00 and 16:00 hours time points in the brinzolamide group compared with placebo (P≤0.014). There were 30 adverse events with placebo and 24 with brinzolamide (intent-to-treat). There was no statistical difference for the side-effect profile observed between the treatment groups (P=0.47).. This study suggests that brinzolamide may be safely added to TTFC therapy to provide further significant reduction in IOP patients with ocular hypertensive or primary open-angle glaucoma.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Sulfonamides; Thiazines; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

To compare the intraocular pressure (IOP)-lowering effects of 0.005% latanoprost to that of 0.004% travoprost in eyes with open-angle glaucoma (OAG).. Forty-two patients with OAG who received either latanoprost or travoprost every evening for 12 weeks, and then switched to the other medication for another 12 weeks. The IOP measurements were made with a Goldmann applanation tonometer (GAT) at the baseline, and at 1, 3, 4, and 6 months after the treatment. The IOP at the untreated baseline and at the end of each treatment period was measured at 10:00, 12:00, and 16:00 hours. The central corneal thickness (CCT) was measured at each visit using an ultrasonic pachymeter.. The mean baseline IOP was 13.9 ± 2.5 mmHg, and the CCT was 536.7 ± 30.5 μm. Latanoprost reduced the IOP by 2.5 ± 1.7 mmHg and travoprost by 2.6 ± 1.5 mmHg from the baseline (p = 0.6807). The CCT decreased significantly to 531.9 ± 30.3 at 3 months (p = 0.0160) and to 529.4 ± 30.5 μm at 6 months (p = 0.0002) after the therapy. The decrease was significantly greater in eyes after travoprost (p = 0.0049).. Travoprost has similar effect as latanoprost in reducing the IOP in glaucoma patients with relatively low IOPs. The use of prostaglandin analogs can decrease the CCT, and this change should be considered when the IOPs obtained by GAT are analyzed.

Topics: Adult; Aged; Antihypertensive Agents; Cloprostenol; Cornea; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

Central corneal thickness (CCT) affects intraocular pressure (IOP) readings; however, CCT influence on topical medication efficacy is unknown. We evaluated the IOP-lowering effect of topical prostaglandin analogues (PGAs) in relation to CCT.. Post hoc analysis of a randomized prospective trial.. Subjects randomized to a PGA were followed for 24 weeks and were analyzed for relationship between CCT and IOP lowering.. Patients with either newly diagnosed ocular hypertension or open-angle glaucoma.. 75 subjects were enrolled. The mean age was 62.7 ± 10.5 years; 48 were Caucasian. The mean CCT was 562.4 ± 41.4 μ. At repeated measures, ANCOVA analysis showed a significant effect of both baseline IOP (p < 0.0001) and CCT (p = 0.003) on IOP. At week 12, a regression analysis of the effect of CCT on baseline IOP showed that for every 10 μ increase in CCT there was 0.3 mm Hg less IOP decrease from baseline.. We found a statistically significantly association between a lower mean IOP and a thinner cornea when baseline IOP is controlled for. The magnitude of the relationship is small but may be clinically significant in patients with either very thin or very thick corneas.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome

To compare the ocular hypotensive effect of tafluprost with prostaglandin analogues (PGAs) in glaucoma patients.. 89 primary open-angle glaucoma patients treated with bimatoprost, latanoprost, or travoprost for at least 3 months complaining for ocular discomfort were switched to tafluprost. IOP was assessed at baseline and 3 months after switching the therapy by daily curve. Primary outcome was to compare the mean daily IOP of tafluprost with PGAs.. The mean daily IOP was 16 ± 2.1 and 16.6 ± 2.0 mm Hg at baseline and after switching to tafluprost, respectively (P > 0.05). When analysis was carried out between tafluprost and each previous PGAs, the comparison between latanoprost and tafluprost and travoprost and tafluprost did not show any statistically significant difference in mean daily IOP and at each time point. The comparison between bimatoprost and tafluprost showed a statistically significant difference in mean daily IOP (P < 0.05) and at each time point (P < 0.05).. After 3 months of switching tafluprost showed an overall IOP lowering effect similar to others PGAs. When each PGA was compared with tafluprost, bimatoprost showed to provide a statistically significant additional IOP lowering effect.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Time Factors; Travoprost; Treatment Outcome

Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC) allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints.. The study is a randomised controlled trial (RCT) with glaucoma (open angle) or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert dosing aid, TDA), will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives.. This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area. Using a variety of adherence measures allows examination of the known inaccuracies of patient self-report with respect to glaucoma medication. The novel BCC component has undergone fidelity testing using BECCI and the BCC template will ensure conformity to a standardised intervention.. Current Controlled Trials: ISRCTN89683704.

Topics: Antihypertensive Agents; Clinical Protocols; Cloprostenol; Cognitive Behavioral Therapy; Cost-Benefit Analysis; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Medication Adherence; Ocular Hypertension; Patient Education as Topic; Travoprost

To evaluate the effect of prostaglandin analogues on the central corneal thickness (CCT) of patients with chronic open-angle glaucoma (COAG).. One hundred and twenty-nine eyes were included in this study. Of these, 108 were treated with prostaglandin analogues (latanoprost, travoprost and bimatoprost), while 21 eyes treated with β-blockers were used as controls. CCT was measured before treatment and at 3-month intervals.. A slight but significant increase in CCT was recorded in the bimatoprost and latanoprost groups. Treatment with bimatoprost produced a constant increase (1.85-8.83 μm) in CCT at all time-points of the study. The CCT rise found in the latanoprost group was significant for the first year. Treatment with travoprost did not affect CCT.. The possibility of corneal thickening under prolonged, local prostaglandin treatment should be investigated further. However, in clinical practice, CCT changes may sometimes influence intraocular pressure measurements significantly.

Topics: Adrenergic beta-Antagonists; Aged; Amides; Bimatoprost; Cloprostenol; Cornea; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost; Ultrasonography

To evaluate bimatoprost versus latanoprost and timolol fixed combination (LTFC) over the 24-hour diurnal curve in patients who switched from timolol.. In this prospective, observer-masked, randomized clinical trial, 64 patients whose intraocular pressures (IOPs) were not effectively controlled with timolol were enrolled. At pretrial visit IOPs and central corneal thickness were measured. After the baseline visit, timolol was replaced by bimatoprost or LTFC. IOPs were recorded at 8 AM, noon, 4 PM, 8 PM, midnight, and 4 AM at baseline, week 8, and week 16 visits.. At baseline and week 8 visits, there was no significant difference between the LTFC and bimatoprost group for the mean IOPs at 6 time points in 24 hours, the mean diurnal IOP, and range of diurnal IOP. At week 16, the mean IOP of the bimatoprost group (15.7±2 mm Hg) at 8 AM and 12 o' clock, midnight, was statistically significantly lower than that of the LTFC group (16.8±1.5 and 16.9±1.7 mm Hg; P=0.03 and 0.002). A statistically significant difference was not found between the proportions of patients who had 15% and 20% decrease in mean diurnal IOP and the mean daytime, nighttime, diurnal IOP reductions of the 2 study groups at weeks 8 and 16 (P>0.05). In the bimatoprost group punctate epitheliopathy, conjunctival hyperemia, and lid erythema were found to be more frequent.. The LTFC and bimatoprost therapies were equally effective in maintaining IOP at lower levels during the 24-hour period in patients who switched from timolol therapy. Adverse events were more frequent with bimatoprost therapy.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Treatment Outcome; Vision Disorders; Visual Fields

This prospective, multicenter, single-masked study evaluated the additive effect of dorzolamide hydrochloride 2% on the diurnal intraocular pressure (IOP) curve and retinal and retrobulbar hemodynamics in patients with primary open-angle glaucoma (POAG) treated with morning-dosed bimatoprost 0.03%.. Eighty-nine patients (aged, 60.7 ± 11.8 years, range 33-80; 68 women) with POAG received bimatoprost dosed once in the morning for 1 month, after which dorzolamide was added twice daily for 2 months. IOP (Goldmann) and arterial blood pressure (BP) and diurnal ocular perfusion pressures (OPP) were measured every 2 hr for 24 hr. Heidelberg retina flowmetry of the retinal microcirculation was recorded four times daily in 64 patients and colour Doppler imaging of the ophthalmic and central retinal arteries was recorded five times daily in 25 patients. All measurements were taken after the two phases of treatment and compared using anova analysis with Bonferroni adjustment.. Mean baseline IOP was 16.5 ± 3.4 mmHg. Mean diurnal IOP with dorzolamide adjunctive therapy (12.9 ± 2.1 mmHg) was significantly lower compared to mean IOP with bimatoprost monotherapy (13.6 ± 2.2 mmHg) (p = 0.03). Adjunctive dorzolamide therapy significantly decreased vascular resistance in the ophthalmic artery (p = 0.02). Mean diastolic BP and OPP were significantly lower after adjunctive therapy. There were no changes in retinal microcirculation between the two phases of treatment.. Adjunctive dorzolamide therapy to morning-dosed bimatoprost 0.03% reduced diurnal IOP and vascular resistance in the ophthalmic artery but did not alter retinal circulation in this group of patients with POAG.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Blood Flow Velocity; Blood Pressure; Circadian Rhythm; Cloprostenol; Drug Administration Schedule; Drug Therapy, Combination; Eye; Female; Glaucoma, Open-Angle; Hemodynamics; Humans; Intraocular Pressure; Laser-Doppler Flowmetry; Male; Middle Aged; Ophthalmic Artery; Prospective Studies; Retinal Artery; Single-Blind Method; Sulfonamides; Thiophenes; Tonometry, Ocular; Ultrasonography, Doppler, Color

To compare the efficacy of latanoprost, travoprost and bimatoprost given in the evening on the 24-hour intraocular pressure (IOP) curve in open-angle glaucoma patients.. It was a case-control study. Patients with primary open-angle glaucoma were selected for the present study. Twenty-one, 22 and 20 patients were treated once daily with latanoprost, travoprost and bimatoprost for 4 weeks, respectively. Before and four weeks after the treatment, IOP was measured by masked evaluators at 8AM, 10AM, noon, 2PM, 4PM, 6PM, 8PM, 10PM, midnight, 2AM, 4AM and 6AM. Repeated measure analysis of variance was used to compare the IOP responses to the drug regimens for the entire circadian curve. Analysis of variance was used to compare the circadian variations of intraocular pressure.. The IOPs of all patients in these 3 groups decreased markedly after 4 weeks. The daily average IOP (mean ± standard deviation) in the latanoprost group decreased from (18.9 ± 2.1) mm Hg (1 mm Hg = 0.133 kPa) to (15.3 ± 2.7) mm Hg, and the extent of the decrease was 19.0%. IOP in the travoprost group decreased from (19.1 ± 3.1) mm Hg to (15.3 ± 2.1) mm Hg, with a decrease of 19.4%. IOP in the bimatoprost group decreased from (18.6 ± 1.9) mm Hg to (14.9 ± 1.9) mm Hg, with a decrease of 19.9%. The effectiveness of the treatments did not differ significantly between these three groups (F = 1.501, P = 0.110). The descending percentage compared with circadian variation ranges before treatment in patients with latanoprost, travoprost and bimatoprost was 31.0%, 31.1% and 31.9%, respectively. In comparison of these three groups, the circadian variations of intraocular pressure did not differ significantly (F = 0.286, P = 0.752).. This study demonstrated that latanoprost, travoprost and bimatoprost are all effective in reducing IOP over the 24-hour curve in primary open-angle glaucoma. On the basis of our data, there was no statistically significant difference in the IOP reduction between these three drugs.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Case-Control Studies; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

To compare the effects of latanoprost, travoprost, and bimatoprost on central corneal thickness (CCT).. A total of 69 eyes of 69 patients with glaucoma or ocular hypertension submitted to monotherapy with prostaglandin analogues (latanoprost 0.005%, travoprost 0.004%, or bimatoprost 0.03%) during a mean of 17.19 ± 15.71 months follow-up period. Measurements were performed at the initial diagnosis and at the end of follow-up. All the measurements were carried out by the same doctor between 9 am and 11 am, using Goldmann applanation tonometer for intraocular pressure and ultrasonic pachymetry for CCT.. A statistically significant reduction in CCT was observed in all groups (P < 0.001). The reduction of CCT in the latanoprost, travoprost, and bimatoprost groups was 14.95 ± 5.04, 15.73 ± 3.25, and 17.00 ± 6.23 μm, respectively. No significant difference was found in the reduction of CCT among the 3 groups (P > 0.05). No significant difference was also found in the reduction of CCT between the patients with less than or equal to 6 months' treatment and the patients with more than 6 months' treatment in the 3 groups (P > 0.05).. Topical therapy with prostaglandin analogues is associated with CCT reduction. Latanoprost, travoprost, and bimatoprost have a similar effect on CCT.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Body Weights and Measures; Cloprostenol; Cornea; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Ultrasonography

To compare the efficacy and safety of timolol 0.5% versus brinzolamide 1.0% when added to travoprost monotherapy in patients with primary open-angle glaucoma or ocular hypertension.. Patients meeting selection criteria (IOP one eye 19 mmHg and ≤32 mmHg and IOP both eyes ≤32 mmHg at 8:00 h) were switched to travoprost monotherapy for 4 weeks. Patients then insufficiently controlled on travoprost (IOP at 8:00 h ≥19 mmHg) at baseline were randomized to receive either travoprost and brinzolamide or travoprost and timolol in a double-masked fashion for 12 weeks.. Two hundred and fifty-three patients underwent the 4-week run-in period. Switching to travoprost resulted in adequate IOP control (<19 mmHg) for 21.7% of patients. After 3 months of treatment, both drug combinations statistically significantly reduced the mean IOP at each time point (8:00, 12:00 and 16:00 h) and the mean diurnal IOP, which was 17.9 ± 2.6 mmHg for the brinzolamide group and 17.0 ± 3.2 mmHg for the timolol group. Both combinations were well-tolerated. However, a statistically significant difference occurred at 16:00 h, with pressures of 16.4 ± 3.2 mmHg and 17.3 ± 2.8 mmHg for the timolol and brinzolamide groups, respectively (p = 0.038). Fifty percent of patients reported one adverse event, whereas in 13.2% three or more adverse effects were named. Hyperemia was found most often (6.3% of the patients).. Both adjunctive combinations moderately reduced IOP in patients inadequately controlled with travoprost monotherapy, with timolol being slightly stronger 8 hours after instillation. Adjunctive treatment with brinzolamide and travoprost may be an alternative for patients not tolerant or not responsive to treatment with timolol and travoprost.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Sulfonamides; Thiazines; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension.. In this prospective randomized controlled trial, subjects with IOP of at least 22  mm Hg in one or both eyes at 0900  h, and IOP of at least 21  mm Hg in one or both eyes at 1100  h and 1600  h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900  h) for 6 weeks. IOP was assessed at 0900  h, 1100  h, and 1600  h at each scheduled visit (baseline, 2 and 6 weeks after randomization).. Mean IOP reduction across all visits and time points was 8.0  mm Hg in the TRA/TIM BAK-free group and 8.4  mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7  mm Hg across visits and time points, with a mean pooled difference of 0.4  mm Hg (95% CI: -0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group.. Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Japan; Logistic Models; Male; Middle Aged; Ocular Hypertension; Polymers; Prospective Studies; Timolol; Travoprost; United States

To evaluate the efficacy between Travoprost 0.004%/Timolol 0.5% fixed combination, Latanoprost 0.005%/ Timolol 0.5% fixed combination once a day in the morning and Timolol 0.5% twice a day in a 24-hour intraocular pressure control (IOP).. The patients with primary open angle glaucoma and ocular hypertension was subjected. After 2-4 weeks of washout period, patients with daytime IOP > or = 21 mmHg and < 36 mmHg were admitted to the hospital for 24-hour IOP monitoring every 3-hour interval starting from 9 am to 9 am the next day. The patients were randomly received Travoprost-Timolol fixed combination, Latanoprost-Timolol fixed combination once a day or Timolol twice a day in the studied eyes. Another 24-hour IOP monitoring was taken again 2 weeks later.. 59 eyes from 32 patients were subjected. The mean initial IOP at 9 am was 21.6 mmHg. The mean reduction of IOP ranging from 1.6 to 7.3 mmHg for Travoprost-Timolol group, 1.5 to 8.2 mmHg for Latanoprost-Timolol group and 2.2 to 5.6 mmHg for Timolol group. All three groups produced statistically significant reduction (p < 0.05) in mean IOP at all test times except; at 3 am for the Travoprost-Timolol group; at 3 am, 12 midnight-and 6 pm in the Latanoprost-Timolol group; and at 3 am and 9 pm in the Timolol group. The effects of IOP reduction of the combination drugs were greatest between 9 am and 3 pm with the morning dose of both combinations. There was no statistically significant difference in mean IOP reduction at any test time between the 2 combination drug groups but they were both better than Timolol alone at 9 am and 3 pm.. A fixed combination of Travoprost 0.004% and Timolol 0.5% is as effective as a fixed combination of Latanoprost 0.005% and Timolol 0.5% and are better than Timolol 0.5% in 24-hour IOP control.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Time Factors; Timolol; Travoprost; Treatment Outcome; Young Adult

To investigate the validity of the monocular therapeutic trial of therapy in patients commencing topical glaucoma treatment.. Prospective intention-to-treat cohort study of untreated patients presenting with open-angle glaucoma or ocular hypertension.. We included 30 treatment-naïve subjects.. All subjects had 8 visits at which intraocular pressure (IOP) was measured by masked Goldmann tonometry. After the recruitment visit, IOP was measured in both eyes at 11 am for 7 consecutive weeks. At week 3, travaprost (0.001%) was commenced in the eye with the higher IOP and at week 4 travaprost was also commenced in the fellow eye.. Three IOP outcomes were measured for the trial eye: (1) Unadjusted IOP-lowering effect (difference between recruitment IOP and first IOP on treatment); (2) adjusted IOP-lowering effect (unadjusted effect - [difference between IOPs at the same visits in the fellow eye]); and (3) true therapeutic effect (mean difference between 3 baseline pretreatment IOPs and 3 IOPs on treatment).. Mean recruitment IOPs were 28.2 and 26.0 mmHg in the trial and fellow eyes, respectively. The mean baseline IOPs were 25.8 and 22.7 mmHg in the trial and fellow eyes, respectively, indicating that regression to the mean was responsible for 2.4 and 3.3 mmHg, respectively, in the trial and fellow eyes. The unadjusted treatment effect (11.7 mmHg) overestimated the true effect (8.6 mmHg) by a mean of 3.1 mmHg, whereas the mean adjusted IOP was almost identical to the true effect. The correlation between the unadjusted effect of treatment and the true effect was 0.55, whereas the effect when adjusted by the monocular trial was 0.72.. In our cohort of patients with bilateral IOPs >21 mmHg at baseline, the monocular trial provides a significantly more accurate estimate of the therapeutic response when initiating prostaglandin monotherapy in untreated eyes. It is particularly helpful in avoiding overestimation of effectiveness and so reducing the number of patients on inadequate treatment.. The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

Patients with glaucoma or ocular hypertension who do not achieve target intraocular pressure (IOP) using one hypotensive agent are often transitioned to combination therapy. Travoprost 0.004%/timolol 0.5% fixed combination (TTFC) has shown efficacy in patients whose IOP is not controlled with other therapies. The goal of this study was to assess the efficacy and safety of transitioning to TTFC in patients whose IOP was uncontrolled on bimatoprost 0.03%/timolol 0.5%, administered concomitantly or as a fixed combination.. This was a prospective, open-label, multicenter study of patients with open-angle glaucoma or ocular hypertension who transitioned to TTFC from fixed or unfixed bimatoprost/timolol. Patients self-administered TTFC once daily for 8 weeks, and efficacy and safety were assessed at baseline, Week 4, and Week 8. A symptom survey was administered at baseline and Week 8. Both patients and investigators reported their medication preference at Week 8.. A total of 105 patients were enrolled in the study. Mean IOP decreased by 16.5% from baseline after 8 weeks of TTFC therapy in the total population, 15.0% in patients transitioning from fixed-combination therapy, and 20.8% in patients transitioning from unfixed therapy (P<0.001 for all groups). The percentage of patients reaching target IOP (≤18 mmHg) after treatment with TTFC was 69.2% (P<0.001). Patients judged stinging/burning to be less severe with TTFC than with prior therapy (P=0.029); all other symptom frequencies and severities were similar for both treatments. Patients preferred TTFC over bimatoprost/timolol (fixed and unfixed) at a ratio of more than 4:1 (81.4% vs. 18.6%; P<0.001), and investigators reported a nearly five-fold preference for TTFC (83.3% vs. 16.7%; P<0.001). No unexpected safety concerns with TTFC were observed.. Travoprost 0.004%/timolol 0.5% fixed combination produced a significant reduction in IOP, with favorable safety and tolerability profiles. Both patients and investigators strongly preferred TTFC to prior bimatoprost 0.03%/timolol 0.5% therapy.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Timolol; Travoprost

To evaluate the efficacy and safety of replacing latanoprost with another prostaglandin analogue (PGA) in patients with glaucoma or ocular hypertension requiring additional intraocular pressure (IOP) lowering while on latanoprost.. Prospective, randomised, investigator-masked, multicentre clinical trial. Patients on latanoprost 0.005% monotherapy requiring additional IOP lowering discontinued latanoprost and were randomised to bimatoprost 0.03% (n = 131) or travoprost 0.004% (n = 135). IOP was measured at latanoprost-treated baseline and after 1 month and 3 months of replacement therapy.. Baseline mean diurnal IOP on latanoprost was similar between groups. The mean diurnal IOP was significantly lower with bimatoprost than with travoprost at 1 month (p = 0.009) and 3 months (p = 0.024). Overall, 22.0% of bimatoprost patients versus 12.1% of travoprost patients achieved a > or =15% reduction in diurnal IOP from latanoprost-treated baseline at both months 1 and 3 (p = 0.033). At month 3, the additional mean diurnal IOP reduction from latanoprost-treated baseline was 2.1 (95% CI 1.7 to 2.5) mm Hg (11.0%) with bimatoprost and 1.4 (95% CI 0.9 to 1.8) mm Hg (7.4%) with travoprost (p = 0.024). At 3 months, 11.5% of bimatoprost and 16.5% of travoprost patients demonstrated a > or =1-grade increase in physician-graded conjunctival hyperaemia (p = 0.288). Hyperaemia was reported as a treatment-related adverse event in 3.1% of bimatoprost and 1.5% of travoprost patients (p = 0.445).. Patients on latanoprost requiring lower IOP achieved a greater additional short-term diurnal IOP reduction when latanoprost was replaced by bimatoprost compared with travoprost. Low rates of hyperaemia were observed in patients treated with bimatoprost or travoprost after switching from latanoprost.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Travoprost; Treatment Outcome; Young Adult

To compare 24 h intraocular pressure (IOP) control of morning and evening administered bimatoprost/timolol fixed combination (BTFC) and evening administered bimatoprost in exfoliative glaucoma (XFG).. One eye of 60 XFG patients was included in this prospective, observer-masked, crossover comparison. Following wash-out, all patients received bimatoprost monotherapy for 6 weeks. They were then randomised to morning, or evening, administered BTFC for 3 months and then switched to the opposite therapy.. At baseline, mean 24 h pressure was 29.0 mm Hg. Bimatoprost reduced the mean IOP by 8.1 mm Hg (27.8%, p<0.001). The evening administration of BTFC reduced 24 h IOP to a statistically lower level than morning administration (10.2 mm Hg (35.3%) vs 9.8 mm Hg (33.8%); p=0.005). Both dosing regimens reduced IOP significantly more than bimatoprost (p < or = 0.006, for all time points). A 24 h IOP reduction > or = 30% was seen in 43 patients (72%) with evening BTFC compared with 39 patients (65%) with morning BTFC (p=0.344) and only 24 patients (40%) with bimatoprost monotherapy (p<0.001 vs both BTFC regimens).. Both BTFC dosing regimens significantly reduce 24 h IOP in XFG compared with bimatoprost monotherapy. The evening dosing gives rise to statistically better 24 h IOP control and could be considered in these patients.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Drug Administration Schedule; Drug Combinations; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Single-Blind Method; Timolol; Treatment Outcome

Latanoprost, travoprost, and bimatoprost are prostaglandin or prostamide-type ocular hypotensive medications, all of which are effective and safe for lowering intraocular pressure (IOP). Most studies with these types of drugs have included patients mainly from European or white ethnic backgrounds; however, some reports have suggested that there is a difference in response between patients of white and African racial heritage. On account of the possibility that drugs may act differently in people of different ethnic background, we decided to study the effectiveness and safety of all 3 drugs in people from various ethnic heritages. Our hypothesis was that there might be a possible ethnic-based difference in IOP-lowering effectiveness between the 3 medications.. This was a prospective randomized investigator-masked multicenter study. Patients newly diagnosed with open-angle glaucoma (primary, pseudoexfoliative, or pigmentary), or whose pressure became elevated after a washout period, were randomized to receive 1 of 3 prostaglandin/prostamide drugs. Assignment of drug was balanced by racial group and study site, and the investigator was masked to the drug used. The patients were requested to self-identify their racial group as White, African, East Indian, Asian, or Hispanic; to minimize the possibility of heterogeneity, all 4 grandparents had to be known to originate from the same group. However, for purposes of analysis, the patients were divided into 2 groups--White or Other. Patients were followed at 2, 6, 12, and 24 weeks; IOP and local side effects were assessed at each visit.. Eighty-three patients were recruited from 9 sites. The mean age of the patients was 61.5 ± 10.5 years. There were no differences in mean age or the distribution of sex between the patients whether examined by the 2 racial groups or the 3 drug groups. There was a highly statistically significant decrease in IOP from baseline to 12 weeks and from baseline to 24 weeks (F = 439.3, P<0.0001; F = 305.94, P<0.0001). There were no differences in treatment effect between the 3 drugs or between the 2 ethnic groups, (P > 0.05 for all comparisons) and there was no interaction between race and drug.. All 3 prostaglandin/amide drugs are highly effective at lowering IOP. No differences in effect between the drugs or between members of different racial groups were detected, although the study sample size was too small to be certain to detect differences, if they existed.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Ethnicity; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

To investigate the effects of switching to SofZia-preserved travoprost (TRV) on superficial punctate keratopathy (SPK) observed in patients using benzalkonium chloride (BAC)-preserved latanoprost (LAT).. Patients with either primary open-angle glaucoma or ocular hypertension treated with LAT for at least 1 month who presented with SPK participated in this prospective, multicenter, open-label uncontrolled study. After the switch from LAT to TRV, patients were monitored at 2 weeks and at 1, 2, and 3 months. The use of concomitantly employed ophthalmic solutions was continued during the observation period. The intensity of SPK in each of five areas defined on the cornea was scored on a standard scale. Repeated measurements were tested with a linear mixed model.. Of the 48 patients enrolled, 45 patients completed the study. After the switch to TRV, the mean SPK score in the whole cornea decreased significantly at every observation point (P < 0.0001 at each point) while intraocular pressure did not change significantly. Throughout the observation period, the SPK score tended to be higher in patients using a larger number of concomitant medications that contained BAC.. Switching to TRV improved SPK observed in a population using LAT, likely because of a decrease in exposure to BAC.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Corneal Diseases; Female; Fluorophotometry; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

To assess adherence in glaucoma patients using the Travatan Dosing Aid (TDA); to record differences in adherence by age, sex, therapy, systemic therapies, years from diagnosis, type of therapy and intraocular pressure (IOP).. Sixth-month cohort study; fifty-six Caucasian, primary open-angle glaucoma patients on travoprost (T) or travoprost/timolol fixed combination (TTFC) monotherapy were submitted to four visits: at baseline and months 1, 3 and 6 (M1, M3, M6). Adherence was recorded with TDA and classified as 'high' if greater than 90%. Self-reported and physician-presumed adherence data were collected. Kruskall-Wallis and Fisher's exact tests were applied.. Thirty-two patients (54.2%) were treated with T. Age, sex, level of schooling, presence of systemic comorbidities, duration of current therapy and IOP were similar between T and TTFC. Seventeen subjects (30.3%) recorded high adherence at every visit, 13 (23.2%) at two visits, 26 (46.4%) otherwise. Adherence was maintained over time with a slight decrease from month 1 to month 6 without statistical differences within and between groups. Adherence was statistically influenced by age (p = 0.007) and duration of therapy (p = 0.004).. The typical nonadherent patient is elderly. TDA records indicate that only a minority of patients are really adherent: predictive models to screen for poor adherence are needed.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Drug Combinations; Drug Monitoring; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Ophthalmic Solutions; Patient Compliance; Prospective Studies; Timolol; Travoprost; Treatment Outcome

To quantify the aqueous humor (AH) concentrations of bimatoprost (amide), travoprost (isopropyl ester), and their hydrolysis products, bimatoprost free acid (BFA) and travoprost free acid (TFA), after multiple topical ocular doses of LUMIGAN and TRAVATAN, respectively, in patients awaiting cataract surgery.. In 2 separate open-label, sparse-sampling trials, glaucoma patients with cataracts received LUMIGAN (bimatoprost ophthalmic solution, 0.03%) or TRAVATAN (travoprost ophthalmic solution, 0.004%) bilaterally once daily for at least 21 days prior to cataract surgery. Anterior chamber paracentesis was performed at selected times up to 5 h after the last dose and an AH sample was collected. AH samples were assayed by an independent bioanalytical laboratory using a sensitive and validated tandem LC-MS/MS method. The assay lower limits of quantitation were 0.59 nM for bimatoprost, 0.29 nM for BFA, and 0.44 nM for TFA.. AH concentrations of BFA (17-phenyl-trinor PGF(2alpha)) were quantifiable in all but one sample at 0.5 h. The maximum concentration achieved (C(max)) of BFA was 30.9 + or - 16.41 nM (n =5), observed at 2 h postdose. AH concentrations of bimatoprost amide were lower than BFA at all time points, with a C(max) of 6.81 + or - 1.36 nM (n = 7) at 1 h postdose. For TFA, measurable AH concentrations were obtained at all time points with a TFA C(max) of 3.91 + or - 2.27 nM (n = 5), which was observed at 3 h after the dose (all data are mean + or - SEM).. Once daily topical ocular administration of LUMIGAN or TRAVATAN for 3 weeks resulted in significant concentrations of BFA and TFA in the AH. Quantifiable levels of bimatoprost amide were also measured. Maximum concentrations of BFA (30.9 nM) and TFA (3.91 nM) in the anterior chamber are sufficient to fully activate the FP prostanoid receptors in the target cells of the ciliary muscle and trabecular meshwork. Both bimatoprost in LUMIGAN and travoprost in TRAVATAN are essentially prodrugs that are rapidly hydrolyzed to their respective free acids that induce the IOP-lowering effect observed with both drugs in vivo.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Biological Availability; Cataract Extraction; Chromatography, Liquid; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Tandem Mass Spectrometry; Travoprost

To compare the efficacy and tolerance of three prostaglandin analogues, bimatoprost, latanoprost and travoprost in patients with previously untreated open-angle glaucoma and ocular hypertension.. Prospective randomized single (investigator) masked comparative clinical trial at the Taunton and Somerset NHS Hospital, Taunton, UK. Newly diagnosed, treatment naïve glaucoma/ocular hypertension patients were recruited. Patients were randomized into three groups to receive one of the three prostaglandin analogues. Intraocular pressure (IOP) was measured before starting treatment and after 2 and 6 months of treatment. The IOP reduction and the tolerance profile of each drug were compared. The data were analysed on the basis of intention to treat, using analysis of covariance comparing IOP in the three groups at 2 and 6 months, adjusting for baseline IOP. Tolerance levels were compared using Kruskal-Wallis test.. Of the 122 patients, 40 patients were given bimatoprost, 42 received latanoprost and 40 had travoprost. At 2 months, there was a significant difference between the three treatment groups (P = 0.013) with bimatoprost achieving a greater reduction in IOP than the other two drops. However, at 6 months, the difference was not statistically significant (P = 0.13). There was no significant difference in the tolerance profile.. All the three topical prostaglandin analogues are effective at lowering IOP, but bimatoprost was found to be most effective in the initial phase of the trial, and there was no statistically significant difference in the efficacy, among the three prostaglandin analogue eye drops after 6 months of treatment.

Topics: Adult; Aged; Aged, 80 and over; Amides; Bimatoprost; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Low Tension Glaucoma; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

To assess the additive effect of dorzolamide hydrochloride 2% on the diurnal intraocular pressure (IOP) curve and retrobulbar haemodynamics in patients with primary open-angle glaucoma (POAG) treated with morning-dosed bimatoprost 0.03%.. Twenty-five patients with POAG were evaluated in a prospective, single-masked study. After a 1 week run-in period with bimatoprost all patients were treated with bimatoprost dosed once in the morning for 1 month, after which dorzolamide was added twice daily for 2 months. Goldmann applanation IOP, arterial blood pressure (ABP) and heart rate were measured every 2 h for 24 h and diurnal ocular perfusion pressure (OPP) was calculated. Colour Doppler imaging (CDI) of the ophthalmic artery (OA) and the central retinal artery (CRA) was recorded five times daily. All measurements were taken after the two phases of treatment and were compared.. The mean baseline IOP was 14.8 ± 3.5 mm Hg. Mean IOP following bimatoprost monotherapy (12.8 ± 2.9 mm Hg) and after 2 months of dorzolamide adjunctive therapy (12.2 ± 2.6 mm Hg) were not statistically significantly different (p=0.544). Only at the 4:00 h time point was IOP significantly reduced using the bimatoprost/dorzolamide combined treatment (p=0.013). The 24 h IOP fluctuations were lower when dorzolamide was added (6.0 ± 2.3 mm Hg vs 4.6 ± 1.5 Hg, p=0.0016). Repeated analysis of variance detected a significant decrease of vascular resistance in the OA (p=0.0167) with adjunctive dorzolamide treatment.. The addition of dorzolamide to morning-dosed bimatoprost had an additive hypotensive effect only on the night-time IOP curve at 4:00 h and resulted in a lower IOP fluctuation. Dorzolamide added to bimatoprost may reduce vascular resistance in the OA.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Blood Flow Velocity; Cloprostenol; Drug Synergism; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Hemodynamics; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Artery; Ophthalmic Solutions; Orbit; Prospective Studies; Single-Blind Method; Sulfonamides; Thiophenes

To compare the ocular surface tolerability of latanoprost 0.005% preserved with 0.02% benzalkonium chloride (BAK), bimatoprost 0.03% preserved with 0.005% BAK, and travoprost 0.004% preserved with the proprietary preservative system sofZia in patients previously treated with latanoprost.. This randomized, multicenter, investigator-masked, parallel-group study enrolled patients with open-angle glaucoma or ocular hypertension who had been on latanoprost monotherapy for at least 4 weeks. At baseline, patients were randomized to receive once-daily bimatoprost (n=35), latanoprost (n=38), or travoprost (n=33) monotherapy for 3 months. Follow-up visits were at week 1, month 1, and month 3. The primary outcome measure was physician-graded conjunctival hyperemia at month 3. Secondary outcome measures included corneal staining with fluorescein and tear breakup time (TBUT).. There were no significant differences among the treatment groups in conjunctival hyperemia scores, corneal staining, or TBUT at the latanoprost-treated baseline or at any follow-up visit. Baseline mean (standard error of the mean) values were as follows--conjunctival hyperemia: bimatoprost 0.74 (0.10), latanoprost 0.74 (0.11), travoprost 0.86 (0.12), P=0.692; corneal staining: bimatoprost 0.59 (0.12), latanoprost 0.70 (0.13), travoprost 0.48 (0.11), P=0.423; TBUT (in seconds): bimatoprost 9.1 (1.0), latanoprost 8.6 (0.8), travoprost 7.9 (0.8), P=0.578. Month 3 values were as follows--conjunctival hyperemia: bimatoprost 0.80 (0.12), latanoprost 0.74 (0.10), travoprost 0.98 (0.13), P=0.340; corneal staining: bimatoprost 0.71 (0.78), latanoprost 0.47 (0.64), travoprost 0.36 (0.62), P=0.110; TBUT (in seconds): bimatoprost 9.7 (5.3), latanoprost 9.2 (5.3), travoprost 9.7 (6.3), P=0.909.. There were no significant differences among bimatoprost (preserved with 0.005% BAK), latanoprost (preserved with 0.02% BAK), and travoprost (preserved with sofZia) in objective clinical measures of ocular tolerability, including physician-graded hyperemia, corneal staining, and TBUT after 3 months of treatment. Longer-term studies are needed to further evaluate the ocular surface tolerability of these prostaglandin analogs.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Benzalkonium Compounds; Bimatoprost; Cloprostenol; Conjunctiva; Cornea; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Single-Blind Method; Tears; Travoprost; Treatment Outcome

To compare the ocular hypotensive effect of bimatoprost plus timolol and travoprost plus timolol fixed combinations in glaucoma patients whose disease was controlled but had not reached their target intraocular pressure (IOP) with the fixed combination of latanoprost plus timolol.. A 2 × 3-month, multicenter, prospective, randomized, double-masked, cross-over clinical trial.. Eighty-nine open-angle glaucoma (OAG) patients were included. After a 6-week run-in period with latanoprost plus timolol, patients were randomized to either travoprost plus timolol or bimatoprost plus timolol for 3 months. Patients then switched to the opposite therapy for 3 additional months. The primary end point was the comparison of mean daily IOP after 3 months of each treatment.. At baseline, mean IOP was 16.5 mm Hg (95% confidence interval, 16.0 to 17.0 mm Hg) with treatment with latanoprost plus timolol. Both bimatoprost plus timolol and travoprost plus timolol statistically significantly reduced the mean IOP from baseline (P < .0001). Mean IOP at month 3 was statistically significantly lower in the bimatoprost plus timolol group compared with the travoprost plus timolol group (14.7 mm Hg [95% confidence interval, 14.3 to 15.3 mm Hg] vs 15.4 mm Hg [95% confidence interval, 15.0 to 15.9 mm Hg]; P = .0041). IOP was lower during bimatoprost plus timolol treatment at all time points and statistical significance was reached at 8 am, 11 am, and 5 pm, but not at 2 pm and 8 pm. Both treatments showed similar tolerability profile.. Bimatoprost plus timolol and travoprost plus timolol can provide additional IOP-lowering effect in patients not fully controlled with latanoprost plus timolol. The observed additional IOP reduction was greater with bimatoprost plus timolol with a similar tolerability profile.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Combinations; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Latanoprost; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Travoprost; Visual Acuity

Travoprost has been widely used for the treatment of patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The aim of this study was to evaluate the intraocular pressure (IOP) lowering efficacy of travoprost 0.004% monotherapy in patients previously treated with other topical hypotensive medications, and in previously untreated patients.. This open-label, 12-week study in 1651 adult patients with ocular hypertension or open-angle glaucoma who were untreated or required a change in therapy (due to either inadequate efficacy or safety issues) as judged by the investigator was conducted at 6 sites in China. Previously treated patients were instructed to discontinue their prior medications at the first visit. All the patients were dosed with travoprost 0.004% once-daily at 8 p.m. in both eyes for 12 weeks. Efficacy and safety evaluations were conducted at week 4 and 12. IOP measurements were performed at the same time of day at the follow-up visits.. For patients transitioned to travoprost, mean IOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were: latanoprost, (4.3 +/- 4.6) mmHg; beta-blocker, (6.3 +/- 4.0) mmHg; alpha-agonist, (7.5 +/- 4.3) mmHg; topical carbonic anhydrase inhibitors, (8.0 +/- 4.9) mmHg. All mean IOP changes from baseline were statistically significant (P < 0.001). No treatment-related serious adverse events were reported in this study.. In patients treated with other hypotensive medications or untreated, the IOP reduction with travoprost was significant. The results of this study demonstrated the potential benefit of using travoprost as a replacement therapy in order to ensure adequate IOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Travoprost; Treatment Outcome

To compare the efficacy of bimatoprost and travoprost on intraocular pressure (IOP) reduction in an Egyptian population.. Patients with primary open-angle glaucoma or ocular hypertension were randomized to receive either bimatoprost 0.03% or travoprost 0.004% once daily. IOPs were measured at baseline; 2 weeks; and 1, 2, 4, and 6 months using Goldman applanation tonometery.. Seventy-two patients were included: 34 and 38 (P = 0.142) with a baseline mean IOP = 26.52 ± 5.185 and 26.36 ± 1.605 mm Hg (P = 0.629) for bimatoprost and travoprost, respectively. Both drops provided statistically significant IOP reductions from baseline at all visits (P < 0.001). Bimatoprost provided greater (nonsignificant) mean IOP reductions from baseline than travoprost at each visit. Mean IOP reductions was 8.77 mm Hg (33.39%) and 8.42 mm Hg (31.54%) at 2 weeks (P = 0.703), and 8.47 mm Hg (31.61%) and 7.84 mm Hg (29.50%) at 6 months (P = 0.536) for bimatoprost and travoprost, respectively. IOPs at 2 weeks were ≤18 mm Hg in 20 (58.8%) versus 19 (50%) eyes (P = 0.603), and ≤16 mm Hg in 12 (35%) versus 12 (32%) eyes (P = 0.456); and at 6 months ≤18 mm Hg in 22 (65%) versus 14 (37%) eyes (P = 0.045), and ≤16 mm Hg in 12 (35%) versus 7 (18%) eyes (P = 0.037) for bimatoprost and travoprost, respectively. Ocular adverse and clinical success occurred equally with both drops.. Both drops lowered IOP effectively but bimatoprost showed a greater non-significant reductions in mean IOP from baseline.

Topics: Administration, Topical; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Egypt; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Travoprost

The purpose of this study was to assess both the benefits of a 3-month travoprost 0.004%/timolol 0.5%fixed combination (trav/tim) regimen in comparison with previous medications for the control of intraocular pressure (IOP) and the tolerability of these drug regimens in glaucoma patients. An observational, non-interventional, open-label study of 406 eyes with primary open angle glaucoma and ocular hypertension was thus undertaken. One drop of trav/tim fixed combination was administered in the evening for 3 months. Patients were divided into five groups according to previous drug regimens: timolol 0.5% monotherapy; betaxolol 0.5% monotherapy; latanoprost 0.005% monotherapy; travoprost 0.004% monotherapy; and dorzolamide 2%/timolol 0.5% fixed combination. Upon medication substitution, the trav/tim fixed combination provided better IOP control and tolerability in all five patient groups. At the 3-month follow up, the mean IOP changes from previous therapy were as follows: 5.2 ± 2.7 mmHg (20.8% change) in timolol 0.5% group; 5.7 ± 2.2 mmHg (22.5% change) in betaxolol 0.5% group; 3.8 ± 2.6 mmHg (24.5% change) in latanoprost 0.005% group; 4.4 ± 2.8 mmHg (20% change) in travoprost 0.004% group; and 3.4 ± 4.1 mmHg (14.5% change) in dorzolamide 2%/timolol 0.5% fixed combination group. The difference between baseline and trav/tim combination patient satisfaction at the 3-month follow-up was significant. Thus, the trav/tim fixed combination provided better IOP control and tolerability than previous mono- or polytherapies.

Topics: Antihypertensive Agents; Cloprostenol; Croatia; Drug Therapy, Combination; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Patient Satisfaction; Prospective Studies; Timolol; Travoprost; Treatment Outcome

To evaluate bimatoprost/timolol fixed combination (BTFC) vs latanoprost/timolol fixed combination (LTFC) given each evening over the 12-h intraocular pressure (IOP) diurnal curve.. A total of 54 eyes of 54 patients (24 with primary open-angle glaucoma (POAG) and 30 with pseudoexfoliative glaucoma (PXG)) were included in this prospective, randomized, evaluator-masked single centre crossover study. Patients with an IOP of >or=19 mmHg, under treatment with prostaglandin analogues, were randomized to BTFC or LTFC for a 12-week treatment period after a 6-week run-in period on timolol maleate 0.5% (one drop in each eye twice each day). Patients were then switched to the opposite treatment for the second period. Six 12-h IOP curves were recorded for each patient at baseline (under treatment with timolol maleate 0.5% BID), week 6 and 12 for each treatment period.. The 12-h IOP (mean (SD)) values were 22.0 (1.0) mmHg at baseline, 17.7 (0.8) mmHg on BTFC, and 18.5 (0.8) mmHg on LTFC (P<0.001). At individual time points, there was a significant difference between groups at 0800, 0100, 1200, 1800, and 2000 hours with BTFC having greater ocular hypotensive effect, P<0.001. The most frequently reported adverse event in the study was conjunctival hyperaemia. Average hyperaemia scores were slightly but significantly lower in the LTFC treatment period (P=0.04).. This study suggests that the evening-dosed BTFC provides better IOP control than that of LTFC over 12 h. However, the IOP difference was small and may not be clinically meaningful.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Timolol

To evaluate the change in visual function after starting glaucoma treatment and correlate this to a decrease in intraocular pressure (IOP) in primary open-angle glaucoma patients.. A prospective, randomized clinical trial was carried out involving 54 glaucoma patients (54 eyes). After inclusion, patients randomly received timolol maleate 0.5%, brimonidine tartrate 0.2%, or travoprost 0.004% in one randomly selected eye. Patients underwent Goldmann applanation tonometry, visual acuity test, standard automated perimetry (SAP), visual quality perception test (visual analogue scale), and contrast sensitivity (CS) test, in a random order before and after the 4-week glaucoma treatment.. There were statistically significant changes in IOP (mean change [standard deviation], 7.8 [3.6] mmHg, P<0.001), SAP mean deviation index (0.84 [2.45] dB, P=0.02), visual quality perception (0.56 [1.93], P=0.045), and CS at frequencies of 12 cycles/degree (0.10 [0.37], P=0.03) and 18 cycles/degree (0.18 [0.42], P=0.02) after the 4-week treatment when compared with baseline. No statistically significant differences were found between the treatment groups in visual function changes after treatment (P>0.40). No significant correlations between IOP reduction and changes in visual function were found (P>0.30).. Visual quality perception, visual field mean deviation index, and CS at higher frequencies improve after starting glaucoma therapy. However, no correlation was found between IOP reduction and changes in visual function, and no differences were found in visual function when the three medications studied were compared.

Topics: Aged; Antihypertensive Agents; Brimonidine Tartrate; Cloprostenol; Contrast Sensitivity; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Prospective Studies; Quinoxalines; Timolol; Travoprost; Visual Acuity; Visual Fields; Visual Perception

To evaluate the 24 h efficacy and safety of the travoprost/timolol maleate fixed combination (TTFC) versus travoprost when both are dosed in the evening in primary open-angle glaucoma patients.. Prospective, double-masked, crossover, active-controlled, randomised 24 h comparison. After a 6 week medicine-free period, patients were randomised to either TTFC or travoprost for 8 weeks and were then switched to the opposite treatment for another 8 weeks. At the end of the washout and treatment periods, a 24 h pressure curve was performed.. Thirty-two patients completed the study. The TTFC group demonstrated a lower absolute intraocular pressure level (2.4 mm Hg) for the 24 h curve and at all time points, compared with travoprost (p0.05).. This study suggests that when both drugs are dosed in the evening the TTFC provides improved intraocular pressure reduction, compared with travoprost, over the 24 h curve and for each individual time point in primary open-angle glaucoma patients.

Topics: Adult; Aged; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Timolol; Travoprost; Treatment Outcome

To evaluate intraocular pressure (IOP) control over 24 hours using travoprost and timolol fixed combination (TTFC) administered in the morning or evening in primary open-angle and exfoliative glaucoma.. Patients were randomized to TTFC administered in either the morning or evening for 8 weeks. Previously treated patients underwent an untreated washout period of 4-6 weeks, after which baseline IOP was required to be > 25 mm Hg and < 38 mmHg (in two readings taken at 10.00 +/- 1 hours). During the treatment period, IOP was measured at 10.00, 14.00, 18.00, 22.00, 02.00 and 06.00 hours. Patients were then treated with the opposite dosing regimen for 8 weeks and IOP measurements were repeated.. In 32 subjects who completed the study, the untreated baseline IOP following washout was 27.7 +/- 3.5 mmHg. Both dosing regimens reduced IOP from baseline at each time-point and throughout the 24-hour diurnal curve (p < 0.0001). When treatments were compared directly, evening dosing (18.4 +/- 3.3 mmHg) provided a statistically significant lower 24-hour curve than morning dosing (19.2 +/- 3.5 mmHg; p = 0.001). Evening dosing also resulted in a lower 24-hour IOP fluctuation (3.8 +/- 1.6 mmHg) than morning dosing (5.1 +/- 1.6 mmHg; p = 0.0002) and lower peak IOP (p = 0.0003).. Both morning and evening administration of TTFC provide effective 24-hour IOP reduction, but evening dosing demonstrates better 24-hour pressure control.

Topics: Adult; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Prospective Studies; Timolol; Tonometry, Ocular; Travoprost; Visual Acuity

To evaluate the intraocular pressure (IOP) lowering efficacy and safety of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension, poorly controlled with or intolerance to beta-blockers. To record the short-term effect on diastolic ocular perfusion pressure (DOPP).. One hundred and three patients with open-angle glaucoma or ocular hypertension were treated with travoprost 0.004% once daily for 90 days in an open-label, non-controlled study. Efficacy and safety were assessed at baseline, after 45 and 90 days. Clinical registry number IT0301.. The primary outcome measure, IOP, was recorded at 10 am, 12 pm, and 4 pm at each visit. DOPP was evaluated at 10 am, at baseline and visit 3. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure.. Mean IOP was reduced from 22.2 +/- 1.7 mmHg to 16.5 +/- 2.1 after 45 days (p < 0.0001), and to 16.1 +/- 2.2 after 90 days (p < 0.0001). The DOPP increased by 5.3 +/- 6.3 mmHg after 90 days of treatment (p < 0.0001). No drug related serious adverse events were reported during the study.. The open-label and non-comparative nature of the study represented its principal limitations. The study confirmed the efficacy and tolerability of travoprost in the treatment of open-angle glaucoma or ocular hypertension, in a subset of patients unsuccessfully treated with beta-blockers. In this study, travoprost significantly increased DOPP at short-term follow-up. Further studies to assess the effect of travoprost on DOPP are warranted.

Topics: Aged; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Travoprost; Treatment Outcome

To investigate the topical use of travoprost [Trademark: Travatan (Alcon laboratories Inc, TX)] and the incidence of iridial pigmentation change in the brown irises of Chinese eyes.. Prospective, masked, observational study. Enrolled in the study were 37 Chinese subjects (73 eyes) with primary open-angle glaucoma who were being treated for the first time with travoprost eye drops (patient-group). Twenty-one Chinese volunteers with normal eyes (42 eyes) served as the control-group. To evaluate iris pigmentation, photographs were taken of the control-group's irises using a slit-lamp biomicroscope with attached digital camera. Before the start of travoprost treatment and 3 months after the start of travoprost treatment, photographs of the irises of the patient-group were taken using the same photographic methods. Five glaucoma specialists independently read the series of photographs to determine if there was an increase in iris pigmentation. Three of the 5 observers had to be in agreement that there was an increase from the baseline. "Picture Color Analyzer" computer software was also used to calculate the color value of each iris picture.. Observation with eyes: Twenty-six eyes (35.6%) in the patient-group developed an increase in iris pigmentation compared with zero subjects (0%) in the control-group (P=0.000, chi(2) test). Results with Picture Color Analyzer software: On the basis of the threshold value that was obtained from the control-group, 22 eyes (30.1%, n=73) in the patient-group were shown to have developed an increase in iris pigmentation.. Contrary to the previous studies that noted that the percentage of iris hyperpigmentation caused by travoprost in homochromic brown eyes was very low, our study showed that 35.6% iris hyperpigmentation did occur, which is a considerably higher percentage than that reported in whites.

Topics: Adolescent; Adult; Aged; Antihypertensive Agents; China; Cloprostenol; Dose-Response Relationship, Drug; Double-Blind Method; Eye Color; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Incidence; Iris; Iris Diseases; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prognosis; Prospective Studies; Travoprost; Young Adult

To compare the efficacy of brimonidine, dorzolamide, and brinzolamide in reducing intraocular pressure (IOP) when used as adjunctive therapy to a prostaglandin analog (PGA).. Randomized, controlled, investigator-masked, single-site, parallel-group clinical trial.. One hundred twenty eyes of 120 patients with open-angle glaucoma or ocular hypertension who had inadequate IOP control after at least 6 weeks of monotherapy with a once-daily PGA (bimatoprost, latanoprost, or travoprost).. Study eyes were assigned randomly to adjunctive treatment with thrice-daily brimonidine tartrate 0.15% (n = 41), dorzolamide hydrochloride 2% (n = 40), or brinzolamide 1% (n = 39) for 4 months.. Efficacy was evaluated by IOP measured at 10 am and 4 pm at baseline, month 1, and month 4.. The mean IOP at each hour at PGA-treated baseline was comparable among treatment groups. After initiation of adjunctive therapy, the mean IOP was lower and the mean change from baseline IOP was greater in the brimonidine group than in either the dorzolamide group or the brinzolamide group at 10 am and 4 pm at months 1 and 4 (P<0.001). After 4 months of adjunctive treatment, the mean IOP reduction from baseline at 10 am and 4 pm was 4.8 mmHg (21%) and 3.8 mmHg (19%) with brimonidine, 3.4 mmHg (16%) and 2.8 mmHg (14%) with dorzolamide, and 3.4 mmHg (16%) and 2.6 mmHg (13%) with brinzolamide (P<0.001 for brimonidine vs. dorzolamide and brinzolamide at each time point). Each of the study drugs was well tolerated, and all patients completed the study.. The addition of brimonidine to a PGA provided greater IOP lowering than the addition of either dorzolamide or brinzolamide. Further studies are needed to evaluate the relative long-term efficacy and tolerability of these medications as adjunctive therapy to a PGA.. Proprietary or commercial disclosure may be found after the references.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Quinoxalines; Single-Blind Method; Sulfonamides; Thiazines; Thiophenes; Tonometry, Ocular; Travoprost; Treatment Outcome

To assess the usefulness and tolerability of systematically switching glaucoma patients from latanoprost 0.005% and timolol 0.5% (Lat + Tim) to a fixed combination of travoprost 0.004%/timolol 0.5% (TTFC), and to record the effects of this switch on tear-film break-up time (TBUT).. Intraocular pressure (IOP) reduction, patients reaching IOP < 18 mmHg; the rate of discontinuation; TBUT; and the onset of adverse events (AEs).. Multicenter, observational cohort, 6-month study: 309 patients on concomitant Lat + Tim were switched to TTFC (evening dosage). IOP, TBUT, and AEs were recorded at baseline and after 1 and 6 months.. IOP was significantly decreased (from 18.3 +/- 2.9 to 16.6 +/- 2.7 mmHg) after substitution (p < 0.0001). Many patients (82%) reached an IOP < 18 mmHg (p < 0.0001). TBUT improved significantly (from 8.4 +/- 3.6 to 9.2 +/- 3.8 s, p < 0.0001). A few patients reported AEs (8.7%), which caused discontinuation in a low percentage (4.5%).. TTFC appeared useful in this selected population. In this study, patients who underwent a regimen modification to TTFC obtained further reduction in IOP with a lower exposition to preservative toxicity. The low discontinuation rate at 6 months indicates a good tolerability profile.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cohort Studies; Drug Combinations; Drug Therapy, Combination; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Tears; Time Factors; Timolol; Travoprost

The aim of the study was to compare the efficacy of travoprost 0.004% eye drops added to therapy with timolol 0.5%. The study included 40 patients (80 eyes) with open angle glaucoma and intraocular pressure (IOP) above 18 mm Hg treated with topical beta blocker (timolol 0.50% twice a day). Travoprost 0.004% was added to timolol 0.5% therapy once daily in the evening. Follow up examinations were scheduled at 7 days, one month and three months. IOP lowering was achieved in all patients. Substantial lowering of 2.42 mm Hg was achieved after the first week of treatment. Further lowering and stabilization of IOP was recorded at three months, with total IOP decrease of 3.97 mm Hg; the difference was statistically significant (chi2=6.7743; p<0.01). At three months, target IOP was recorded in 64 eyes (16.4+/-0.7 mm Hg) and failed to be achieved in 16 eyes (21.1+/-2.3 mm Hg). Mild hyperemia was found in two patients and discrete hyperemia in 26 patients. Burning sensation associated with the use of travoprost 0.004% eye drops was reported by 68 patients. In conclusion, the use of travoprost 0.004% eye drops resulted in successful lowering of IOP and achievement of target IOP.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Timolol; Travoprost

To evaluate the effect of long-term application of bimatoprost and latanoprost on the anterior chamber depth of primary open-angle glaucoma patients.. The anterior chamber depth (ACD) and axial length (AL) of patients using prostaglandin analogues for open-angle glaucoma (group I) and an age- and gender-adjusted control group (group II) were measured by ultrasonography. Patients using bimatoprost and those using latanoprost were also compared in terms of ACD and AL.. The mean ACD of group I (27 eyes of 27 subjects) was significantly lower than that of group II (30 eyes of 30 subjects) (p = .012). Similarly, the ratio of ACD to AL was significantly lower in group I compared with group II (p = .001). The ACDs of patients using bimatoprost or latanoprost and the control group were not significantly different by Kruskal-Wallis test (p = .056), but the differences of these 3 groups in ACD/AL ratios were significant (p = .004). When the Mann Whitney U test was used for pairwise comparison, there was a significant difference between the control group and the patients using latanoprost or bimatoprost in terms of the ACD/AL ratio (p = .008 for each). There was no difference between the patients using latanoprost and those using bimatoprost in terms of the ACD/AL ratio (p = .4).. The ACD of patients on prolonged therapy with prostaglandin analogues seems to be lower than than that of the control group. However, prospective long-term studies on large number of subjects are needed to evaluate the effect of each type of prostaglandin on ocular structures.

Topics: Adult; Aged; Amides; Anterior Chamber; Bimatoprost; Cloprostenol; Cross-Sectional Studies; Dose-Response Relationship, Drug; Female; Glaucoma, Open-Angle; Humans; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Statistics, Nonparametric; Time Factors; Treatment Outcome; Ultrasonography

Bimatoprost and the fixed combination of latanoprost with timolol maleate are 2 medications widely used to treat glaucoma and ocular hypertension (OHT). The aim of the study is to compare the efficacy of these 2 drugs in reducing intraocular pressure (IOP) after 8 weeks of treatment in patients with primary open angle glaucoma (POAG) or OHT.. In this randomized, open-label trial, 44 patients with POAG or OHT were allocated to receive either bimatoprost (1 drop QD) or latanoprost/timolol (1 drop QD). Primary outcome was the mean diurnal IOP measurement at the 8th week, calculated as the mean IOP measurements taken at 8:00 am, 10:00 am, and 12:00 pm Secondary outcomes included the baseline change in IOP measured 3 times a day, after the water-drinking test (performed after the last IOP measurement), and the assessment of side effects of each therapy.. The mean IOP levels of latanoprost/timolol (13.83, SD = 2.54) was significantly lower than of bimatoprost (16.16, SD = 3.28; P < 0.0001) at week 8. Also, the change in mean IOP values was significantly higher in the latanoprost/timolol group at 10:00 am (P = 0.013) and 12:00 pm (P = 0.01), but not at 8:00 am (P = ns). During the water-drinking test, there was no significant difference in IOP increase (absolute and percentage) between groups; however, there was a significant decrease in mean heart rate in the latanoprost/timolol group. Finally, no significant changes in blood pressure and lung spirometry were observed in either groups.. The fixed combination of latanoprost/timolol was significantly superior to bimatoprost alone in reducing IOP in patients with POAG or OHT. Further studies with large sample sizes should be taken to support the superior efficacy of latanoprost/timolol, as well as to better assess its profile of side effects.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Blood Pressure; Cloprostenol; Drug Combinations; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Timolol

The aim of this study was to evaluate the intraocular pressure (IOP) efficacy and safety of dorzolamide/timolol in fixed combination (DTFC) versus bimatoprost in open-angle glaucoma (OAG) patients poorly controlled (> or =21 mmHg) on latanoprost.. This was a prospective, double-masked, randomized, controlled, cross-over evaluation. After a 6-week wash-out period, the patients then returned for baseline diurnal curve testing every 2 h (8 AM to 8 PM). Patients with an IOP of 22-29 mmHg inclusive at 8 AMwere randomized to either bimatoprost dosed each evening or DTFC twice-daily. Patients returned in 8 weeks for the Period 1 diurnal curve and were switched to the opposite treatment. Patients again returned in 8 weeks for the Period 2 diurnal curve.. Of the 29 patients, mean untreated baseline IOP (visit 2) was 24.6 +/- 2.6 mmHg and treatment mean IOP was statistically lower with bimatoprost 17.6 +/- 2.0 mmHg than for DTFC 18.8 +/- 2.5 mmHg (P = 0.03), as was the IOP range (P = 0.02) and IOP peak (P = 0.003). No significant differences were found between DTFC and bimatoprost at individual time points after a modified Bonferroni correction (>0.02). DTFC demonstrated a greater incidence of stinging or burning (n = 12) than bimatoprost (n = 0; P = < 0.0001).. This study suggests that OAG patients generally can obtain similar IOP control at individual time points (when a Bonferroni correction is considered) by switching to either DTFC or bimatoprost, but overall diurnal control is statistically better with bimatoprost.

Topics: Aged; Aged, 80 and over; Amides; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Timolol

To compare intraocular pressure (IOP) lowering efficacy of bimatoprost 0.03% / timolol 0.5% fixed combination (BTFC) and other combinations of glaucoma drugs (bimatoprost, latanoprost 0.005% / timolol 0.5% fixed combination, separate use of travoprost 0.004 % and timolol 0.5 %) in patients with glaucoma.. Fifty-three patients with glaucoma were divided into 3 groups according to their original glaucoma therapy. BTFC was used by the patients for a period of 3 months. After 1 week, 1, 2 and 3 months, the diurnal IOP curves were performed. Side effects of the new treatment were recorded and compared to the original therapy.. The mean diurnal IOP reduction in the group of patients switching from bimatoprost to BTFK reached 4.4 +/- 2.28 mm Hg (p < 0.01). In the group of patients initially on latanoprost / timolol fixed combination, the IOP decreased with BTFK by 2.3 +/- 1.5 mm Hg (p < 0.01). Changing therapy from travoprost / timolol seperate combination to BTFK caused an IOP decrease by 2.3 +/- 1.5 mm Hg on average (p < 0.01). Conjunctival hyperemia with initial therapy was experienced in 33% of patients in our study group. With BTFK application, the hyperemia improved in 69% of these patients, got worse in 12.5% and remained unchanged in 19% of the patients. Patients found the BTFK better than the original medication in 37.5% of cases, the same in 52% and worse in 10.5%. Five patients terminated the study earlier due to poor IOP compensation or marked side effects of BTFK.. In all three groups of glaucoma patients there was a significant and prolonged decrease in IOP after treatment with BTFK. The use of BTFK was accompanied by smaller incidence of conjunctival hyperemia compared to isolated bimatoprost or travoprost / timolol combination.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ocular Hypotension; Prostaglandins F, Synthetic; Timolol; Travoprost

To compare the IOP-lowering efficacy of a.m.-dosed travoprost and latanoprost at 24-h post-dose.. Open-angle glaucoma patients not naïve to prostaglandin therapy and currently controlled on p.m.-dosed (2100) latanoprost (n = 21) or travoprost (n = 30) had baseline IOPs measured at 0900. In a randomized, single-masked, crossover design, patients received travoprost (Travatan † ) or latanoprost (Xalatan ‡ ) at 0900 for 4 weeks, then were crossed over to receive the second prostaglandin for another 4 weeks. Treatment IOP was measured at 0900 prior to morning dose at both 4 and 8 week visits. Patient dosing preference (a.m./p.m.) was surveyed on exit.. Intraocular pressure (IOP). † Travatan is a registered trade name of Alcon Laboratories, Inc., Fort Worth, TX, USA ‡ Xalatan is a registered trade name of Pfizer, New York, NY, USA.. The mean IOP in the first period when all patients were dosed in the evening was assessed 12 h after dosing at 09:00 and it was similar in the two treatment groups (mean ± standard deviation: 17.9 ± 2.7 mmHg for travoprost versus 17.7 ± 2.5 mmHg for latanoprost, p = 0.812). In the a.m.-dosing crossover comparison, the 24-h post-dose IOP was significantly lower ( p < 0.001) on travoprost (16.9 ± 3.1 mmHg) compared to latanoprost (18.6 ± 3.3 mmHg). In the exit survey, 51% of patients preferred a.m.-dosing.. a.m.-dosed travoprost is superior to a.m.-dosed latanoprost by 1.7 mmHg at 24-h post-dose.

Topics: Aged; Aged, 80 and over; Algorithms; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Glaucoma, Open-Angle; Humans; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Single-Blind Method; Time Factors; Travoprost; Treatment Outcome

The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 hours after instillation.. Patients with ocular hypertension or primary open angle glaucoma stabilized on TT or TL were included in this retrospective cross-sectional study. Data on demographics, medical history and previous treatments were extracted from the patients' medical records. Last treatment instillation times and IOP values were recorded at clinic visits. Treatments were compared by analyses of variance, logistic regressions and propensity scores adjusted for confounding factors.. Out of 316 patients included, 124 instilled TT, 192 instilled TL and 266 (84.2%) overall had instilled their eye drops within 24 hours. The patients' mean age was 64.5 years and 51.6% were female. Treatment groups were comparable except for longer disease and treatment durations in TL recipients. Worse eye mean IOPs were 25.8 mmHg at diagnosis and 21.9 mmHg on starting their designated fixed combination treatment. The best IOP control was provided by TT instillations (mean IOP 17.1 and 19.0 mmHg in the TT and TL groups, respectively; p < 0.001). This difference was reinforced by results in the subgroup of patients who instilled treatment >24 hours prior to IOP measurement (mean IOP 17.0 and 20.3 mmHg in the TT and TL groups, respectively; p < 0.004). Also, 82.6% of TT patients satisfied their ophthalmologists' IOP targets versus 51.1% of TL patients (p < 0.001). All significant differences persisted after adjustment for confounding factors.. This study, conducted in routine ophthalmic practice, confirmed published clinical trial results showing that TT provides better IOP control than TL when measured in the morning, and that travoprost has longer-lasting residual effects than latanoprost when IOP is measured >24 hours after instillation. However, readers should interpret these findings in the context of a cross-sectional observational study conducted in a naturalistic setting.

Topics: Adult; Aged; Cloprostenol; Cross-Sectional Studies; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Retrospective Studies; Timolol; Travoprost

To evaluate the effects of topical latanoprost, travoprost, and bimatoprost on the blood-aqueous barrier and central corneal thickness (CCT) of patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).. Prospective, randomized, masked-observer, crossover clinical trial.. A total of 34 phakic patients with POAG or OHT with no previous history of intraocular surgery or uveitis completed the study. Patients were randomized to use latanoprost 0.005%, travoprost 0.004%, or bimatoprost 0.03% once daily (2000 hours) for 1 month, followed by a washout period of 4 weeks between each drug. Aqueous flare was measured with a laser flare metre. CCT was calculated as the average of five measurements using ultrasound pachymetry. All measurements were performed by a masked observer (1000 h).. There were no statistically significant differences between baseline mean IOP, mean CCT, and mean flare values among the groups. There was no statistically significant increase in mean flare values from baseline in all groups (P>0.05). There were no statistically significant differences between mean flare values among the groups (P>0.05). All medications significantly reduced the mean IOP from baseline (P<0.0001). IOP reduction obtained with travoprost (7.3+/-3.8 mmHg) was significantly higher than that obtained with latanoprost (4.7+/-4.2 mmHg) (P=0.01). A statistically significant reduction in mean CCT (0.6+/-1.3%) from baseline was observed when patients instilled bimatoprost (P=0.01).. Latanoprost, travoprost, and bimatoprost had no statistically significant effect on the blood-aqueous barrier of phakic patients with POAG or OHT. Bimatoprost may be associated with a clinically irrelevant reduction in mean CCT.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Blood-Aqueous Barrier; Cloprostenol; Epidemiologic Methods; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

To evaluate whether inter-visit intraocular pressure (IOP) range, which reflects extreme and potentially damaging IOP fluctuations, provides additional information on IOP control compared to mean IOP.. Post hoc analysis of Xalatan/Lumigan/Travatan study data, a masked-evaluator, randomized, parallel-group comparison of 12-week efficacy of latanoprost, bimatoprost, and travoprost in open-angle glaucoma/ocular hypertension patients.. Pretreatment inter-visit IOP range defined as highest IOP minus lowest IOP at screening, safety check, and baseline (six measurements); posttreatment inter-visit IOP range defined as highest IOP minus lowest IOP at weeks two, six, and 12 or early termination (nine measurements). Ranges dichotomized as "high" (>6 mm Hg) vs "low" (< or =6 mm Hg).. Included were 410 patients (latanoprost, 136; bimatoprost, 136; travoprost, 138). Each resulted in significant mean IOP range reductions during 12 weeks. Pretreatment inter-visit IOP range was associated with African-American race, male gender, and presence of visual field defect (P < .05 for all). Percentages with high pretreatment inter-visit IOP ranges were comparable across treatments (63% to 64%). High posttreatment inter-visit IOP range was seen in 21% (28/136), 28% (38/136), and 36% (50/138) of latanoprost, bimatoprost, and travoprost groups, respectively (P = .016, overall; P = .005, latanoprost vs travoprost). High posttreatment inter-visit IOP range was associated with African-American race, high pretreatment inter-visit IOP range, and treatment with travoprost vs latanoprost (P < .05 for all).. Given that high inter-visit IOP range is associated with risk factors for glaucomatous damage and that such differences cannot be evaluated using mean IOPs, inter-visit IOP range may be another useful approach to assessing IOP control in clinical trials.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Office Visits; Ophthalmic Solutions; Prostaglandins F, Synthetic; Risk Factors; Travoprost; Treatment Outcome

To compare circadian control of intraocular pressure (IOP) after a single drop of bimatoprost 0.03% or travoprost 0.004% in patients with glaucoma or ocular hypertension.. Randomized, investigator-masked, paired-eye, 36-hour clinical comparison. After completing a washout, patients (N = 19) were randomized to a single drop of bimatoprost in one eye and travoprost in the other eye at 8 PM. At night, IOP was measured with patients lying in bed and sitting. IOP was measured every 4 h for 36 h in total.. Mean IOP at 8 PM (prior to drop instillation) was 20.6 mmHg (18.5-24.0 mmHg) with the bimatoprost eye group and 21.1 mmHg (18.5-26.5 mmHg) with the travoprost eye group (p = 0.369). At every measurement, both bimatoprost and travoprost significantly reduced IOP from baseline. During the first 24 h, mean IOP (while sitting) after instillation of a single drop of study medication ranged from 17.8 to 19.7 mmHg with bimatoprost and from 17.2 to 20.0 mmHg with travoprost (p > or = 0.075). While in the supine position, IOP ranged from 21.6 to 24.9 mmHg with bimatoprost and from 21.1 to 25.2 mmHg with travoprost (p > or = 0.351). Both medications continued to control IOP for the remaining 12 h, with IOP approaching baseline after 36 h (mean IOP of 20.5 mmHg with bimatoprost and 21.5 mmHg with travoprost, p = 0.381). Study limitations included single-drop instillation and a short follow-up time.. This marks the first time a single drop has been used for this type of evaluation. These findings suggest that both bimatoprost and travoprost provide comparable and lasting control of circadian IOP in patients with glaucoma or ocular hypertension.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Travoprost; Treatment Outcome

To compare the subjective symptoms, conjunctival hyperemia, tearing response and conjunctival cytological changes secondary to topical administration of bimatoprost and travoprost for 6 months.. Newly diagnosed primary open-angle glaucoma patients were randomly prescribed bimatoprost (35 cases) or travoprost (42 cases). Two patients in each group were excluded because they did not appear at their appointments regularly. Thus, 33 and 40 patients completed the study in the bimatoprost and travoprost groups, respectively. Redness, itching, foreign-body sensation, pain and discomfort were assessed by a questionnaire, and patients were examined for conjunctival hyperemia. Schirmer's I and break-up time tests were performed, and impression cytology of conjunctiva was evaluated.. Subjective symptoms were similar in both groups. The only subjective symptom that changed significantly was redness. The change in conjunctival hyperemia along the study period correlated with the patient-reported redness in both groups, being highest on day 30. Schirmer's test I and break-up time did not change with time and were similar in both groups. The impression cytology grade increased with time in both groups with the only significant difference between groups on day 90 (higher in the bimatoprost group).. We observed conjunctival hyperemia as the most common side effect of bimatoprost and travoprost. Tear film functions were not affected by these drugs while cytological alterations were.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Hyperemia; Male; Middle Aged; Ophthalmic Solutions; Prognosis; Risk Factors; Single-Blind Method; Travoprost

Prostaglandin analogs reduce intraocular pressure (IOP) by activation of matrixmetalloproteinase enzymes (MMP) and increasing uveoscleral outflow. MMP's were found in cornea and their activation could change the central corneal thickness (CCT).. To compare the effects of different prostaglandin analogues on central corneal thickness (CCT).. Clinical, observational, prospectively and randomised study during 3 month on 26 patients (52 eyes) newly diagnosed with primary open angle glaucoma or ocular hypertension. The patients were distributed in two groups concerning topical treatment: - group I: 15 patients treat with travoprost 0,004%; - group II: 11 patients treat with latanoprost 0,005%. The treatment was administrated daily at 9:00 pm, one drop. The CCT was measured for each patient for 3 times by ultrasound pachimetry: at the beginning of the study, at one month and three months. The groups were homogeneous concerning age and sex distribution. Exclusion criteria were: any topical eye drug usage, history of corneal disease or intraocular surgery. The statistic analyse was realised with Mann-Whitman test.. The mean central corneal thickness for the two groups was similar: 521,27+/-28,54 microm for group I and 522,18+/-27,52 microm for group II. A statistically significant CCT reduction was observed in both groups: 516,88+/-28,61 microm at one month and 515,04+/-27,59 microm at three month for group I; respectively 518,41+/-27,36 microm at one month and 517,98+/-27,86 microm at three month for group II.. The results of this study show that both classes of prostaglandin analogs reduce the mean CCT, the effect being equivalent for the both studied groups.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cornea; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome; Ultrasonography

To compare 6 months of treatment with bimatoprost and timolol in terms of their hypotensive efficacy and secondary effects, including changes in macular thickness and the inflammatory reaction induced in the anterior chamber.. A prospective, randomized, parallel-group trial performed on 30 eyes of 30 patients per group. The main outcome measure was the difference between the IOP value taken between the baseline visit and the 6-month-visit. Macular thickness determined through optical coherence tomography and anterior chamber inflammation estimated using the laser flare meter was also evaluated. Adverse events were recorded during the study period.. Bimatoprost treatment gave rise to a significantly lower mean IOP than timolol in all follow-up visits as from the first month (P<0.05). Bimatoprost achieved high percentage IOP reductions from baseline in a significantly higher proportion of patients (P<0.05). Macular thickness and anterior chamber flare failed to vary significantly both between the two groups and within each group during the 6-month evaluation (P>0.05).. Bimatoprost 0.03% once daily showed a greater efficacy then timolol 0.05% twice daily in patients with elevated IOP. No significant differences were detected in macular thickness or anterior uveitis using optical coherence tomography and laser flare photometry.

Topics: Adult; Amides; Anterior Chamber; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Macula Lutea; Ocular Hypertension; Prospective Studies; Timolol; Treatment Outcome

To evaluate 24-hour intraocular pressure (IOP) efficacy of latanoprost versus travoprost, each given every evening, in exfoliative glaucoma patients.. Prospective, observer-masked, crossover comparison.. Forty patients with exfoliation glaucoma.. Patients with a pressure of >24 mmHg were randomized to latanoprost or travoprost for an 8-week treatment period after a 6-week medicine-free period. Patients were then switched to the opposite treatment for the second period. At untreated baseline and at the end of each treatment period the IOP was measured at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am.. Diurnal IOP.. The mean 24-hour IOP was 25.1+/-2.5 mmHg at baseline, 17.8+/-2.1 mmHg on latanoprost, and 17.3+/-2.2 mmHg on travoprost (P = 0.001). Individual time points were similar between treatments, except at 6 pm when travoprost provided lower IOP (16.7+/-2.6 vs 17.9+/-2.5 mmHg, P<0.001). Adverse events showed more conjunctival hyperemia with travoprost (n = 15) than latanoprost (n = 6; P = 0.03).. Latanoprost and travoprost both significantly reduce the 24-hour IOP from baseline in exfoliative glaucoma, but travoprost may demonstrate a greater hypotensive efficacy in the late afternoon.

Topics: Aged; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Prospective Studies; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome; Visual Acuity; Visual Fields

To evaluate whether treatment with travoprost, an F2a prostaglandin analog, affects central corneal thickness (CCT) and whether intraocular pressure (IOP) response to the medication is related to baseline CCT.. This was a prospective, interventional, nonrandomized, nonconsecutive, clinical trial. In this multicenter study, 379 total patients, 220 with newly or previously diagnosed open-angle glaucoma (OAG), 141 with ocular hypertension (OHT), and 18 unspecified, were recruited from 15 Canadian sites. IOP and CCT assessments were performed at baseline and 6 weeks after treatment with travoprost. Patients on IOP-lowering therapy at the time of enrollment were washed out for 4 weeks before baseline examinations. IOP was measured with Goldmann tonometers and CCT with Accutome IV pachymeters. Statistical analysis was performed with S-PLUS software.. Posttherapy mean IOP decreased by 6.31 mm Hg or 24.4% (P < 0.001), and regression analysis indicated relatively greater IOP reduction in patients with higher pretherapy IOP (slope = 0.64; 95% CI, 0.54-0.76). Mean CCT decreased by 6.9 microm (P < 0.001). IOP reduction was not related to CCT reduction (slope = 0.253; 95% CI, -0.232 to 0.739; P = 0.305). Percent IOP decrease was not related to baseline CCT (slope = -0.02; 95% CI, -0.06 to 00.02; P = 0.33) in the total study sample. When OHT and OAG groups were considered separately, the OAG patients had less percent IOP decrease with thicker baseline CCT (slope = -0.067; 95% CI, -0.13 to -0.004; P = 0.037).. Treatment with travoprost decreased IOP significantly and was associated with CCT thinning, which had little or no effect on actual IOP decrease. In the OAG group, IOP decrease was found to be statistically smaller in patients with thicker corneas.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cornea; Diagnostic Techniques, Ophthalmological; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Tonometry, Ocular; Travoprost; Ultrasonography

To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension.. The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n=346), or travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3.. Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within +/-0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively.. Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Chemistry, Pharmaceutical; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Tonometry, Ocular; Travoprost; Treatment Outcome

To compare the ocular hypotensive efficacy and safety of topical bimatoprost and timolol-dorzolamide combination in patients with primary open-angle glaucoma (POAG) or ocular hypertension during 6 months of treatment.. A sample of 65 patients with a diagnosis of POAG or ocular hypertension were randomized to receive either bimatoprost 0.03% once daily or timolol-dorzolamide combination twice daily. Study visits occurred at baseline and after 2 weeks and 1, 3 and 6 months of therapy. Intraocular pressure (IOP) measurements were performed at 12.00 hours at all study visits and also at 08.00 hours and 16.00 hours at baseline and 6-month visits. At each visit, local and systemic side-effects that occurred during the treatment period were recorded. Student's t-test was used to compare the differences between IOP values.. Differences in IOP between the bimatoprost and timolol-dorzolamide groups were statistically insignificant at all study visits (p > 0.05). In the bimatoprost-treated group, the IOP reduction was 6.2 +/- 1.8 mmHg, whereas it was 6.5 +/- 2.3 mmHg in the timolol-dorzolamide group after 6 months of treatment. The difference was not statistically significant (p = 0.48).. The IOP-lowering efficacies of bimatoprost and timolol-dorzolamide combination were similar over a 6-month follow-up. Both bimatoprost and the timolol-dorzolamide combination were well tolerated. Bimatoprost can be used as a longterm monotherapy agent in the treatment of POAG and ocular hypertension.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Single-Blind Method; Sulfonamides; Thiophenes; Timolol

To compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.. Randomized, double-masked, multicenter clinical trial.. Two hundred patients with glaucoma or ocular hypertension.. Included were patients who were controlled (IOP < 21 mmHg) on the nonfixed combination of latanoprost and timolol for at least 3 months before the baseline visit or patients on monotherapy with either latanoprost or timolol who were eligible for dual therapy not being fully controlled on monotherapy. The latter group of patients underwent a 6-week wash-in phase with the nonfixed combination of latanoprost and timolol before baseline IOP determination and study inclusion. Supine and sitting position IOPs were recorded at 8 pm, midnight, 5 am, 8 am, noon, and 4 pm at baseline, week 6, and week 12 visits.. An analysis of covariance model was used for a noninferiority test of the primary efficacy variable, with mean area under the 24-hour IOP curve after 12 weeks of treatment as response variable and treatment, center, and baseline IOP as factors. A secondary analysis was performed on the within-treatment change from baseline.. Mean baseline IOPs were 16.3+/-3.3 mmHg and 15.5+/-2.9.mmHg in the bimatoprost and LTFC groups, respectively. At week 12, mean IOPs were 16.1+/-2.5 mmHg for the bimatoprost group and 16.3+/-3.7 mmHg for the LTFC group, and no significant difference between the 2 treatment groups could be found. As compared with baseline, mean IOP increased by 0.3+/-3.6 mmHg during the day and decreased by 0.8+/-3.8 mmHg during the night in the bimatoprost group, whereas there were increases of 1.43+/-2.6 mmHg and 0.14+/-3.2 mmHg in the LTFC group, respectively.. Bimatoprost is not inferior to the LTFC in maintaining IOP at a controlled level during a 24-hour period in patients switched from the nonfixed combination of latanoprost and timolol.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Treatment Outcome

To determine the mechanism by which travoprost 0.004% reduces intraocular pressure (IOP) in patients with ocular hypertension or primary open angle glaucoma.. This is a randomized, double-masked, placebo-controlled, single center study of 26 patients scheduled for 3 visits (baseline, day 15, and days 17 to 18) following screening.. After appropriate washout of all ocular medications, baseline IOPs were taken and travoprost 0.004% was administered once-daily in the evening for 17 consecutive doses to 1 eye and its vehicle to the fellow eye in a randomized, masked fashion. On day 15, beginning 12 hours after the 14th consecutive dose, IOP was measured by pneumatonometry, aqueous flow and outflow facility by fluorophotometry, and episcleral venous pressure by venomanometry. Uveoscleral outflow was determined by mathematical calculation. Two days later, the last drop of drug/vehicle was given at 2000 hours. Fluorophotometry and tonometry measurements were repeated between 2200 and 0600 hours. Treated eyes were compared with contralateral control eyes or baseline measurements, and daytime measurements were compared with nighttime measurements using paired t tests.. Travoprost-treated eyes showed a significant (P<0.001) decrease in daytime IOP compared with baseline (26%) or to vehicle-treated eyes (22%), and an increase in daytime outflow facility (P=0.001; 64%). The increase in uveoscleral outflow was not statistically significant. At night, the IOPs of travoprost-treated eyes remained 21% to 24% below baseline daytime values. Seated and supine IOPs in control eyes were significantly (P<0.04) lower at 2200 hours than 1700 hours (P<0.04). Supine IOPs were higher than seated IOPs in both control and treated eyes (P<0.001). Aqueous flow was significantly (P<0.001) reduced at night in both travoprost (30%) and vehicle-treated (25%) eyes when compared with daytime values. No other comparisons were statistically significant.. Travoprost seems to lower IOP by increasing trabecular outflow facility. An effect on uveoscleral outflow cannot be ruled out.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Aqueous Humor; Cloprostenol; Double-Blind Method; Female; Fluorophotometry; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Tonometry, Ocular; Travoprost

To compare efficacies of adjunctive therapy with brimonidine 0.15% and adjunctive therapy with brinzolamide 1% in combination with travoprost 0.004%.. Three-month randomized, parallel-group, double-masked, multicenter clinical trial.. Patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension with intraocular pressure (IOP) > 18 mmHg on monotherapy with travoprost (N = 163).. Patients were randomized to receive adjunctive therapy with twice-daily brimonidine (N = 79) or twice-daily brinzolamide (N = 84). Treatment efficacy was assessed after 1 and 3 months of combination therapy. Intraocular pressure was measured at 8 am, noon, and 4 pm at baseline (on travoprost monotherapy) and after 3 months of combination therapy. Mean diurnal IOP was defined as the average of the IOP measurements at these 3 time points. Adverse events were recorded at each visit.. Difference between treatment groups in mean diurnal IOP at month 3, adjusted for difference in baseline IOP, using analysis of covariance.. Mean diurnal IOPs (+/- standard error of the mean) at baseline were 21.7+/-0.33 mmHg in the brimonidine group and 21.1+/-0.29 mmHg in the brinzolamide group (P = 0.16). Mean diurnal IOPs at month 3 were 19.6+/-0.41 mmHg in the brimonidine group and 18.4+/-0.33 mm Hg in the brinzolamide group (P = 0.019). At month 3, mean diurnal IOPs, adjusted for difference in baseline IOP, were 19.3+/-0.27 in the brimonidine group and 18.6+/-0.25 in the brinzolamide group (P = 0.035).. The combination of travoprost and brinzolamide was statistically significantly more efficacious than the combination of travoprost and brimonidine in lowering IOP. The clinical significance of this difference is uncertain.

Topics: Adrenergic alpha-Agonists; Adult; Aged; Aged, 80 and over; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Circadian Rhythm; Cloprostenol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Quinoxalines; Sulfonamides; Thiazines; Travoprost; Treatment Outcome

To compare the efficacy and tolerability of a once daily evening dose of the latanoprost/timolol fixed combination (LTFC) with that of a once-daily evening dose of the bimatoprost/timolol fixed combination (BTFC) in patients with open-angle glaucoma with elevated intraocular pressure (IOP) insufficiently responsive to monotherapy with prostaglandin analogues/prostamides.. Prospective, randomized, evaluator masked, single-center study.. 36 patients with a diagnosis of open-angle glaucoma, with or without pseudoexfoliation, and inadequate control of IOP, insufficiently responsive to monotherapy with prostaglandin analogues/prostamides.. The primary end-points were the change in IOP at 9:00 am from baseline to week 4, and the difference between treatment groups in the mean diurnal IOP reduction from baseline to week 4.. BTFC provided significantly greater mean diurnal IOP reduction [mean (standard deviation)] 2.8 (0.9) mmHg, compared with LTFC 2.1 (0.6) mmHg, p = 0.0214. Both treatments significantly reduced the IOP from baseline at each IOP time-point measured, p < 0.0001, and for the mean diurnal IOP; p = 0.0049 for the LTFC, and p < 0.0001 for the BTFC. There were no significant differences in average hyperemia scores among groups, 1.25 (0.5) vs. 1.62 (0.69), p = 0.3835, for the LTFC and the BTFC, respectively.. The results of this study showed a significantly higher IOP-lowering effect of a once-daily evening dose of the BTFC compared to that of a once-daily evening administration of the LTFC.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Prostaglandins F, Synthetic; Single-Blind Method; Timolol; Treatment Outcome

To study the effect of three prostaglandin F(2)-alpha (PG) analogues on retrobulbar blood flow velocity in previously untreated patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), using colour Doppler ultrasound.. Sixty newly diagnosed patients with POAG or OHT were randomly assigned to travoprost 0.004% (n = 12 with POAG, n = 8 with OHT), latanoprost 0.005% (n = 11 with POAG, n = 9 with OHT) and bimatoprost 0.03% (n = 13 with POAG, n = 7 with OHT) treatment groups in a double-masked fashion. At baseline examination, blood pressure, heart rate and intraocular pressure (IOP) were recorded. Peak-systolic and end-diastolic velocities were measured in the ophthalmic (OA), central retinal (CRA) and temporal short posterior ciliary arteries (PCA). The resistive index (RI) and ocular perfusion pressure (OPP) were determined for each treatment group. After a treatment period of 6-months, all procedures were repeated.. There were no significant differences in age (53 +/- 14 years in the travoprost group, 51 +/- 14 years in the latanoprost group, 53 +/- 11 years in the bimatoprost group), gender (11 men, nine women; 11 men, nine women; 13 men, seven women, by group, respectively), or clinical diagnosis (POAG or OHT) among treatment groups (p > 0.05). A significant decrease in IOP (baseline: 26.4 +/- 3.3 mmHg, 26.8 +/- 1.3 mmHg, 25.8 +/- 1.8 mmHg, respectively; month 6: 20.9 +/- 1.9 mmHg, 20.8 +/- 2.4 mmHg, 18.3 +/- 1.2 mmHg, respectively; p < 0.0001) and an increase in OPP (baseline: 33.7 +/- 3.8 mmHg, 33.5 +/- 3.2 mmHg, 33.9 +/- 2.6 mmHg, respectively; month 6: 40.2 +/- 3.5 mmHg, 39.9 +/- 3.1 mmHg, 41.7 +/- 2.6 mmHg, respectively; p < 0.0001) were verified in all three groups during the study period. Mean baseline RI values for the CRA in the travoprost group and the OA in the latanoprost group were both 0.7 +/- 0.1 mmHg and both values were statistically significantly lower at 6 months (0.6 +/- 0.1 mmHg in both groups; p = 0.002, p < 0.0001, respectively). In the bimatoprost group there was no statistically significant difference in haemodynamic parameters over the study period (p > 0.05).. Our results suggest that the three PG analogues significantly reduce IOP and increase OPP in patients with POAG or OHT. Topical travoprost and latanoprost significantly reduce the RI of the CRA and OA, respectively. We were unable to determine any effect of topical bimatoprost on ocular haemodynamics.

Topics: Administration, Topical; Adult; Amides; Bimatoprost; Blood Flow Velocity; Ciliary Arteries; Cloprostenol; Double-Blind Method; Eye; Female; Glaucoma, Open-Angle; Hemodynamics; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Artery; Prostaglandins F, Synthetic; Regional Blood Flow; Retinal Artery; Travoprost; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Resistance

The aim of this study was to compare the long-term efficacy of bimatoprost 0.03% monotherapy in primary open angle glaucoma (POAG) versus primary chronic angle closure glaucoma (PCACG) eyes.. A total of 55 consecutive primary adult glaucoma patients on bimatoprost monotherapy were prospectively evaluated in this 3-year, open-labeled, uncontrolled study. The primary outcome was the evaluation of a difference in the response to therapy of POAG eyes, as compared to PCACG eyes over a follow-up of 3 years.. In the POAG group, the mean intraocular pressure (IOP) at the 36-month followup was found to be increased by 2.10 (+/-3.90) mmHg (confidence interval [CI], 0.975-4.185), compared to the mean IOP at 1 month (P = 0.047). In the PCACG group, the mean IOP at the 36-month follow-up was increased by 3.66) (+/- 3.34) mmHg (CI, 6.241-1.092), compared to the mean IOP at 1 month (P = 0.011). This upward drift in IOP was higher in the PCACG group, compared to the POAG group, but this was not statistically significant (P = 0.54). Patients with POAG and PCACG showed a 50% and 40% chance of having an IOP of <18 mmHg with bimatoprost monotherapy (P = 0.23), respectively, at the 3-year follow-up.. This study showed that bimatoprost 0.03% monotherapy significantly lowers IOP in both POAG and PCACG eyes over a period of 3 years, though its efficacy appeared to decrease over time, to a similar extent, in both groups.

Topics: Administration, Topical; Aged; Amides; Antihypertensive Agents; Bimatoprost; Chronic Disease; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Angle-Closure; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Prospective Studies; Time Factors

To assess the intraocular pressure lowering effect of travoprost 0.004% in previously treated and untreated open-angle glaucoma and ocular hypertensive patients.. This was a 3-month, multi-centre, open-label trial involving 1133 patients, conducted at 61 sites in Eastern Europe. Previously treated open-angle glaucoma or ocular hypertensive patients either had all or part of their existing therapy replaced with travoprost or had travoprost added to existing therapy, depending on the clinical judgment of the investigator. Untreated patients were also started on travoprost. In all patients travoprost was given once daily in the evening. Patients returned for follow-up visits at 1 and 3 months. The primary outcome variable was mean IOP change from baseline.. A total of 1,109 patients were available for analysis of efficacy; 731 used travoprost as replacement therapy (665 complete and 66 partial), 176 as adjunctive therapy; and 202 had not previously been treated. Mean IOP decreased by approximately 19-22% in replacement therapy patients; 26-29% in adjunctive therapy patients; and 27-30% in previously untreated patients. Replacement of beta-blocker monotherapy and latanoprost monotherapy by travoprost was accompanied by a 21-24% and 13-17% decrease in mean IOP respectively.. The results from this study support the concept that the majority of glaucoma patients, who are responding inadequately to other glaucoma therapies, could benefit from a change to travoprost monotherapy or from the addition of travoprost to their existing therapy.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Europe, Eastern; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Romania; Travoprost; Treatment Outcome

We evaluated the effect of long-term topical antiglaucoma drugs on the macula using the noninvasive macular visual field threshold test in 100 eyes of 75 patients with ocular hypertension or primary open-angle glaucoma. We found that topical antiglaucoma agents can alter macular sensitivity after long-term therapy and advise evaluation of the macula in glaucoma patients receiving antiglaucomatous agents.

Topics: Administration, Topical; Adult; Aged; Amides; Bimatoprost; Cloprostenol; Drug Administration Schedule; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Latanoprost; Lipids; Macula Lutea; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Travoprost; Visual Acuity; Visual Field Tests

The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).. This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination.. A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs that occurred with masked travoprost, latanoprost, and open-label travoprost were hyperemia (26.9%, 12.2%, and 5.3%, respectively), discomfort (3.2%, 3.4%, and 1.1%), and pruritus (4.5%, 2.0%, and 2.1%).. In this population of patients with OAG or OH, 6-week treatment with travoprost 0.004% was associated with a significantly greater decrease from baseline in pooled IOP compared with latanoprost 0.005% 20 hours after administration. There were no significant differences between the 2 groups. Travoprost and latanoprost were well tolerated.

Topics: Administration, Topical; Analysis of Variance; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

To compare 24-hour reduction in intraocular pressure (IOP) by latanoprost 0.005%, travoprost 0.004%, and bimatoprost 0.03% in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).. Randomized, double-masked, crossover study.. Twenty-four patients with POAG and 20 with OH.. Patients were treated with latanoprost, travoprost, and bimatoprost for 1 month. The treatment sequence was randomized, and washout lasted 30 days for each trial drug. Four 24-hour tonometric curves were recorded for each patient: 1 at baseline and 1 after each treatment period.. Intraocular pressure was measured at 3, 6, and 9 am; noon; 3, 6, and 9 pm; and midnight by 2 treatment-masked well-trained evaluators using a handheld electronic tonometer with the patient in supine and sitting positions and a Goldmann applanation tonometer with the patient sitting at the slit lamp. Supine systemic blood pressure was recorded at the same times. A randomized-blocks analysis of variance was used to analyze data.. All 3 drugs were highly effective in reducing IOP when compared to baseline. Mean IOP reductions were similar after the 3 prostaglandin analogs, and none of the differences among treatments reached statistical significance. The drugs' effect was significantly greater during the daytime (9 am-9 pm) than during the nighttime (midnight-6 am) with all prostaglandin analogs. In 7 of 44 patients (16%), nocturnal IOP was significantly higher than diurnal IOP, both at baseline and under the 3 prostaglandin analogs.. From a clinical point of view, the overall results seem to indicate that the 3 prostaglandin analogs are powerful agents in controlling round-the-clock IOP in POAG and OH patients.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Blood Pressure; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

To evaluate the quality of 24-hour intraocular pressure (IOP) control between morning- and evening-dosed travoprost in primary open-angle glaucoma patients.. Prospective, crossover, double-masked comparison.. After a 6-week medicine-free period, 33 patients were randomized to receive travoprost dosed in the morning or evening. After 8 weeks of treatment, a 24-hour IOP curve was performed at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am. Patients were then treated with the opposite dosing regimen for another 8 weeks, after which the 24-hour IOP curve was repeated.. Twenty-four-hour IOP.. The untreated mean 24-hour IOP was 23.6+/-2.0 mmHg. There were no differences for mean 24-hour IOP between the morning (17.5+/-1.9 mmHg) and evening (17.3+/-1.9 mmHg) dosings (P = 0.7). At 10 am, the evening dosing provided a statistically lower IOP (17.2+/-2.1 mmHg) than the morning dosing (19.1+/-2.5 mmHg) (P = 0.02). Evening dosing demonstrated a statistically lower 24-hour fluctuation of IOP (3.2+/-1.0 mmHg) than morning dosing (4.0+/-1.5 mmHg) (P = 0.01). Safety was similar, with conjunctival hyperemia being the most common adverse event (n = 9 [27% for morning dosing] and n = 11 [33% for evening dosing], P = 0.6).. This study suggests that both morning and evening dosings of travoprost provide effective 24-hour IOP reduction. However, the evening dosing of travoprost demonstrates slightly greater daytime efficacy, with a narrower range of 24-hour pressure.

Topics: Circadian Rhythm; Cloprostenol; Conjunctiva; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Eye; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Pruritus; Travoprost; Treatment Outcome

The objective of this study was to directly compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% eyedrops with the fixed combination of latanoprost 0.005%/timolol 0.5% eyedrops in patients with primary open-angle glaucoma or ocular hypertension.. This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. Adult subjects with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension were eligible to participate if their IOP was inadequately controlled with > or =4 weeks of beta-blocker monotherapy, as indicated by IOP of 22 to 36 mm Hg at 9 AM at screening. Patients were randomly assigned in a 1:1 ratio to receive placebo + travoprost or latanoprost/timolol + placebo. Patients in the travoprost group administered travoprost at 9 PM and placebo at 9 AM; patients in the latanoprost/timolol group administered latanoprost/timolol at 9 AM and placebo at 9 PM. IOP measurements were performed using Goldmann applanation tonometry at 9 AM and 5 PM at the week-2 and week-6 visits. Both volunteered and elicited reports of adverse events were collected; all patients who were randomized and received > or =1 dose of study drug were included in the safety analysis.. One hundred ten patients were randomized, of whom 106 patients were evaluable (travoprost, n = 50; latanoprost/timolol, n = 56). There were no statistically significant differences at baseline between the treatment groups, based on age group, sex, race, iris color, or diagnosis. Mean IOP values were not statistically different between groups at baseline or during treatment. In the pooled results for 9 Am assessment at weeks 2 and 6, mean (SEM) IOP reductions for travoprost and latanoprost/timolol were 7.0 (0.5) and 6.4 (0.5) mm Hg, respectively (P = NS). Adverse events related to therapy were mild in nature, and there were no statistically significant differences between the 2 treatment groups. The most frequently experienced adverse events in the travoprost group were ocular hyperemia (9.3%), foreign body sensation (5.6%), abnormal vision (1.9%), allergic reaction (1.9%), conjunctivitis (1.9%), dacryocystitis (1.9%), eye discharge (1.9%), eye pruritus (1.9%), lid edema (1.9%), lid erythema (1.9%), and tearing (1.9%). In the latanoprost/timolol group, the most frequently experienced adverse events were cataract (1.8%), dry eyes (1.8%), eye pruritus (1.8%), foreign body sensation (1.8%), and ocular hyperemia (1.8%).. Mean IOP changes from baseline for travoprost 0.004% and latanoprost 0.005%/timolol 0.5% fixed combination were not significantly different at follow-up in these patients. Both medications were well tolerated.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

To evaluate the efficacies of bimatoprost and travoprost for lowering of intraocular pressure (IOP) for the treatment of glaucoma and ocular hypertension.. Prospective, randomised, investigator-blinded, parallel-group clinical trial. After completing a washout of all glaucoma drugs, patients (n = 157) were randomised to bimatoprost or travoprost for 6 months. Visits were at baseline, 1 week, and 1, 3 and 6 months. IOP was measured at 09:00 h at each visit and also at 13:00 and 16:00 h at baseline and at 3 and 6 months.. No significant between-group differences were observed in IOP at baseline, at 09:00, 13:00 or 16:00 h (p> or =0.741). After 6 months, both drugs significantly reduced IOP at every time point (p< or =0.001). After 6 months, mean IOP reduction at 09:00 h was 7.1 mm Hg (27.9%) with bimatoprost (n = 76) and 5.7 mm Hg (23.3%) with travoprost (n = 81; p = 0.014). At 13:00 h, mean IOP reduction was 5.9 mm Hg with bimatoprost (25.3%) and 5.2 mm Hg (22.4%) with travoprost (p = 0.213). At 16:00 h, the mean IOP reduction was 5.3 mm Hg (22.5%) with bimatoprost and 4.5 mm Hg (18.9%; p = 0.207) with travoprost. Both study drugs were well tolerated, with ocular redness the most commonly reported adverse event in both treatment groups.. Bimatoprost provided greater mean IOP reductions than travoprost.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Chi-Square Distribution; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Travoprost; Treatment Outcome

To evaluate the efficacy of travoprost 0.004% and brinzolamide 1% combined therapy in patients unsuccessfully treated with a combination of timolol 0.5% and brinzolamide 1%.. The study was conducted in 30 adult patient with primary open angle glaucoma (14 men and 16 women, mean age 68.5 years) who required change in therapy. Intraocular pressure was measured at entry, and on day 15, 45 and 90 thereafter.. The initial mean intraocular pressure was 21.62 mm Hg. Therapy modification (travoprost 0.004% instead of timolol 0.5%), resulted in intraocular pressure reduction by 5.67 mm Hg on day 15, and by 6.37 mm Hg on days 45 and 90.. The study showed travoprost 0.004% combined with brinzolamide 1% to provide a statistically significant reduction (p < 0.001) in intraocular pressure in patients who could not been successfully treated with timolol 0.5% and brinzolamide 1%.

Topics: Adrenergic beta-Antagonists; Aged; Carbonic Anhydrase Inhibitors; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Sulfonamides; Thiazines; Timolol; Travoprost

The primary objective of this study was to determine if combined travoprost ophthalmic solution 0.004% and brinzolamide ophthalmic suspension 1% therapy is superior in lowering intraocular pressure (IOP) compared to travoprost monotherapy for patients with open angle glaucoma or ocular hypertension. The secondary objective was to measure the percentage of patients achieving IOP levels of 18 mmHg or less.. Single arm, open-label.. eighty-two patients with inadequate IOP control with travoprost monotherapy.. the addition of brinzolamide ophthalmic suspension 1% twice daily.. The primary endpoint was mean IOP reduction from baseline at 4 and 12 weeks. The percentage of patients who achieved IOP values

Topics: Adult; Aged; Aged, 80 and over; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Sulfonamides; Thiazines; Travoprost

The purpose of this study was to compare travoprost (TRAV; travoprost 0.004%) and the fixed-combination of dorzolamide/timolol (DTFC; dorzolamide 2.0%/timolol maleate 0.5%) ophthalmic solutions for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT).. This was a randomized single masked, study with parallel controls. The TRAV group (n = 29) dosed once daily at 9:00 PM while the DTFC group (n = 27) dosed twice daily at 9:00 AM and 9:00 PM. IOP was measured at baseline, and following 3 weeks and 6 weeks of treatment at 8:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM.. Mean average IOP reductions from baseline during the course of the day were 7.5 (32.7%) and 7.1 (30.7%) mmHg for TRAV and 4.8 (23.1%) and 4.5 (21.7%) mmHg for DTFC at 3 weeks and 6 weeks, respectively. The greater IOP reduction for patients receiving TRAV was statistically significant at both the 3 and 6 week visits when averaged across all four time points (p < 0.01). The two products were well-tolerated over the course of the 6 week study. Some factors such as taste perversion were reported more often in the DTFC group.. Travoprost monotherapy provided better efficacy in terms of IOP reduction and percentage of IOP reduction compared to dorzolamide 2.0%/timolol maleate 0.5% fixed combination.

Topics: Cloprostenol; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Single-Blind Method; Sulfonamides; Thiophenes; Timolol; Travoprost

To compare the intraocular pressure-lowering efficacy and safety of topical bimatoprost 0.03% with that of travoprost 0.004% for the treatment of black patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).. Multicenter, prospective, randomized, investigator-masked trial of 94 black patients previously diagnosed with OAG or OHT. All patients completed washout of ocular hypotensive medications before study participation. Patients were assigned to either once-daily bimatoprost 0.03% or once-daily travoprost 0.004% for 3 months.. The primary outcome measures were mean intraocular pressure (IOP), mean change from baseline IOP, and percentage of patients who reached a target IOP reduction. Secondary measures included ophthalmologic examination and adverse events.. Both bimatoprost and travoprost significantly lowered IOP at all study visits (p < 0.001). Bimatoprost provided mean IOP reductions from baseline that ranged from 6.8 mmHg to 7.8 mmHg (27% to 31%). Travoprost provided mean IOP reductions from baseline that ranged from 6.2 mmHg to 6.9 mmHg (25% to 28%). By month 3, 85% of participants in the bimatoprost group had a mean IOP reduction of at least 20%, compared with 68% of those in the travoprost group. Furthermore, 31.9% of those in the bimatoprost group had a mean IOP reduction of more than 40% at month 3 compared with 20.9% of those in the travoprost group. There were no significant differences in biomicroscopy, ophthalmoscopy, or visual acuity. Ocular redness was the most commonly reported adverse event in both treatment groups. No serious adverse events were reported.. Bimatoprost and travoprost each effectively lowered IOP in this population of black patients. More patients achieved clinically relevant IOP reductions with bimatoprost.

Topics: Administration, Topical; Aged; Amides; Bimatoprost; Black or African American; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmoscopy; Single-Blind Method; Travoprost; Treatment Outcome; Visual Acuity

This study describes patients' and physicians' perceptions of issues related to dosing adherence with topical therapies for lowering intraocular pressure before and after use of the travoprost dosing aid (Travatan Dosing Aid, Alcon Research Ltd., Fort Worth, Texas).. The study had an open-label, multicenter, single-treatment-arm design that included sequential patients with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension who were taking any prostaglandin analogue monotherapy. Ten participating physicians were chosen on the basis of factors such as their experience, qualifications, and previous clinical study participation. The study consisted of 2 visits: screening and week 4. Patients were asked to complete a survey about their medication adherence before study entry at the screening visit and at study exit during the week-4 visit. In addition, each physician was asked to complete an entry and exit survey on each patient as well as a survey to provide feedback on the travoprost dosing aid.. Of the 87 enrolled patients, 6 did not complete the exit survey; therefore, 81 patients were included in the intent-to-treat analysis. Mean (SD) age at enrollment was 65.4 (11.6) years; 61.7% (50/81) of the patients were women and 60.5% (49/81) were white. Most patients (96.3% [78/81]) had open-angle glaucoma. Participating physicians perceived that problems involving dosing and adherence were reduced after patients used the dosing aid. Physicians indicated that they would recommend continued use of the travoprost dosing aid for 91.3% (73/80) of patients. All 10 participating physicians said that they would recommend the dosing aid to patients in the future. Of the 81 patients, the majority (68.8% [55/80]) indicated that they would like to continue using the travoprost dosing aid. For 67.5% (54/80) of patients, dosing adherence as recorded by the travoprost dosing aid was >70%. The dosing lever (39.7% [31/78]) and the visual alarm (29.5% [23/78]) were the 2 most favored features of the dosing aid reported by all evaluable patients. The majority of patients (58.8% [47/80]) indicated that they were "relieved" or "very relieved" that the doctor was able to monitor when they dosed their medication; few (7.5% [6/80]) were "concerned" or "very concerned" that the doctor was able to monitor their dosing.. The travoprost dosing aid was perceived to be effective in reminding this group of patients to take their medication as prescribed. In this study, the device was well accepted by both patients and physicians.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Attitude to Health; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Ocular Hypertension; Physicians; Prostaglandins, Synthetic; Travoprost

To evaluate latanoprost versus bimatoprost given each evening over the 24-hour diurnal curve.. Double-masked, 2-center, crossover comparison.. Forty-two of 44 patients with primary open-angle glaucoma (POAG) completed the study.. Consecutive patients were not treated during a baseline 24-hour curve after a glaucoma medicine-free period. They then were randomized to either latanoprost or bimatoprost for a 7-week treatment period. Diurnal curve intraocular pressures (IOPs) were measured at treatment period end at 2 am, 6 am, 10 am, 2 pm, 6 pm, and 10 pm. After the first treatment period, patients were changed to the opposite medicine without a medicine-free period. Diurnal curve measurements were performed again at the end of the second 7-week treatment period.. The 24-hour diurnal IOP.. On the last day of treatment, mean 24-hour IOPs were 17.3+/-2.8 mmHg for latanoprost and 16.7+/-2.4 mmHg for bimatoprost (P = 0.01). The 6 pm individual time point for IOP was statistically lower for bimatoprost after a Bonferroni correction (P = 0.008). The largest IOP difference at any time point was 0.9 mmHg at 6 pm. The most common side effect was conjunctival hyperemia, which occurred less with latanoprost (n = 6) than with bimatoprost (n = 15) (P = 0.004). Two patients had their treatments discontinued while on bimatoprost, one due to conjunctival hyperemia and the other due to ocular intolerance.. This study indicates that the 24-hour diurnal IOP is statistically lower in POAG with bimatoprost, compared with latanoprost, among patients who tolerated bimatoprost. However, the IOP difference between groups was small and may not be clinically meaningful. In contrast, conjunctival hyperemia seems statistically greater with bimatoprost. The exact clinical importance of conjunctival hyperemia, if any, needs to be clarified further.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic

To investigate the effects of prostaglandin analogues on the blood-aqueous barrier and to evaluate the occurrence of cystoid macular edema in aphakic or pseudophakic patients with glaucoma.. In this randomized, masked-observer, 6-month clinical trial, patients with primary open-angle, pseudophakic, or aphakic glaucoma were treated once daily with bimatoprost (n = 16), latanoprost (n = 15), or travoprost (n = 17) or twice daily with unoprostone (n = 16) or lubricant drops (control group) (n = 16). Blood-aqueous barrier status, which was assessed using a laser flare meter; intraocular pressure; the occurrence of angiographic cystoid macular edema; and conjunctival hyperemia were evaluated.. Mean flare values were significantly higher in the bimatoprost, latanoprost, and travoprost groups throughout follow-up (P < .02). Four latanoprost-treated eyes, 1 bimatoprost-treated eye, and 1 travoprost-treated eye developed cystoid macular edema; all cases resolved after discontinuation of the prostaglandin analogue and treatment with topical diclofenac sodium. Mean intraocular pressure reductions after 6 months were higher for the latanoprost (26%), bimatoprost (28%), and travoprost (29%) groups than for the control (3%) and unoprostone (14%) groups (P< .05). Bimatoprost induced significantly higher hyperemia scores than latanoprost, unoprostone, and placebo (P< .01).. Bimatoprost, latanoprost, and travoprost use may lead to disruption of the blood-aqueous barrier in patients with pseudophakia and aphakia.

Topics: Aged; Amides; Antihypertensive Agents; Aphakia, Postcataract; Bimatoprost; Blood-Aqueous Barrier; Cloprostenol; Dinoprost; Female; Fluorescein Angiography; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Macular Edema; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Pseudophakia; Safety; Travoprost

Reduced choroidal perfusion is hypothesized to play a role in the pathogenesis of normal tension glaucoma. Thus the impact of antiglaucomatous eye drops on ocular perfusion has been the focus of recent research and the subject of intensive investigations. The present study investigates whether topically applied latanoprost or bimatoprost influence ocular perfusion in patients with normal tension glaucoma and compares these effects with that changes detected after the treatment with dorzolamide.. Ocular hemodynamics were assessed by color Doppler imaging (CDI) shortly before and after a one-month treatment with either latanoprost, bimatoprost or dorzolamide. Primary end-points of the study were peak systolic and end-diastolic blood flow velocities in the short posterior ciliary artery (SPCA) under the new therapy. Intraocular pressure (IOP) and additional perfusion parameters in the SPCA and other retrobulbar vessels were tracked as observational parameters. n = 42 patients with normal tension glaucoma were enrolled in the study.. Systolic and diastolic blood flow velocities in the SPCA showed no significant alteration after the treatment with latanoprost or bimatoprost. Dorzolamide lead to increase of peak systolic velocity. IOP was reduced by all three agents in a range reported in the literature.. Topically applied latanoprost and bimatoprost act in a hemodynamically neutral manner and have the capability to lower IOP even in patients with normal tension glaucoma and low initial IOP level. Dorzolamide accelerates blood flow in systole. None of the tested compounds has a negative impact on hemodynamics in the short posterior ciliary arteries.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Blood Flow Velocity; Ciliary Arteries; Cloprostenol; Eye; Glaucoma, Open-Angle; Hemodynamics; Humans; Intraocular Pressure; Latanoprost; Lipids; Ophthalmic Artery; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Regional Blood Flow; Retinal Artery; Single-Blind Method; Sulfonamides; Thiophenes; Ultrasonography, Doppler, Color

To evaluate the effect of the combination of bimatoprost and latanoprost on intraocular pressure (IOP) in primary open angle glaucoma (POAG).. An open label randomised clinical trial was conducted, which included 18 glaucomatous patients (36 eyes). In the first 4 weeks, latanoprost 0.005% was prescribed for both eyes of the patients and any other antiglaucoma medication was discontinued. In the next 4 weeks (phase 1), bimatoprost 0.03% was combined with latanoprost in one randomly assigned eye (case eye) of each patient. In the next 4 weeks (phase 2), bimatoprost was discontinued in the case eyes, while bimatoprost was substituted for latanoprost in the fellow eye (control eye). The IOP was measured at the end of the first 4 weeks (baseline measurement) and weekly during phases 1 and 2.. In the case eyes, the mean IOP increased along the first phase (1.8 mm Hg; p = 0.006) when compared to baseline measurements. The IOP returned to previous values after discontinuation of bimatoprost in phase 2. In the control eyes, the mean IOP did not change throughout the study.. The combination of bimatoprost and latanoprost in POAG increases the IOP and should not be considered as a therapeutic option.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Prostaglandins F, Synthetic; Treatment Outcome

To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension.. Randomized multicenter, double-masked, active-controlled, parallel group study.. Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months.. Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone.. Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Travoprost; Treatment Outcome

To compare the efficacy of a fixed combination of travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months.. Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial.. Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer.. Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with travoprost/timolol combination and concomitant travoprost + timolol, respectively.. Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant travoprost + timolol. This study demonstrates that the fixed combination of travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.

Topics: Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Safety; Timolol; Travoprost; Treatment Outcome

The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of travoprost 0.004% (TRAVATAN) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertension.. This was a randomized, multicenter, double-masked, active-controlled, parallel group study. Three hundred sixteen patients with open angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.004%/timolol 0.5% ophthalmic solution fixed combination once daily in the morning or concomitant administration of timolol 0.5% once daily in the morning and travoprost 0.004% ophthalmic solution once daily in the evening. The efficacy and safety of the fixed combination were compared with concomitant therapy over three months. The primary efficacy outcome measure was mean intraocular pressure.. Both travoprost 0.004%/timolol 0.5% fixed combination and the concomitant administration of travoprost 0.004% and timolol 0.5% produced statistically significant reductions from baseline in IOP, with mean IOP ranging from 15.2 to 16.5 mm Hg in the patients using travoprost 0.004%/timolol 0.5% fixed combination compared with 14.7 to 16.1 mm Hg in the concomitant group. The upper 95.1% confidence limit for the differences in mean IOP (fixed combination minus concomitant) was < or =1.5 mm Hg at 7 of 9 visits, including all three 8 AM time points, 24-hours post-dose. Mean IOP reductions from baseline ranged from 7.4 to 9.4 mm Hg in the fixed combination group compared with 8.4 to 9.4 mm Hg with concomitant therapy. Safety analysis demonstrated equivalent safety between the two treatment groups.. A fixed combination of travoprost 0.004% and timolol 0.5% produced clinically relevant IOP reductions in patients with open angle glaucoma or ocular hypertension that were comparable to concomitant therapy with its components. Safety and tolerability of the fixed combination were also equivalent to concomitant therapy. Travoprost 0.004%/timolol 0.5% fixed combination offers IOP reduction equivalent to concomitant therapy, with potential benefits that include convenience (fewer bottles and drops per day), improved compliance, cost savings (based on fewer co-payments), and elimination of potential washout effects.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Timolol; Travoprost; Treatment Outcome

To investigate the influence of switching to travoprost on intraocular pressure (IOP) of chronic open-angle glaucoma (COAG) patients.. Multicentre, open-label, non-comparative, 12-week, phase IV study conducted at 10 academic and hospital centres in Hungary. Patients' compliance to use of the pre-study medication was confirmed at a visit 10 days before the baseline measurements, and compliance was monitored throughout the study period.. Of the 203 COAG patients three (1.48%) ceased travoprost medication due to ocular hyperaemia, and one subject was lost from follow-up. Self-reported compliance was optimal except for two patients. For the per-protocol analysis 197 patients were evaluable. IOP of the 37 per-protocol patients receiving additional travoprost medication decreased from 23.1 +/- 3.2 mmHg (mean +/- SD) to 17.3 +/- 2.6 mmHg at week 12 (p < 0.001). Switching the 121 per-protocol patients from latanoprost to travoprost IOP decrease from 20.8 +/- 3.5 mmHg to 17.7 +/- 2.4 mmHg (p < 0.001). IOP of the 11 patients switched from topical nonselective beta-blockers to travoprost decreased from 20.1 +/- 2.1 mmHg to 15.7 +/- 1.5 mmHg (p < 0.001). For the whole per-protocol population (n = 197) IOP decreased from 21.0 +/- 3.4 mmHg to 17.4 +/- 2.4 mmHg (p < 0.001). Defining responders as having an IOP decrease > 2.0 mmHg or >or= 5 mmHg at week 12, the responder rate was respectively 62.9% or 31% for the total study population; 86.5% or 54.1% when travoprost was added to the established therapy; 54.5% or 24.0% if latanoprost was switched to travoprost; and 90.9% or 36.4% for those who switched from beta-blockers.. Travoprost provided a clinically and statistically significant IOP decrease in uncontrolled COAG patients whose self-reported compliance to their previous topical medication was optimal. Our results suggest that the IOP reduction found after switching to travoprost is not explainable by improved compliance due to the clinical study situation.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Chronic Disease; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Patient Compliance; Travoprost

To analyse comparatively the efficacy and tolerance of latanoprost, travoprost and the fixed combination timolol-dorzolamide in the treatment of primary open angle glaucoma and ocular hypertension.. Prospective, investigator masked, randomized study that included 38 patients (38 eyes) with primary open angle glaucoma uncontrolled under beta blockers. Each patient received latanoprost, travoprost and the fixed combination timolol-dorzolamide (for 3 months each). The first drug and the order of the next drugs administered were randomized. The follow up period was 9 months. At the baseline and at the end of each therapeutic period (3 months) we determined the IOP (at 8, 10 a.m. and 4 p.m.), visual acuity, C/D ratio, blood pressure, heart rate and local tolerance. We have also photographed the eyelids, lashes, conjunctiva and iris. After each month of treatment we determined the IOP (at 8 and 10 am), visual acuity, blood pressure, heart rate and local tolerance.. The mean initial IOP was 25.1 2.89 mmHg and after 9 months of treatment 21.67 4.59 mmHg. Each drug induced a statistically significant IOP decrease (the fixed combination timolol-dorzolamide decreased IOP with 14.33%, travoprost with 18.39% and latanoprost with 22.1%). The IOP lowering was comparable for the prostaglandin derivatives and superior to the fixed combination timolol-dorzolamide. None of these drugs had a negative influence on the visual field, C/D ratio, visual acuity, blood pressure and heart rate. There was good local tolerance. The side effects were more frequent after travoprost (37) and latanoprost (22) than after the fixed combination timolol-dorzolamide (4 cases). The most important adverse events for the prostaglandin derivatives were conjunctival hyperemia, eyelashes pigmentation and growth, iris pigmentation. There was no necessary to stop the medication because of these effects.. Travoprost, latanoprost and the fixed combination timolol-dorzolamide are efficient in the treatment of primary open angle glaucoma. The prostaglandin derivatives determined similar IOP decrease, which was superior to the fixed combination timolol-dorzolamide; the local tolerance was good, the fixed combination causing the fewest side effects.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Glaucoma, Open-Angle; Humans; Latanoprost; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Timolol; Travoprost; Treatment Outcome

To observe the possible correlations between the hypotensive effect of the prostaglandin analogs and the axial length of the ocular globe.. A prospective, observational and randomized study (one year) on 27 patients with POAG treated by prostaglandin analogs monotherapy. The patients have been divided in two groups according to the type of the prostaglandin analogs used: group A - 12 patients - travoprost 0,004 % (Travatan) and group B - 15 patients - latanoprost 0,005 % (Xalatan). The IOP and the axial length have been evaluated at the beginning of the study and at 1, 3, 6, 9, 12 months using Goldmann aplanotonometry and echo-biometry. The results have been statistically analyzed using the Wilcoxon test.. The mean IOP reduction was similar in both groups, without statistically significant differences. Between the IOP reductions and the axial length of the ocular globe were demonstrated significant correlations according to the patients distribution on the echo-biometry results.. The IOP reduction with prostaglandin analogs monotherapy may also depend of the axial length of the ocular globe.

Topics: Antihypertensive Agents; Cloprostenol; Drug Therapy, Combination; Eye; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Prospective Studies; Prostaglandins F, Synthetic; Romania; Statistics, Nonparametric; Travoprost; Treatment Outcome; Ultrasonography

Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily.. A pilot study was conducted to evaluate the duration of travoprost's IOP-lowering efficacy up to 84 hours after the final dose in patients with open-angle glaucoma. A follow-up study was conducted to compare diurnal IOP control with travoprost and latanoprost over a 44-hour period.. In the open label pilot study, patients received 0.004% travoprost in both eyes at 8 pm daily for 2 weeks. After 2 weeks, IOP was measured before administration of the last daily dose, every 4 hours thereafter for 36 hours, and 60 and 84 hours after the last dose, with no additional ocular hypotensive medication given. In the controlled, double-masked, parallel-group, follow-up study, patients were randomized to self-administer 1 drop of the marketed doses of 0.004% travoprost or 0.005% latanoprost in both eyes at 8 pm daily for 2 weeks. At the end of this period, patients returned to the facility at approximately 8 pm for IOP measurement and administration of the final dose of study medication. IOP was then measured at 4-hour intervals for 44 hours after the last dose, with no additional ocular hypotensive medication given.. The pilot study included 21 patients (67% female, 33% male; age range, 35-81 years) with open-angle glaucoma. IOP values were significantly below baseline at all time points up to 84 hours after the final dose of travoprost ( P<0.001). The follow-up study enrolled 35 patients, 1 of whom was excluded for missing data; thus, the intent-to-treat analysis included 34 patients (68% female, 32% male; age range, 36-72 years). At the unmedicated eligibility visit, mean IOP over 24 hours ranged from 21 to 26 mm Hg in each treatment group. After 2 weeks of treatment and 24 hours after the last dose, mean (SD) IOP was 13.1 (2.1) mm Hg (change from eligibility visit, -10.4 [2.7] mm Hg) in the travoprost group and 16.0 (3.1) mm Hg (change from eligibility visit, -7.1 [2.4] mm Hg) in the latanoprost group. The difference in change from baseline was statistically significant between treatment groups (P=0.006). Travoprost lowered IOP significantly at all time points throughout the 44-hour period after the last dose (mean IOP,

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Double-Blind Method; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Latanoprost; Male; Middle Aged; Pilot Projects; Prostaglandins F, Synthetic; Travoprost

To evaluate the IOP-lowering efficacy of bimatoprost and travoprost for the treatment of glaucoma and ocular hypertension.. Randomized, investigator-masked, parallel-group clinical trial. After completing a washout from all glaucoma medications, patients (n=26) were randomized to bimatoprost or travoprost for 6 months. Visits were at baseline, week 1, and months 1, 3, and 6. IOP was measured at 9 am at each visit and also at 1 and 4 pm at baseline and months 3 and 6.. At the baseline visit, there were no significant between-group differences in IOP at 9 am, 1 pm, or 4 pm (P> or =.776). After 6 months of therapy, both medications provided significant mean reductions from baseline IOP at every time point (P< or =.007). Mean IOP reductions ranged from 7.4 mm Hg to 8.8 mm Hg (34% to 36%) with bimatoprost and from 4.6 mm Hg to 7.2 mm Hg (19% to 29%) with travoprost (P> or =.057) after 6 months of medication. At the final study visit, more patients achieved low target pressures with bimatoprost than with travoprost at each time point. Both study medications were well tolerated and ocular redness was the most commonly reported adverse event in both treatment groups.. Although both bimatoprost and travoprost effectively lowered IOP in patients with glaucoma or ocular hypertension, bimatoprost provided larger mean IOP reductions than travoprost. More patients achieved low target pressures with bimatoprost than with travoprost. The between-group differences were not statistically significant due to the small sample size. These findings are being further evaluated in an ongoing multicenter clinical trial.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Evaluation; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Pilot Projects; Prospective Studies; Travoprost

In glaucoma and ocular hypertension, clinically relevant intraocular pressure lowering due to a new medication is frequently defined as at least a 15% or 20% reduction from baseline intraocular pressure. This report compares the percentages of treated patients achieving such reductions in intraocular pressure after 6 months of treatment with bimatoprost or latanoprost. In the previously published study (Noecker et al: A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Am J Ophthalmol 135:55-63, 2003), patients with glaucoma or ocular hypertension were randomly assigned to once-daily treatment with bimatoprost 0.03% (n=133) or latanoprost 0.005% (n=136), after washout of any previous glaucoma medications. The primary outcome measure of that study was mean change from baseline intraocular pressure. The secondary, post hoc analysis presented here compares the diurnal and long-term responder rates observed with bimatoprost and latanoprost patients. Diurnal responders were defined as patients who achieved at least a 15% or 20% reduction from baseline intraocular pressure at each of the three timepoints (8 am, 12 pm, and 4 pm) on a given visit. At week 1 and months 1, 3, and 6, in the bimatoprost group, 70.7-81.2% of patients achieved at least a 15% reduction in IOP at each timepoint, and 57.9-68.4% achieved at least a 20% reduction. Significantly fewer patients receiving latanoprost achieved a 15% or a 20% decrease in IOP at each timepoint: 48.5-61.8% of patients achieved at least a 15% decrease and 36.0-47.1% achieved at least a 20% decrease. (P< or =.007). The data presented here suggest that patients using bimatoprost are more likely than patients using latanoprost to achieve intraocular pressure reductions of at least 15% or 20% from baseline throughout the day.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic

To compare the efficacy and safety of once-daily (QD) bimatoprost, latanoprost, and timolol gel-forming solution in providing 24-hour intraocular pressure (IOP) control.. This was a randomized, multicenter, investigator-masked, prospective, parallel-group, clinical trial.. Patients with open-angle glaucoma or ocular hypertension.. After washout of any previous ocular hypotensive medications, patients were randomly assigned to treatment with bimatoprost 0.03% ophthalmic solution QD (n=38) or latanoprost 0.005% ophthalmic solution QD (n=38) between 7 and 9 pm, or timolol maleate 0.5% gel-forming ophthalmic solution QD (n=39) between 7 and 9 am for 1 month.. The primary outcome measure, circadian IOP, was measured at eight time points over the course of 24 hours beginning at 8 am on day 28 and with the last measurement at 8 am on day 29. IOP was also measured at 8 am and 10 am at baseline and at 8 am on day 14. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure.. At 10 am (peak drug effect) on day 28, the mean IOP reduction from baseline was significantly greater with bimatoprost (9.3 mm Hg, 40.3%) than with timolol gel (7.1 mm Hg, 31.1%; P=.024, Wilcoxon rank sum test) or latanoprost (7.4 mm Hg, 33.3%). In the overall analysis of IOP measured over the course of 24 hours, mean IOP was significantly lower with bimatoprost or latanoprost than with timolol gel (P<.001; analysis of repeated measures). The analysis of repeated measures also showed a significant difference between bimatoprost and latanoprost (P=.003). In the area-under-the-curve analysis, bimatoprost and latanoprost were superior to timolol gel (P< or =.018) but comparable to each other (P> or =.223). All treatment regimens were well tolerated, with few discontinuations due to adverse events. There were no significant effects on systemic safety parameters.. Once-daily bimatoprost or latanoprost provided significantly better 24-hour IOP control than timolol gel in patients with glaucoma or ocular hypertension. Some measurements suggested a trend for greater efficacy of bimatoprost over latanoprost. All three treatments were well tolerated.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Gels; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Treatment Outcome

The object of this study was to compare the long term efficacy and safety of bimatoprost with timolol in patients with glaucoma or ocular hypertension. In a 12-month extension of two identically designed 1-year, multicenter, randomized, double-masked clinical trials, patients were treated topically with bimatoprost 0.03% QD (n=167), bimatoprost 0.03% BID (n=131), or timolol 0.5% BID (n=81). Main outcome measures were IOP at 8 am and 10 am and safety parameters. Bimatoprost QD provided significantly greater mean reduction from baseline IOP than did timolol at both measurements at each study visit (P< or =.001). At 10 am (peak timolol effect) at month 24, the mean reduction from baseline IOP was 7.8 mm Hg with bimatoprost QD and 4.6 mm Hg with timolol (P<.001). Patients treated with bimatoprost QD also sustained significantly lower mean IOP than timolol-treated patients at every follow-up visit throughout the 2-year study period (P< or =.006). At 10 am at month 24, a significantly greater proportion of bimatoprost QD than timolol patients achieved target pressures of < or =13-18 mm Hg (P< or =.010). Bimatoprost sustained an excellent safety profile during the second year of treatment. Most adverse events were mild, and there were no reports of increased iris pigmentation, uveitis, or CME. The incidence of hyperemia was significantly higher with bimatoprost QD (13.8%) than with timolol (2.5%) (P=.006). Mean reduction from baseline IOP with bimatoprost BID was not significantly different from that with timolol at month 24 at 10 am (P=.474). We conclude that bimatoprost QD provides superior IOP lowering to timolol, and is safe and well tolerated over 24 months of treatment.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol

To study the effect of bimatoprost 0.03% (Lumigan) on ocular hemodynamics in patients with open-angle glaucoma or ocular hypertension.. One randomly selected eye of each of 26 patients with open-angle glaucoma or ocular hypertension was enrolled. Each patient received a drop of bimatoprost 0.03% once daily for 1 month. The effect of bimatoprost on ocular circulation was assessed by color Doppler imaging (CDI), which measured peak systolic, end-diastolic blood flow velocities and resistance indices in the ophthalmic, posterior ciliary and central retinal arteries. Retrobulbar hemodynamics by CDI, intraocular pressure by Goldmann applanation tonometer, blood pressure by cuff, and heart rate by palpation were measured at baseline and at 1 month after bimatoprost treatment.. Blood flow velocities and resistance indices in all retrobulbar vessels showed no statistically significant differences between baseline and bimatoprost condition (P>0.05). Bimatoprost lowered intraocular pressure significantly (P<0.001), with a mean change of 6.5 mmHg (27%) after 1 month of treatment. The systolic (P=0.38) and diastolic (P=0.74) blood pressures and pulse rate (P=0.94) did not show statistically significant differences during the study period.. The results of this study suggest that topical bimatoprost 0.03% significantly reduces intraocular pressure in patients with open-angle glaucoma or ocular hypertension. However, it does not have any effect on retrobulbar hemodynamics in open-angle glaucoma and ocular hypertension.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Blood Flow Velocity; Blood Pressure; Cloprostenol; Eye; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Regional Blood Flow; Tonometry, Ocular; Ultrasonography, Doppler, Color

New effective hypotensive agents have been recently introduced into clinical practice, but often more than one drug has to be used to prevent further visual field loss. The aim of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.03% compared with the association of timolol 0.5% and latanoprost 0.005% in open-angle glaucoma patients.. In this 6-month, prospective, parallel, randomised, investigator-masked clinical trial, 61 glaucomatous patients treated with timolol 0.5% twice in both eyes were enrolled. The timolol 0.5% was replaced by bimatoprost 0.03% once daily (group I) or by latanoprost 0.005% plus timolol 0.5% (group II). IOP measurements were performed at the baseline visit and at days 15, 30, 60, 90, 120 and 180. Digital colour photography was used to evaluate topical side effects.. Fifty-six of the 61 patients were included for the intent-to-treat analysis (28 in group I and 28 in group II). Baseline mean IOP was similar in the two groups (p=0.5). Both treatments lowered the mean IOP at every visit significantly compared with the baseline (p<0.01). Comparing the IOP reductions obtained by the two treatments, no significant differences were found at any time during the study. Conjunctival hyperaemia, skin pigmentation and eyelash growth in group I and headache in group II were the most common side effects observed during the study.. Bimatoprost and the association of latanoprost plus timolol were equally effective in lowering the IOP in glaucomatous patients previously treated with timolol. Latanoprost plus timolol showed a better ocular safety profile.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Safety; Single-Blind Method; Timolol; Treatment Outcome

The topical medication represents the first line therapy for the primary open angle glaucoma. The study is aimed at assessing the structural and immunohistochemical changes of conjunctiva induced by topical glaucoma medication.. For this purpose, we carried out a 40 weeks, prospective, experimental, epidemiological-operational and randomized study enrolling 18 patients (36 eyes) with recently primary open angle glaucoma. The eyes were divided into treatment (non-selective beta blockers or selective, prostaglandin analogues, topical carbonic anhydrase inhibitors) in four groups. The assessment was performed by comparison with control group (4 patients) who was instilled with natural tears (with different preservative). Both the cytology and the conjunctival biopsy specimens were investigated by histological exams and immunohistochemistry using different monoclonal antibodies. The study was performed by collaboration with The National Institute of Research and Development in Pathology and Biomedical Sciences-"V. Babes"-Bucharest.. The morphometric analysis of histological sections of conjunctiva showed the following changes: squamous metaplasia (significant increases in the thickness and number of epithelial cell layers), inflammation (increase the number of lymphocytes, macrophages and fibroblasts) and subconjunctival fibrosis. According to the type of medication, we observed the significant increase of subepithelial collagen density and degenerative changes of fibrocytes, the reduction of extracellular matrix and also the up-regulation of antibodies against matrix metalloproteinase and allergic changes. According to structural changes, the immunohistochemistry confirmed the tendency of chronic inflammation.. This study revealed important structural and immunohistochemical changes of conjunctiva after topical glaucoma medication. The category and the intensity of these changes are dependent on the sort of therapy and the topical treatment period. The findings showed that benzalkonium chloride (the most common preservative of antiglaucoma drugs) is a major factor for conjunctival metaplasia.

Topics: Administration, Topical; Adrenergic beta-Antagonists; Antihypertensive Agents; Benzalkonium Compounds; Betaxolol; Carbonic Anhydrase Inhibitors; Cloprostenol; Conjunctiva; Drug Therapy, Combination; Glaucoma, Open-Angle; Humans; Immunohistochemistry; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Sulfonamides; Thiophenes; Timolol; Travoprost

To compare the efficacy and safety of the concomitant administration of travoprost 0.004% once daily and brinzolamide 0.1% twice daily with those of a fixed combination of latanoprost 0.005%/timolol 0.5% once daily.. Forty-four patients with primary open-angle glaucoma or ocular hypertension with elevated IOP insufficiently responsive to monotherapy were randomly assigned to one of the two treatment groups: concomitant administration of travoprost 0.004% once daily and brinzolamide 0.1% twice daily (TB group: 22 patients) or latanoprost 0.005% plus timolol 0.5% once daily (LT group: 22 patients). Visits were undertaken at screening (current ocular hypotensive therapy was discontinued), baseline (randomization), and after 2 weeks, 1 month, 2 months and 3 months of therapy.. IOP was determined at 9 a.m., 12 p.m. and 4 p.m. at each study visit, and diurnal IOP was calculated as the mean of these recordings. Adverse events were recorded at each visit.. IOP at the baseline visit was similar in both groups. Overall mean IOP was significantly lower in the TB as compared to the LT group after 1 month, 2 month and 3 month follow-up; only 9 a.m. measurements were significantly different, reaching a maximum difference (16.9 +/- 0.9 mmHg vs 18.4 +/- 1.8 mmHg, p < 0.001) at the 3 month check. The percentage of responders (IOP decrease > or = 30%) was higher in the TB group. Both treatments were well tolerated and there were no cases of withdrawal from treatment.. Travoprost 0.004% and brinzolamide 0.1% concomitant therapy showed a greater efficacy than the fixed latanoprost 0.005%/timolol 0.5% combination in terms of absolute IOP decreases. Travoprost/brinzolamide therapy also offered the advantages of a greater percentage of responders.

Topics: Cloprostenol; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sulfonamides; Thiazines; Timolol; Travoprost

Histological changes of, in particular, collagen and extracellular matrix after administration of topical prostaglandin F(2alpha)(PGF (2alpha)) analogues have been reported. In view of this observation, we investigated the influence of PGF(2alpha) analogues on the central corneal thickness.. In a non-randomized, controlled, cross-sectional study, 403 eyes from 208 consecutive patients were examined: 149 eyes (normals/controls) and 79 with ocular hypertension (OHT), 119 eyes with primary open angle glaucoma (POAG) and 56 eyes with normal tension glaucoma (NTG). One experienced ophthalmologist measured the central corneal thickness (CCT) using ultrasound pachymetry (Tomey AL-2000, sequence of 5 measurements with an SD < 3 microm). The central corneal power was measured with the Zeiss keratometer. Depending on the topical treatment, the patients were classified into 4 groups: A) PGF(2alpha) analogues (n = 78), B) carbonic anhydrase inhibitors (n = 26), C) combination of PGF (2)(alpha) analogues and carbonic anhydrase inhibitors (n = 41), D) none of these drugs (n = 258). T tests and multiple linear regression analyses were used for statistical analysis.. CCT was decreased significantly (p < 0.01 each) in eyes treated with PGF(2alpha) analogues (group A: 529 +/- 34 microM), in comparison with the untreated and non-glaucomatous eyes (part of group D: 542 +/- 35 microM, n = 148), untreated glaucomatous/OHT eyes (part of group D: 563 +/- 37 microM, n = 110), eyes treated with carbonic anhydrase inhibitors (group B: 561 +/- 32 microm) and eyes with a topical application of both PGF (2)(alpha) analogues and carbonic anhydrase inhibitors (group C: 555 +/- 48 microM. No correlation was found between CCT and diagnosis (OHT, POAG, NTG, control), gender, central corneal power, and intraocular pressure in a multivariate analysis.. The present findings suggest that the topical application of prostaglandin F(2alpha) analogues onto the cornea reduces the central corneal thickness significantly. These changes might be attributed to effects of PGF(2alpha) analogues on the extracellular matrix of the corneal stroma via upregulation of matrix metalloproteinases. In clinical practice, corneal thinning under local PGF (2)(alpha) analogue treatment could result in underestimation of intraocular pressure levels as measured by applanation tonometry.

Topics: Acetazolamide; Administration, Topical; Adult; Aged; Carbonic Anhydrase Inhibitors; Cloprostenol; Collagen; Cornea; Corneal Topography; Cross-Sectional Studies; Dinoprost; Drug Therapy, Combination; Extracellular Matrix; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Travoprost; Ultrasonography

A drug utilization trial was performed to investigate acute versus short-term effects after switching or adding bimatoprost in open-angle glaucoma patients over a 3- month observation period.. One (1) eye was randomly chosen from 47 glaucomatous patients (abnormal visual field and/or abnormal optic nerve and intraocular pressure (IOP) above 21 mmHg without treatment). Only patients who did not reach the target IOP with their ongoing treatment were recruited in this study. IOP was measured at baseline, after 1 hour, and 2 hours from the first instillation and after 1 week, 1, and 3 months of treatment.. The IOP before bimatoprost administration was 20.16+/-3.6 mmHg (mean+/-standard deviation). There was no statistically significant decrease of IOP after 1 hour (mean IOP, 19.96+/-4.25 mmHg) and after 2 hours (mean IOP, 17.73+/-3.24 mmHg). Statistically significant (p<0.001) decreases after 1 week (mean IOP, 16.48+/-2.9 mmHg), after 1 month (mean IOP, 16.48+/-2.9 mmHg) and after 3 months (mean IOP, 16.15+/-2.7 mmHg) were found.. The results suggested that bimatroprost had a significant acute effect on IOP in monotherapy, while no significant effect was found when the therapy was switched or added. The effect for primary open-angle glaucoma was very evident. There was no specific side effect attributable to combining bimatoprost with any of the treatments in use.

Topics: Administration, Topical; Aged; Ambulatory Care Facilities; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Ophthalmic Solutions

The aim of this study was to evaluate differences in the persistency and treatment costs for latanoprost, bimatoprost, or beta-blockers in open-angle glaucoma or ocular hypertensive patients.. This study was a retrospective, multicenter, parallel, active-controlled comparison of patients who were prescribed with ocular hypotensive monotherapy between September 1996 and August 2002.. 1,182 patients were included. The Kaplan Meier life table analysis showed that latanoprost was continued longest among the groups for the first year of therapy (p=0.02). A significant difference existed between groups in the final intraocular pressure for latanoprost (17.3+/-3.9, N=357), for bimatoprost (18.0+/-3.6, N=146), and for the beta-blockers (17.9+/-3.7, N=335) (p=<0.0001). The average number of visits was statistically higher for beta-blockers (3.3), compared to latanoprost (2.9) and bimatoprost (3.1) (p=0.01). Further, the mean number of medicine changes was greater for bimatoprost (0.45) and beta-blockers (0.47) than for latanoprost (0.27) (p=0.0008). The cost of visits and medications was lowest for beta-blockers ($119.3+/-$78.9) and highest for bimatoprost ($163.8+/-$51.2) (p<0.0001).. Patients were more persistent with latanoprost and demonstrated lower intraocular pressure, fewer visits, and fewer medicine changes when compared to bimatoprost or beta-blocker therapy. In contrast, the beta-blocker group provided lower overall cost.

Topics: Adrenergic beta-Antagonists; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Costs; Economics, Pharmaceutical; Female; Glaucoma, Open-Angle; Health Care Costs; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Office Visits; Patient Compliance; Prostaglandins F, Synthetic; Retrospective Studies; Safety

Primary open-angle glaucoma (POAG) is a chronic and progressive optic nerve and retinal nerve fiber layer neuropathy, with characteristic visual field damage. The intraocular pressure (IOP) is typically higher than the level considered statistically normal. Although there is no known cure, appropriate reduction of IOP with hypotensive drugs (eg, the topical prostaglandin analogue travoprost) delays the progression of POAG. Chemical-stability studies of travoprost performed by the manufacturer suggest that the stability of travoprost is maintained beyond the expiration date, which is 6 weeks after the laminated packaging has been opened.. The goal of this study was to assess the efficacy and tolerability of travoprost 0.004% ophthalmic solution, 6 to 12 weeks after its expiration date, in patients with POAG.. This randomized, controlled, investigator-blinded study was conducted at 2 centers in Brazil: the Ophthalmology Department, Federal University of Goiás, Goiânia, and the Ophthalmology Department, Santa Casa de Misericordia Hospital in São José do Rio Preto, Sao Paulo. Patients with POAG (in 1 or both eyes) were randomly assigned to receive travoprost, either from a bottle from which the laminated packaging had been removed and that had been stored at room light and temperature for 6 weeks (ie, after the expiration date; opened group), or from a bottle that had been sealed until first use by the patient (control group). Drug was to be administered, 1 drop in the lower conjunctival sac (in the affected eye[s]), QD between 7 pm and 9 pm, for 6 weeks. IOP was measured at study weeks 0 (baseline), 4, and 6. The 2 treatment groups were compared with regard to hypotensor effect and incidence of adverse events (AEs).. : Thirty-one patients completed the study (55 eyes; 28 right and 27 left eyes; 35 eyes of women, 20 eyes of men). The mean (SD) ages of the opened and control groups were 61.8 (13.5) and 62.8 (14.1) years, respectively. Twenty-four patients were included in both treatment groups (ie, 1 eye per group). The baseline IOP was similar between the 2 treatment groups. There was a significant reduction in IOP in both groups at 4 and 6 weeks (both, P < 0.001 vs baseline). However, no significant differences in IOP were found between the 2 treatment groups at any time during the study. Conjunctive hyperemia and a burning sensation in the eye immediately after application were the only AEs reported; the incidence of these was similar between the 2 treatment groups.. In this study of patients with POAG, IOPs and AEs were similar in eyes receiving 6 weeks of treatment with travoprost 0.004% ophthalmic solution, either from bottles from which the laminated packaging had been opened and that had been stored at room light and temperature for 6 weeks (ie, after the expiration date), or from bottles that had been sealed until first use by the patient. These results suggest that travoprost remains effective for at least 12 weeks after the laminated packaging has been opened.

Topics: Cloprostenol; Conjunctivitis; Drug Stability; Drug Storage; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Product Packaging; Travoprost

To compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with latanoprost 0.005%.. Multicenter, randomized, investigator-masked clinical trial.. After washout of glaucoma medications, ocular hypertension or glaucoma patients were randomly assigned to once-daily bimatoprost 0.03% (n = 133) or latanoprost 0.005% (n = 136) for 6 months. The primary outcome measure was mean change from baseline IOP (8 AM, 12 PM, 4 PM). Secondary measures included mean IOP, ophthalmologic examination, adverse events, and the percentage of patients reaching specific target IOPs.. Mean change from baseline IOP was significantly greater for bimatoprost patients than for latanoprost patients at all measurements on each study visit; 1.5 mm Hg greater at 8 AM (P <.001), 2.2 mm Hg greater at 12 PM (P <.001), and 1.2 mm Hg greater at 4 PM (P =.004) at month 6. At the end of the study, the percentage of patients achieving a > or = 20% IOP decrease was 69% to 82% with bimatoprost and 50% to 62% with latanoprost (P < or = .003). In addition, the distribution of patients achieving target pressures in each range (< or = 13 to < or = 15 mm Hg, >15 to < or = 18 mm Hg, and > 18 mm Hg) showed that bimatoprost produced lower target pressures compared with latanoprost at all times measured (P < or = .026). Few patients were discontinued for adverse events (6 on bimatoprost; 5 on latanoprost). On ophthalmologic examination, conjunctival hyperemia (P <.001) and eyelash growth (P =.064) were more common in bimatoprost patients.. Bimatoprost is more effective than latanoprost in lowering IOP. Both drugs were well tolerated, with few discontinuations for adverse events.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Safety

To test the efficacy of bimatoprost 0.03% 2D for lowering intraocular pressure (IOP) in patients affected by primary open-angle glaucoma or ocular hypertension who did not respond to treatment with latanoprost 0.005% 2D.. Prospective, randomized clinical trial with a cross over design (two 30-day treatment phases with a 30-day washout phase in between).. Fifteen patients were enrolled. Random allocation to treatment to a single eye only of every subject.. (1) IOP > 22 mmHg in both eyes on current treatment (on three separate readings > 24 hours apart), (2) angle wide open in both eyes, (3) no pseudoexfoliation and/or pigment dispersion in either eye, (4) documented medical history consistent with < 10% IOP decrease in both eyes on 2-month treatment with latanoprost 0.005% every day.. The following variables were measured at each study visit: (1) IOP (Goldmann applanation tonometry, 5 readings, 8 AM, 12 noon, 4 PM, 8 PM, and 12 midnight); (2) visual acuity (Early Treatment of Diabetic Retinopathy Study chart, logarithm of the minimum angle of resolution); (3) estimate of conjunctival hyperemia based on 5 standard photographs (graded as "none," "trace," "mild," "moderate," and "severe").. IOP.. IOP data (mean and standard deviation) were the following: baseline = 24.7 +/- 0.9 mmHg, after washout = 24.8 +/- 1.1 mmHg, after latanoprost phase = 24.1 +/- 0.9 mmHg, after bimatoprost phase = 18.1 +/- 1.7 mmHg. IOP on bimatoprost proved lower than both baseline (P < 0.0001) and latanoprost (P = 0.0001). Thirteen of 15 patients showed a > or =20% IOP decrease with bimatoprost treatment. None of the 15 patients showed a > or =20% decrease of IOP after 30 days of latanoprost treatment. No significant IOP changes were observed in the fellow untreated eye in each patient throughout the study. Trace-to-mild conjunctival hyperemia was recorded more often with bimatoprost phase (P = 0.035).. Thirteen of 15 patients, who were nonresponders to latanoprost, 0.005%, 2D, were successfully treated with bimatoprost, 0.03%, 2D. Bimatoprost treatment was associated with a higher incidence of trace-to-mild conjunctival hyperemia than latanoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular

To Internet Advance publication at ajo.com Feb 13, 2003. compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost, bimatoprost, and travoprost in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).. Interventional study.. This 12-week, randomized, parallel-group study was conducted at 45 US sites. Previously treated patients with OAG or OH and an IOP > or =23 mm Hg in one or both eyes after washout received either latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily in the evening. At baseline and after 6 and 12 weeks of therapy, masked evaluators measured IOP in triplicate at 8:00 AM, 12 noon, 4:00 PM, and 8:00 PM, and masked investigators graded conjunctival hyperemia before the 8:00 AM IOP measurement. The primary efficacy outcome measure was change between baseline and Week 12 in the 8:00 AM IOP (time of peak drug effect).. In all, 410 of 411 randomized patients were included in intent-to-treat analyses (latanoprost, 136; bimatoprost, 136; travoprost, 138). Baseline mean 8:00 AM IOP levels were similar (P =.772); by week 12, reductions were observed in all 3 groups (P <.001 for each). Adjusted (ANCOVA) reductions in mean IOP at 8:00 AM were similar (P =.128) as were those at 12 noon, 4:00 PM, and 8:00 PM. Fewer latanoprost-treated patients reported ocular adverse events (P <.001, latanoprost vs bimatoprost), fewer reported hyperemia (P =.001, latanoprost vs bimatoprost), and average hyperemia scores were lower at week 12 (P =.001, latanoprost vs bimatoprost).. Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in OAG and OH patients. Latanoprost exhibited greater ocular tolerability.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Safety; Travoprost; Treatment Outcome

The aim of the present prospective masked study was to assess the effect of bimatoprost monotherapy on ocular blood flow and intraocular pressure (IOP) in eyes of primary chronic angle closure glaucoma patients already on concomitant timolol and pilocarpine. Thirty two patients of bilateral primary chronic angle closure glaucoma (PCACG) on topical timolol 0.5% twice a day and pilocarpine 2% three times daily were switched over to bimatoprost 0.03% once daily in both eyes. Intraocular pressure (IOP) and pulsatile ocular blood flow (POBF) were recorded before and after starting bimatoprost and were followed up every four weeks for three months. Bimatoprost had statistically significant (p < 0.05) mean IOP reduction from 19.3 +/- 6.6 to 13.5 +/- 4.5 mmHg (30.5%) and there was improvement from 858 +/- 260 to 1261 +/- 321 microL/min (46.8%) in mean pulsatile ocular blood flow (p < 0.05). Conjunctival hyperemia (32%) was the most common adverse effect of bimatoprost. Bimatoprost 0.03% monotherapy improved ocular blood flow and provided a better diurnal IOP control than concomitant timolol-pilocarpine in eyes with primary chronic angle closure glaucoma and was found to be well tolerated.

Topics: Administration, Topical; Adrenergic beta-Antagonists; Aged; Amides; Bimatoprost; Chronic Disease; Cloprostenol; Drug Therapy, Combination; Eye; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Pilocarpine; Prospective Studies; Pulsatile Flow; Regional Blood Flow; Single-Blind Method; Timolol; Treatment Outcome

To evaluate the clinical effectiveness of bimatoprost (Lumigan, Allergan, Inc.) when used as a replacement for latanoprost (Xalatan, Pharmacia) in the treatment of glaucoma and ocular hypertension.. This was a community-based, two-month, open-label, multicenter, trial. Patients with glaucoma or ocular hypertension who needed additional IOP lowering or who were intolerant of other glaucoma medications were placed on bimatoprost therapy (alone or in combination with other drugs at the physician's discretion).. This first report of the data from this study focuses on those patients for whom the physician chose to replace latanoprost therapy with bimatoprost therapy (n = 1283). After 2 months of bimatoprost therapy, the mean decrease in IOP was 3.4 mm Hg and many more patients had achieved low target pressures. The percentage of patients achieving a target pressure of < or =18 mm Hg doubled from 33% to 66% (P <.001). The percentage of patients achieving target pressures of < or =15 mm Hg and < or =14 mm Hg was approximately 3 to 4 times greater at the end of the study than the beginning; increasing from 11% to 36% and from 6% to 26%, respectively (P <.001). A subgroup analysis showed comparable improvements in IOP-control regardless of the previous treatment regimen or whether bimatoprost was used alone or in combination with other medications. The most commonly reported adverse event was conjunctival hyperemia (3.7%; 47/1283).. Bimatoprost therapy is well-tolerated and helps many more patients reach low target pressures when used as a replacement for latanoprost in a variety of treatment regimens.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Resistance; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Time Factors; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic

We compared differences associated with use of travoprost and latanoprost on both progression of perimetric loss over time and associated costs among black patients.. Patients with primary open-angle glaucome or ocular hypertension were randomly assigned to one of four arms in a 12-month, double-masked study: travoprost (0.004% or 0.0015%), latanoprost (0.005%), or timolol (0.5%). Forty-nine patients received 0.004% travoprost, 43 received latanoprost, and 40 received timolol. We applied algorithms found in published studies that link intraocular pressure (IOP) control to visual field progression and calculated the likelihood of visual field deterioration based on IOP data. This was used to estimate differences in medical care costs.. The average IOP was lower for patients receiving travoprost than for patients receiving latanoprost or timolol (17.3 versus 18.7 versus 20.5 mm Hg respectively, P < .05). Travoprost-treated patients had a smaller predicted change in visual field defect score (VFDS) than latanoprost-treated patients and timolol-treated patients, and significantly fewer were expected to demonstrate visual field progression. Medical care costs would be higher for latanoprost-treated and timolol-treated patients.. Recent studies have provided algorithms linking IOP control to changes in visual fields. We found that treatment with travoprost was associated with less visual field progression and potential cost savings.

Topics: Aged; Antihypertensive Agents; Black People; Cloprostenol; Disease Progression; Double-Blind Method; Drug Costs; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol; Travoprost; United States; Vision Disorders; Visual Fields

To compare the safety and intraocular pressure (IOP)-lowering efficacy of once-daily travoprost (0.0015% and 0.004%) to twice-daily timolol 0.5%.. Prospective, 6-month, randomized, controlled, multicenter, double-masked, phase III study.. Six hundred five patients with open-angle glaucoma or ocular hypertension.. Patients with an 8 AM IOP between 24 to 36 mmHg in at least one eye (the same eye) at two eligibility visits received either travoprost 0.0015%, travoprost 0.004% (dosed every day), or timolol 0.5% (dosed twice daily).. Mean IOP at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher baseline IOP.. The mean IOP was significantly lower for both concentrations of travoprost compared with timolol. Travoprost was statistically superior to timolol at 9 of 13 visits, with differences in IOP reductions ranging from 0.9 to 1.8 mmHg (0.0015%) and 10 of 13 visits with differences in IOP reductions from 0.9 to 2.4 mmHg (0.004%). Mean IOP changes from baseline ranged from -6.0 to -7.5 mmHg (0.0015%), -6.5 to -8.0 mmHg (0.004%), and -5.2 to -7.0 mmHg for timolol. Hyperemia was experienced at rates of 29.2% (59 of 202) for travoprost 0.0015%, 42.8% (86 of 201) for travoprost 0.004%, and 8.9% (18 of 202) for timolol. Iris pigmentation changes were observed in 1.0% (2 of 200) of patients receiving travoprost 0.004% with no changes noted in the travoprost 0.0015% group or the timolol group. A decrease in pulse and systolic blood pressure was observed in the timolol group. There were no other clinically relevant or statistically significant changes from baseline in ocular signs or laboratory values, and no serious, related, unexpected adverse events were reported for any group.. Travoprost (0.0015% and 0.004%), dosed once daily in the evening, is statistically superior or equal to timolol 0.5% dosed twice daily at all treatment visits during this 6-month study. IOP reductions of up to 2.0 mmHg greater than timolol were found in the travoprost 0.004% pooled data group. Travoprost is safe and well tolerated in patients with open-angle glaucoma or ocular hypertension.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Cloprostenol; Double-Blind Method; Drug Evaluation; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Safety; Timolol; Travoprost; Treatment Outcome

To compare the safety and efficacy of bimatoprost and latanoprost in patients with primary open-angle glaucoma or ocular hypertension.. This was a 30-day, multicenter, double-masked, randomized, clinical trial. Patients (n = 64) diagnosed with primary open-angle glaucoma or ocular hypertension were randomly assigned to receive bimatoprost 0.03%, latanoprost 0.005%, or vehicle topically in both eyes once daily, in the evening, for 29 days. The primary endpoint was the reduction in IOP from baseline on day 14 and day 29. Secondary outcome measures included eye examinations and safety parameters.. Bimatoprost and latanoprost significantly lowered IOP from baseline (p <.001). Bimatoprost lowered IOP more than latanoprost at every timepoint measured (bimatoprost: 25-34% reduction, 5.9-8.9 mm Hg; latanoprost: 20-31% reduction, 4.4-7.9 mm Hg), although the between-group differences did not reach statistical significance. Over the 12-hour course of IOP measurements on day 29, bimatoprost provided better diurnal IOP control than latanoprost (p =.0378, area under the curve of diurnal IOP reductions, 1-way ANOVA with pairwise t-test). Both treatment regimens were safe and well tolerated, with no significant between-group differences in reports of specific adverse events. The most common side effect was conjunctival hyperemia, which was similarly apparent in the bimatoprost and latanoprost treatment groups.. At the end of this 30-day trial, once-daily bimatoprost 0.03% provided better diurnal IOP control than latanoprost and was safe and well tolerated in patients with ocular hypertension and glaucoma.

Topics: Administration, Topical; Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Double-Blind Method; Female; Glaucoma, Open-Angle; Hemodynamics; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Lipids; Male; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Safety; Tonometry, Ocular

This study evaluated the safety and intraocular pressure-lowering efficacy of two concentrations of travoprost (0.0015% and 0.004%) compared with latanoprost 0.005% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.. Eight hundred one patients with open-angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.0015%, travoprost 0.004%, latanoprost 0.005%, or timolol 0.5%. The efficacy and safety of travoprost (0.0015% and 0.004%) daily was compared with latanoprost daily and timolol twice daily for a period of 12 months.. Travoprost was equal or superior to latanoprost and superior to timolol with mean intraocular pressure over visits and time of day ranging from 17.9 to 19.1 mm Hg (travoprost 0.0015%), 17.7 to 19.1 mm Hg (travoprost 0.004%), 18.5 to 19.2 mm Hg (latanoprost), and 19.4 to 20.3 mm Hg (timolol). For all visits pooled, the mean intraocular pressure at 4 PM for travoprost was 0.7 mm Hg (0.0015%, P =.0502) and 0.8 mm Hg (0.004%, P =.0191) lower than for latanoprost. Travoprost 0.004% was more effective than latanoprost and timolol in reducing intraocular pressure in black patients by up to 2.4 mm Hg (versus latanoprost) and 4.6 mm Hg (versus timolol). Based on a criterion of 30% or greater intraocular pressure reduction from diurnal baseline or intraocular pressure 17 mm Hg or less, travoprost 0.0015% and 0.004% had an overall response to treatment of 49.3% and 54.7%, respectively, compared with 49.6% for latanoprost and 39.0% for timolol. Iris pigmentation change was observed in 10 of 201 of patients (5.0%) receiving travoprost 0.0015%, six of 196 of patients (3.1%) receiving travoprost 0.004%, 10 of 194 of patients (5.2%) receiving latanoprost, and none of the patients receiving timolol (0 of 196). The average ocular hyperemia score was less than 1 on a scale of 0 to 3, indicating that on average patients experienced between none/trace and mild for all treatment groups. There were no serious, unexpected, related adverse events reported for any therapy.. Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist, is equal or superior to latanoprost and superior to timolol in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In addition, travoprost 0.004% is significantly better than either latanoprost or timolol in lowering intraocular pressure in black patients. Travoprost is safe and generally well tolerated in the studied patient population.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Eye Color; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Iris; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Pigmentation Disorders; Prodrugs; Prostaglandins F, Synthetic; Safety; Timolol; Travoprost; Treatment Outcome

This 9-month study compared the intraocular pressure (IOP)-lowering efficacy and safety of once-daily travoprost ophthalmic solutions (0.0015% and 0.004%) with twice-daily timolol 0.5%.. This study was conducted using a double-masked, randomized, parallel-group design; adult patients with open-angle glaucoma or ocular hypertension (IOP between 24 and 36 mm Hg, inclusive at 9 am and between 21 and 36 mm Hg, inclusive, at 11 am and 4 pm on two eligibility visits after an appropriate washout of previous treatments). In both eyes, the travoprost vehicle (placebo) was instilled at 9 am and travoprost (0.0015% or 0.004%) was instilled at 9 pm, or timolol 0.5% was instilled at both times. The primary efficacy variable was mean IOP measured at 9 am, 11 am, and 4 pm at baseline and follow-up visits.. Five hundred seventy-three patients were randomized to the study treatments. Mean IOP, which was combined across study visits, was lower with travoprost 0.004% than with timolol 0.5% at 9 am (P = 0.0246), 11 am (P = 0.0039), and 4 pm (P = 0.0004). Intraocular pressure was lower with travoprost 0.004% than with travoprost 0.0015% at 11 am (P = 0.0314), the time of peak drug activity. Mean IOP was consistently lower with travoprost 0.0015% than with timolol 0.5%. Mean IOP reductions from baseline were significantly (P less than equal 0.0001) greater with travoprost 0.004% (8.0-8.9 mm Hg) than with timolol 0.5% (6.3-7.9 mm Hg). The most frequent related adverse events were hyperemia, pruritus, discomfort, pain, and iris pigmentation changes. The local tolerance was better in the timolol group compared with patients receiving travoprost. There were no serious unexpected treatment-related adverse events in any group.. Travoprost 0.004% reduced diurnal mean intraocular pressure significantly more than timolol 0.5%. Both concentrations of travoprost were well tolerated and safe for use in patients with open-angle glaucoma or ocular hypertension.

Topics: Administration, Topical; Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Travoprost; Treatment Outcome

To evaluate the intraocular pressure-lowering efficacy and safety of travoprost 0.0015% and 0.004%, dosed daily in the evening compared with vehicle, in patients with open-angle glaucoma or ocular hypertension, whose intraocular pressure was not adequately controlled on timolol 0.5% twice daily (twice daily).. Subjects who qualified at screening began a run-in period dosing timolol twice daily for 3 weeks. If the subjects had an intraocular pressure of 24 to 36 mm Hg at 8 AM and 21 to 36 mm Hg at 10 AM and 4 pm in at least one eye on timolol, they were randomized to one of two concentrations of travoprost (0.0015% or 0.004%) or vehicle solution every day and were followed for 6 months. Four hundred twenty-six subjects were randomized. The mean intraocular pressure at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher intraocular pressure was used for the analysis.. Mean baseline values (25 mm Hg) for subjects at eligibility (while maintained on timolol) were not significantly different (P <.0001) among the treatment groups. The intraocular pressure was lowered an additional -5.7 to -7.2 mm Hg and -5.1 to -6.7 mm Hg in the travoprost 0.004% and 0.0015% concentrations, respectively. These changes were significantly (P < or =.0001) different from the vehicle group (-1.3 to -2.8 mm Hg). The intraocular pressure range on treatment at all visit times over the 6-month treatment period ranged from 17.9 to 19.2 mm Hg for travoprost 0.004% and 18.3 to 20.1 mm Hg for travoprost 0.0015% compared with 22.4 to 24.1 mm Hg for vehicle. Average hyperemia scores ranged from trace to mild (mean 0.5 on a scale of 0 = none/trace; 1= mild; 2 = moderate; 3 = severe) for all treatment groups. No iris pigmentation changes were observed in any patient during this study. There were no clinically or statistically significant changes from baseline in visual acuity, ocular cells and flare, fundus parameter, cup-to-disk ratio and visual field between the treatment groups. There were no serious adverse events reported for any treatment group.. Travoprost produced clinically relevant and statistically significant additional intraocular pressure reductions from baseline when used adjunctively with timolol in subjects with open-angle glaucoma or ocular hypertension.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Antihypertensive Agents; Chemotherapy, Adjuvant; Cloprostenol; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Safety; Timolol; Travoprost

To evaluate the effects of latanoprost, bimatoprost, and travoprost eye drops and their preservatives on each corneal layer thickness in patients with primary open-angle glaucoma (POAG).. We retrospectively analyzed 79 eyes of 79 patients with POAG who were receiving prostaglandin therapy. Patients were divided into three subgroups according to monotherapy with latanoprost, bimatoprost, and travoprost during a mean of 43.14 ± 19.12 months follow-up period. In addition, the central corneal epithelial thickness (CET), central corneal stromal thickness (CST), and total central corneal thickness (CCT) were measured by anterior segment optical coherence tomography (AS-OCT) at baseline and every six months after treatment initiation at each visit between 9 and 12 o'clock in the morning. Furthermore, intraocular pressure (IOP) was measured with Goldmann applanation tonometry (GAT) after AS-OCT measurements at each visit.. All three groups were not significantly different in age, gender, follow-up period, and mean intraocular pressure values (p > 0.05 for all). The reduction of CCT in the latanoprost, bimatoprost, and travoprost groups was 6.53 ± 3.17, 18.59 ± 8.42, and 10.1 ± 1.13 µm, respectively. The decrease in CST values was 4.65 ± 1.54, 15.84 ± 7.47, 9.69 ± 1.45 µm, and CET values were 1.88 ± 1.66, 2.75 ± 0.73, 0.41 ± 0.54 µm in all groups, respectively. A statistically significant thinning was observed in all corneal layers (p < 0.05) except the CST values in the latanoprost group and CET values in the travoprost group. However, no significant difference was found in the average reduction of CET, CST, and CCT values among the three groups (p > 0.05).. Topical treatment with latanoprost, bimatoprost, and travoprost affects each layer of the cornea separately according to the active and protective substances contained in these eye drops. On the other hand, the thinning effect on the corneal layers was similar in these three drugs because there was no significant difference between the three groups in the total amount of thinning of the corneal layers during the follow-up period.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Retrospective Studies; Tomography, Optical Coherence; Travoprost

To measure the magnitude and duration of the hypotensive effect of two prostaglandin analogues in glaucoma patients using the water drinking test (WDT).. Patients received latanoprost or travoprost every 24 h and then every 48 h. Untreated WDT were performed at 7 am and with treatment 12, 36 and 44 h after the last dose; intraocular pressure (IOP) peak, fluctuation and the difference between peak and isolated IOP measurements at consultation times were calculated.. Forty-one eyes of 21 patients with primary open-angle glaucoma were included; 22 eyes received latanoprost, and 19 received travoprost. Mean untreated isolated IOP was 17.20 standard deviation (S.D.) 3.73 and 16.95 S.D. 2.61 mmHg and peak pressure 22.45 S.D. 2.91 and 21.58 S.D. 3.79 mmHg, for the latanoprost and travoprost groups, respectively. With treatment, peak pressure was reduced by 22.64% and 20.29% at 12 h, 18.44% and 14.64% at 36 h and 16.17% and 14.46% at 44 h, respectively. The fluctuation without treatment was 4.36 and 5.11 mmHg, and with treatment at 12 h was reduced to 2.77 and 2.89 mmHg, increasing again at 36 and 44 h.. A hypotensive effect was evident up to 44 h after the last dose of latanoprost and travoprost, similar for the two drugs and decreasing over time. IOP fluctuation was only reduced at 12 h.

Topics: Antihypertensive Agents; Cloprostenol; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Prostaglandins F, Synthetic; Water

The effects of antihypertensive therapy are often determined by patient compliance with the prescribed treatment plan. Acceptance of conservative-free forms of drugs leads to a decrease in the frequency and severity of side effects, reduces the need for the use of artificial tears, which lowers the cost of treatment for the patients.. to evaluate the hypotensive effectiveness of a fixed combination of bimatoprost (0.03%) and timolol (0.5%), and its effect on the ocular surface in patients with newly diagnosed advanced glaucoma.. The study was conducted during February-November 2018, and included 46 patients (76 eyes) with newly diagnosed POAG and healthy volunteers (control group). All patients underwent visometry, ICare rebound tonometry (Tiolat, Finland), elastometry with Maklakov tonometer (using 5 g, 10 g and 15 g loads), automated perimetry (AP) (Octopus-600, Haag-Streit diagnostics, Switzerland), optical coherence tomography (OCT) of the macular zone and optic nerve head, pachymetry (Spectralis OCT, Heidelberg Engineering, Germany). At the start of the study and one month after the start of treatment with the drug Ganfort (Allergan, USA), patients were examined to evaluate the state of their ocular surface: Norn's test, Schirmer's test, vital staining with lissamine green, and an OSDI questionnaire.. At the start of treatment, administration of a fixed combination of bimatoprost and timolol led to a decrease in intraocular pressure by 7.9 (37.7%) mm Hg (V=271,. The use of a fixed combination of bimatoprost and timolol, while effectively reducing IOP, did not result in statistically significant changes in the ocular surface. Some improvement of both objective and subjective indicators of the state of ocular surface associated with the use of the Ganfort drug was noted in patients of the observation group.. Эффективность гипотензивной терапии часто определяется соблюдением пациентами назначенной терапии. Применение бесконсервантных форм препаратов снижает частоту и выраженность побочных эффектов, уменьшает необходимость использования слезозаместительных препаратов, что положительно влияет на стоимость лечения.. Оценить гипотензивную эффективность фиксированной комбинации биматопроста (0,03%) с тимололом (0,5%) и ее влияние на глазную поверхность у пациентов с впервые выявленной глаукомой в развитой стадии.. Работа выполнена в период с февраля по ноябрь 2018 г. Исследовались 46 пациентов (76 глаз) с впервые выявленной первичной открытоугольной глаукомой (ПОУГ) и здоровые люди (группа контроля). Всем пациентам проведена визометрия, точечная контактная тонометрия ICare (Tiolat, Финляндия), эластотонометрия тонометрами Маклакова (грузом 5, 10 и 15 г), компьютерная периметрия (КП) с использованием прибора Octopus 600 (Haag-streit diagnostics, Швейцария), оптическая когерентная томография (ОКТ) макулярной зоны и диска зрительного нерва, пахиметрия с помощью Spectralis OCT (Heidelberg Engineering, Германия). На старте исследования и через 1 мес после начала лечения препаратом «Ганфорт» (Аллерган, США) оценивали состояние глазной поверхности: тест Норна, проба Ширмера, витальное окрашивание лиссаминовым зеленым и анкетирование по опроснику OSDI.. На старте лечения прием фиксированной комбинации биматопроста и тимолола привел к снижению офтальмотонуса на 7,9 мм рт.ст. (37,7%) (V=271,. Применение фиксированной комбинации биматопроста и тимолола при хорошей гипотензивной эффективности не повлекло за собой статистически значимых изменений глазной поверхности. Следует отметить некоторое улучшение объективных и субъективных показателей, непосредственно связанных с применением препарата «Ганфорт» в группе наблюдения.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Timolol; Treatment Outcome

Selective laser trabeculoplasty (SLT) is an effective treatment to treat open-angle glaucoma with a low risk of complications. The case is presented of a 73 year-old woman with uncontrolled primary open-angle glaucoma who underwent selective laser trabeculoplasty in both eyes and developed bilateral choroidal effusion.

Topics: Aged; Amides; Brimonidine Tartrate; Choroid Diseases; Cloprostenol; Combined Modality Therapy; Drug Combinations; Emergencies; Exudates and Transudates; Female; Glaucoma, Open-Angle; Humans; Laser Therapy; Timolol; Trabeculectomy

To present a case of topical prostaglandin analogue-induced skin pigmentation in a location previously never reported, with a differential diagnostic significance.. An 83-year-old man successfully treated for primary open-angle glaucoma of both eyes with the bimatoprost/timolol fixed combination for 6 years reported increased pigmentation of the skin of the nasal septum and alae. According to his report, the darkened skin area was not present when he was a young or middle-aged man. The patient had noted periocular pigmentation and deepening of the upper lid sulcus on both sides, which developed during the years of his bimatoprost/timolol treatment. Dermatology consultation excluded any nevus, malignancy, or other pathology as a cause of the pigmentation. The otorhinolaryngology consultation failed to identify any pathologic condition in the nasal cavity, but described mild chronic senile rhinitis.. The acquired pigmentation of the skin of the nasal septum and alae in our patient represents a new form of cutaneous pigmentation induced by topical prostaglandin analogue therapy, which may have differential diagnostic significance in clinical practice. We speculate that the senile rhinitis of the patient increased the exposure of the nasal skin to the prostaglandin analogue solution drained via the nasolacrimal duct, and could therefore play a role in the development of skin pigmentation in this location.

Topics: Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Eyelid Diseases; Glaucoma, Open-Angle; Humans; Male; Nasal Septum; Nose Diseases; Skin Pigmentation; Timolol

Topics: Aged, 80 and over; Amides; Bimatoprost; Cloprostenol; Eyelashes; Female; Glaucoma, Open-Angle; Humans; Hypertrichosis; Iris Diseases; Pigmentation Disorders

To determine the 24-hour effects of travoprost with sofZia on intraocular pressure (IOP) and ocular perfusion pressure as well as the endurance of IOP lowering after last dosing.. Prospective, open-label study.. Forty subjects with open-angle glaucoma or ocular hypertension were admitted to our sleep laboratory for three 24-hour sessions monitoring IOP, blood pressure (BP), and heart rate. The first baseline session occurred after medication washout or immediately after enrollment for treatment-naïve patients. A second 24-hour monitoring session was performed after 4 weeks of once-nightly treatment of travoprost with sofZia. The medication was then discontinued and a third 24-hour session was completed 60-84 hours after the last dose taken. IOP measurements were taken using a pneumotonometer every 2 hours in the sitting position during the 16-hour diurnal period and in the supine position during the 8-hour nocturnal period. Ocular perfusion pressure was defined as 2/3[diastolic BP + 1/3(systolic BP - diastolic BP)] - IOP.. Treatment with travoprost with sofZia significantly lowered mean diurnal and nocturnal IOP levels from baseline (diurnal 18.1 ± 3.9 to 15.3 ± 3.3 mm Hg; nocturnal 20.6 ± 3.6 to 19.4 ± 3.4 mm Hg, P < .01 for both). Once treatment was discontinued, mean IOP remained at levels significantly less than baseline during both the diurnal (16.6 ± 3.8 mm Hg) and nocturnal periods (19.4 ± 3.5 mm Hg). Mean baseline ocular perfusion pressure was significantly increased during the diurnal but not the nocturnal period (diurnal 73.7 ± 11.4 to 76.5 ± 10.3 mm Hg, P = .01; nocturnal 64.4 ± 12.6 to 64.2 ± 11.1 mm Hg, P = .67).. Travoprost with sofZia significantly lowers IOP throughout the diurnal and nocturnal periods, and increases ocular perfusion pressure in the diurnal, but not the nocturnal, period in open-angle glaucoma and ocular hypertension. The treatment effect on IOP endures for at least 84 hours after the last dose.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Circadian Rhythm; Cloprostenol; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Tonometry, Ocular; Travoprost

To evaluate 24-hour continuous intraocular pressure (IOP) monitoring with a telemetric contact lens sensor (CLS) to detect prostaglandin-induced IOP reduction.. In this prospective interventional study 9 ocular hypertensive and primary open-angle glaucoma patients were washed out from IOP-lowering medication for 6 weeks. One study eye per patient underwent 3 baseline 24-hour measurement curves 4 days apart: 2 curves with Sensimed Triggerfish CLS and 1 curve with Goldmann applanation tonometry (GAT). Then the patients received travoprost monotherapy for 3 months. The 24-hour CLS and GAT curves were repeated on the study eyes under treatment at the end of the third month.. The 24-hour GAT IOP (mean±SD) decreased from 22.91±5.11 to 18.24±2.49 mm Hg (P<0.001). In contrast, the means of the 3 CLS curves showed no significant difference (152.94, 142.35, and 132.98 au, P=0.273). No difference was seen when the SD values of the 3 CLS curves were compared (133.51, 132.18, and 110.98 au, P=0.497). All CLS curves showed an increasing time trend (P≤0.001). Correlation of all 3 CLS curves of the individual eyes was high (r=0.726), but no correlation was seen between the corresponding CLS curve periods and GAT IOP values either at baseline (r=-0.223, P=0.546) or under treatment (r=0.320, P=0.402). No difference was seen between the erect/sitting (waking) and supine (sleeping) period CLS values (P>0.05).. Our results suggest that the current CLS technique cannot be clinically used to monitor IOP decrease induced by topical medication in glaucoma, and has limited value in identification of transient IOP elevation periods.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Monitoring, Ambulatory; Ocular Hypertension; Prospective Studies; Telemetry; Tonometry, Ocular; Travoprost

To report the clinical outcomes in Chinese patients with primary open-angle glaucoma and ocular hypertension treated with bimatoprost 0.03% therapy.. Two hundred sixty-three Chinese patients with primary open-angle glaucoma and ocular hypertension who needed initial or additional intraocular pressure (IOP) lowering were recruited in this prospective, open-label, multicenter clinical study and were treated with bimatoprost 0.03%. Patients received bimatoprost 0.03% as initial, replacement or adjunctive IOP-lowering therapy, and follow-up visits were performed at week 1, and month 1 and 3 of the bimatoprost treatment. The efficacy outcome measure was the post-treatment IOP level. The safety outcome measures included the rate of medication-related symptoms, physical signs, reported adverse events, and the level of conjunctival hyperemia.. Among 240 patients who could be categorized by pre-existing therapies and the bimatoprost therapy regimen in the study, IOP values observed in all medication conditions showed significant IOP reduction at all study visits compared with baseline. At 3 months, 8.0 ± 3.7 mmHg (32.0%) reduction in IOP was observed in treatment-naive patients after bimatoprost monotherapy; in the patients previously on various therapy regimens, 1.9 ± 2.8 mmHg (9.5%) to 6.4 ± 6.1 mmHg (24.8%) additional IOP lowering was achieved after switching to bimatoprost monotherapy or bimatoprost combination therapy. The most common adverse event was conjunctival hyperemia, mainly of trace and mild intensity.. Our results show that bimatoprost 0.03% was effective in lowering IOP with favorable safety in Chinese primary open-angle glaucoma and ocular hypertension patients.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; China; Cloprostenol; Conjunctival Diseases; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies

The recently developed confocal cornea microscopy offers the opportunity to examine pathologies of the cornea and to gain insight into the activity of innate immunity. We aimed to investigate the corneal epithelial and Langerhans cell (LC) densities along with dry eye parameters in primary open-angle glaucoma (POAG) subjects, treated with either of two commercially available travoprost 0.004 % topical medications containing different preservatives. (1: benzalkonium chloride 0.015 % (TravBAK) and 2: polyquaternium-1 (PQ) 0.001 % (TravPQ). Consecutive case series of nineteen POAG patients on TravBAK (mean age: 64.8 ± 13.6 years), nineteen POAG patients on TravPQ (mean age: 66.8 ± 11.3 years) and nineteen age-matched healthy control subjects (63.8 ± 8.2 years). Ocular surface disease index (OSDI), lid parallel conjunctival folds (LIPCOF), Schirmer test (ST) and tear break up time (TBUT) were assessed, and then corneal epithelial and LC densities were investigated with confocal microscopy. Tear production was significantly reduced in both glaucoma patient groups compared to healthy individuals (p < 0.05). TBUT was significantly reduced and epithelial cell densities were significantly greater in patients treated with TravBAK compared to healthy individuals (p < 0.05 for all). LC densities were greater in both glaucoma groups compared to control subjects (p < 0.05 for all). Travoprost therapy may compromise ocular surface. The limited alertness of the corneal immune system found in patients with TravPQ can be considered as indicators of a less disturbed ocular surface and better controlled corneal homeostasis.

Topics: Aged; Antihypertensive Agents; Case-Control Studies; Cloprostenol; Cornea; Epithelial Cells; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Langerhans Cells; Male; Microscopy, Confocal; Middle Aged; Preservatives, Pharmaceutical; Tears; Travoprost

Intraocular pressure (IOP)-lowering effects of 0.03 % bimatoprost in eyes with open angle glaucoma (OAG) was compared with that of 0.005 % latanoprost.. Thirty-one patients with OAG who had received three kinds of ocular hypotensive agents (latanoprost, beta-blocker, and topical carbonic anhydrase inhibitor) were included in this study. In these patients, bimatoprost was administered for 8 weeks after switching from latanoprost. The IOP was measured with a goldmann applanation tonometer (GAT) at the baseline, and Weeks 2, 4 and 8 after switching the treatment. The IOP at the baseline and at the end of treatment period was measured at 10:00, 12:00, and 16:00. The central corneal thickness (CCT) was measured at each visit using an ultrasonic pachymeter.. At the baseline, the mean IOP was 18.8 ± 1.4 mmHg, and the CCT was 530.7 ± 29.5 μm. At Week 8 after switching treatment, bimatoprost significantly reduced the IOP by 2.0 ± 1.6 mmHg from the baseline (p < 0.001). The CCT tended to be reduced (p = 0.009; Repeated ANOVA) and Bonferroni test indicated a statistically significant decrease of the CCT at Week 8 in comparison with that at the baseline (p = 0.013).. Bimatoprost has an IOP-lowering effect superior to that of latanoprost in glaucoma patients after switching from latanoprost. The use of bimatoprost can decrease the CCT for a relatively short period in a linear regression fashion.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Corneal Pachymetry; Drug Substitution; Female; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular

To evaluate the intraocular pressure (IOP) lowering effect of 2 trabecular microbypass stents and postoperative travoprost in patients with open-angle glaucoma (OAG) not controlled on 2 medications preoperatively.. S.V. Malayan Ophthalmology Centre, Yerevan, Armenia.. Prospective open-label nonrandomized study.. This prospective pilot study involved 39 qualified phakic patients with OAG, medicated IOP between 18 mm Hg and 30 mm Hg, and unmedicated baseline (after washout) IOP between 22 mm Hg and 38 mm Hg. Patients received 2 stents (iStent) through a clear corneal incision and were prescribed travoprost starting the night of postoperative day 1. Intraocular pressure, complications, and various safety measures were assessed at examinations through 18 months and planned for every 6 months thereafter until month 60. A washout of medications was performed 13 months postoperatively.. All patients achieved an IOP reduction of 20% or more from baseline to 12 months with reduction of 1 medication and with IOP 18 mm Hg or less. Follow-up through 18 months showed that medicated IOP decreased from 22.2 mm Hg ± 2.0 (SD) on 2 medications preoperatively to 14 mm Hg or less on 1 medication at the postoperative visits. The mean unmedicated IOP decreased from 25.3 ± 1.8 mm Hg preoperatively to 17.1 ± 2.2 mm Hg 13 months postoperatively. No intraoperative or serious device-related adverse events occurred.. Patients with OAG treated with 2 trabecular microbypass stents and 1 presumptive postoperative medication achieved a significant and sustained reduction in IOP and medication through 18 months.. Dr. Katz served as the medical monitor for this study. All authors are consultants to Glaukos Corp.

Topics: Antihypertensive Agents; Aqueous Humor; Cloprostenol; Combined Modality Therapy; Corneal Pachymetry; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Microsurgery; Middle Aged; Pilot Projects; Prospective Studies; Stents; Tonometry, Ocular; Trabecular Meshwork; Travoprost; Visual Acuity; Visual Fields

This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting.. In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≤21 mm Hg.. Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP ≤21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP ≤21 mm Hg group, respectively.. In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.. NCT01594970.

Topics: Administration, Topical; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Republic of Korea; Tonometry, Ocular

To investigate the incidence of deepening of the upper eyelid sulcus (DUES) with topical use of travoprost in Japanese glaucoma patients.. This prospective study enrolled 32 primary open-angle glaucoma Japanese patients who had been treated topically with travoprost unilaterally for 6 months at baseline, and started treatment in both eyes. The patients were observed during outpatient visits at 2, 4, and 6 months. At every visit, the photographs of both eyes and forehead were displayed randomly and the presence of DUES was diagnosed when 3 examiners unanimously rated the case as positive. The patients were also asked if they noticed any subjective symptom of DUES. Sex, refraction, and intraocular pressure (IOP) were evaluated as potential risk factors.. DUES was identified objectively in 34% (11/32) of the patients after 2 months of treatment, and in 53% (17/32) after 4 and 6 months of treatment. The incidence was significantly higher in older patients (P<0.05), but not related to sex, refraction, pretreatment and posttreatment IOP, and IOP reduction. Finally, 41% (7/17) of patients with objectively diagnosed DUES noticed the presence of DUES by themselves. No patient dropped out of the study because of DUES.. DUES is a common side effect of topical travoprost treatment in Japanese glaucoma patients.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Asian People; Cloprostenol; Eyelid Diseases; Eyelids; Female; Glaucoma, Open-Angle; Humans; Incidence; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Travoprost

Although useful for reducing intraocular pressure (IOP), bimatoprost (BIM) can cause deepening of the upper eyelid sulcus (DUES), one of the symptoms of prostaglandin-associated periorbitopathy (PAP). We investigated recovery from BIM-induced DUES after switching treatment to latanoprost (LAT).. Prospective, observer-masked, open-label study.. Twenty-five Japanese patients suffering from primary open-angle glaucoma treated with LAT in both eyes for longer than 6 months and requiring further IOP reduction were prospectively enrolled in the study. During the first 6 months after the switch to BIM, 15 of the 25 patients (60 %) developed DUES. Among these patients, 13 were switched back to LAT and re-examined for DUES at 2-month intervals for an additional 6 months.. Two months after the switch back to LAT, for 11 of the 13 patients (85 %) the DUES symptoms had either decreased or disappeared, and this was maintained for at least 6 months. During this time, 6 of 8 patients (75 %) subjectively positive for DUES self-reported a decrease in DUES.. Although DUES is a frequent side effect of treatment with BIM, switching to LAT may reverse the condition for most patients.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Substitution; Eyelid Diseases; Eyelids; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Recovery of Function

To assess the efficacy and tolerability of benzalkonium chloride (BAK)-free travoprost after transition from BAK-preserved latanoprost.. This was a prospective, open-label, multicenter study in patients with open-angle glaucoma or ocular hypertension who had been treated with latanoprost monotherapy for at least 3 months. The main outcome measures were superficial punctate keratopathy (SPK), hyperemia, and intraocular pressure (IOP). At baseline, 1, 3, and 12 months, hyperemia, SPK, and IOP were consecutively assessed. Hyperemia was assessed using a 4-grade scale. SPK was assessed by fluorescence staining observed by Area-Density classification. The IOP was measured by Goldmann applanation tonometry.. One hundred and fourteen patients participated in this study. Twenty-eight patients discontinued medications by 1 month. Sixty-seven patients completed the study. Transition from latanoprost to BAK-free travoprost showed no significant effect on hyperemia at 1 month, but showed significant decreases at 3 and 12 months compared with baseline (P<0.05). The prevalence of SPK, especially its severity score, at all points were significantly reduced compared with baseline (P<0.05). The IOP at baseline and at 12 months after transition was 14.9±3.4 and 14.3±3.3 mm Hg, indicating a significant reduction after the change in regimen compared with baseline (P<0.05).. Treatment for 12 months with BAK-free travoprost after BAK-preserved latanoprost resulted in fewer ocular surface complications, as indicated by the reduced prevalence of SPK and decreased hyperemia, and no clinically relevant changes in IOP. BAK-free travoprost may have beneficial effects on the ocular surface while showing IOP-lowering efficacy comparable with BAK-preserved eye drops.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Conjunctival Diseases; Cornea; Corneal Diseases; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome

The objective was to assess the long-term economic consequences of the medical management of glaucoma in the UK.. The economic evaluation was conducted using the results from a 10-year Markov model based around 3 key triggers for a switch in medical therapy for glaucoma, namely: lack of tolerance (using hyperemia as a proxy); intraocular pressure (IOP) not meeting treatment benchmark; and glaucoma progression. Clinical data from a comprehensive systematic literature review and meta-analysis were used. Direct costs associated with glaucoma treatment are considered (at 2008/9 prices) from the perspective of the UK NHS as payer (outpatient/secondary care setting). Using this model, the economic consequences of 3 prostaglandin-based treatment sequences were compared.. Drug acquisition costs account for around 8% to 13% of the total cost of glaucoma and, if ophthalmologist visits are included, amount to approximately £0.80 to £0.90 per day of medical therapy. The total long-term costs of all prostaglandin strategies are similar because of a shift in resources: increased drug costs are offset by fewer clinic visits to instigate treatment switches, and by avoiding surgery or costs associated with managing low vision. Under the latanoprost-based strategy, patients would have longer intervals between the need to switch therapies, which is largely due to a reduction in hyperemia, seen as a proxy for tolerance. This leads to a delay in glaucoma progression of 12 to 13 months. For every 1000 clinic appointments, 719 patients can be managed for 1 year with a latanoprost-based strategy compared with 586 or 568 with a bimatoprost or travoprost-based strategy.. Drug acquisition costs are not a key driver of the total cost of glaucoma management and the cost of medical therapy is offset by avoiding the cost of managing low vision. Economic models of glaucoma should include the long-term consequences of treatment as these will affect cost-effectiveness. This analysis supports the hypothesis that the economic and clinical benefits can be optimized by minimizing therapy switches.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Drug Substitution; Female; Follow-Up Studies; Glaucoma, Open-Angle; Health Care Costs; Health Resources; Humans; Intraocular Pressure; Latanoprost; Male; Markov Chains; Models, Economic; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost; United Kingdom

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Neoplasms; Female; Glaucoma, Open-Angle; Humans; Melanoma; Nevus, Pigmented

While topical ocular hypotensive agents cause secretion of endogenous prostaglandin (PG), systemic and topical non-steroidal anti-inflammatory agents inhibit its production; thus, they may interfere with therapeutic efficacy. This study aimed to investigate the effect of add-on treatment with ketorolac on intra-ocular pressure (IOP)-lowering effects of three different PG analogues.. This study included 30 adult bilateral glaucoma patients who had been receiving PG analogues for primary open-angle glaucoma (n = 25) or pseudoexfoliation glaucoma (n = 5). Ketorolac tromethamine 0.5% and placebo drops were administered to the right and left eyes of the patients, respectively, 4 times a day for 1 week. IOP measurements were performed at baseline, within the first 4 h after application, on days 1, 3 and 7, and 1 and 7 days after discontinuation of the treatment.. Eyes receiving ketorolac had significantly lower IOP throughout the treatment period (p < 0.001). Patients who were on latanoprost, travoprost and bimatoprost did not differ with regard to the change in IOP (p = 0.780). After discontinuation, pressures became similar on day 1 (p = 0.796) and day 7 (p = 0.314).. In glaucoma patients, ketorolac significantly enhances the IOP-lowering effects of latanoprost, travoprost and bimatoprost.

Topics: Adult; Aged; Aged, 80 and over; Amides; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ketorolac Tromethamine; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins A, Synthetic; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

To report two cases of choroidal detachment induced by topical bimatoprost.. Two males, aged 95 (case 1) and 74 years (case 2), were referred to our department for massive choroidal detachment. Case 1 was a one-eyed patient, and the affected eye of case 2 had undergone trabeculectomy 2 years previously. Both affected eyes were pseudophakic and treated for 6 months with topical bimatoprost/timolol fixed combination for open angle glaucoma (case 1) and pseudoexfoliation glaucoma (case 2). In both cases, symptoms appeared immediately after starting the drops and progressively worsened thereafter. In both affected eyes, moderate conjunctival hyperemia was noted, anterior segment examination and intraocular pressure were normal, and fundus examination revealed a massive choroidal detachment. This diagnosis was confirmed by B-scan ultrasonography. An adverse effect of bimatoprost was suspected, and the drug was discontinued, leading to the complete resolution of the choroidal detachment within 3 weeks in both eyes.. Choroidal detachment is a rare adverse effect which is not specific to bimatoprost but which has been also reported with the other prostaglandin analog drops. Its exact cause remains unclear, but is probably linked to the combination of enhanced uveoscleral outflow and pro-inflammatory properties. In all cases, the discontinuation of the prostaglandin analog led to the complete resolution of the choroidal detachment within 3 weeks.

Topics: Administration, Ophthalmic; Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Choroid Diseases; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male

To determine the most cost-effective treatment option for patients with newly diagnosed mild open-angle glaucoma: observation only, treatment with generic topical prostaglandin analogs (PGAs), or treatment with laser trabeculoplasty (LTP).. Using a Markov model with a 25-year horizon, we compared the incremental cost-effectiveness of treating newly diagnosed mild open-angle glaucoma with PGAs, LTP, or observation only.. The incremental cost-effectiveness of LTP over no treatment is $16,824 per quality-adjusted life year. By comparison, the incremental cost-effectiveness of PGAs over no treatment is $14,179 per quality-adjusted life year, and they provide greater health-related quality of life relative to LTP. If PGAs are 25% less effective owing to poor patient adherence, LTP can confer greater value.. Prostaglandin analogs and LTP are both cost-effective options for the management of newly diagnosed mild open-angle glaucoma. Assuming optimal medication adherence, PGAs confer greater value compared with LTP. However, when assuming more realistic levels of medication adherence (making them 25% less effective than the documented effectiveness reported in clinical trials), at current prices for PGAs, LTP may be a more cost-effective alternative.

Topics: Antihypertensive Agents; Cloprostenol; Cost-Benefit Analysis; Glaucoma, Open-Angle; Health Status; Humans; Laser Therapy; Markov Chains; Medication Adherence; Middle Aged; Quality of Life; Quality-Adjusted Life Years; Trabeculectomy; Travoprost

To investigate the day-to-day repeatability of intraocular pressure (IOP) measurements.. A prospective cohort study of untreated patients presenting with primary open-angle glaucoma or ocular hypertension presenting with IOP>21 mm Hg. IOP was measured by masked Goldmann tonometry at 08:00, 11:00 and 16:00 at each of the three weekly visits. After starting travaprost (0.004%) to both eyes, the measurements were repeated for a further three weekly visits. Day-to-day repeatability was estimated before and after commencing medication and reported as the coefficient of repeatability and coefficient of variability.. At the 8:00 time point, mean IOPs were 26.1 and 17.9 mm Hg in the eye with higher pressure before and after starting treatment, respectively. Coefficient of repeatability and coefficient of variability were 6.8 mm Hg and 10.0%, respectively, before treatment, and 4.6 mm Hg and 10.5% on treatment. Therefore, before treatment and after starting medication the IOP lay within a range of ±20% of the mean IOP with 95% confidence.. The non-therapeutic variability from day to day significantly undermines the precision of IOP estimation and of the estimation of medication effectiveness even when the time of day is standardised in patients with primary open-angle glaucoma/ocular hypertension.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Cohort Studies; Female; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Reproducibility of Results; Tonometry, Ocular; Travoprost; Visual Fields

To prospectively assess the efficacy of switching to a travoprost/timolol fixed-combination (TTFC) therapy from latanoprost monotherapy.. This was a prospective, open-label study in which patients with either primary open-angle glaucoma or ocular hypertension who had been undergoing latanoprost monotherapy for at least 3 months were enrolled. Baseline was defined as the time when the subjects were started on latanoprost monotherapy. Examination periods were defined as 1, 2, and 3 months the switch to TTFC therapy, and 1-2 months after the switch back to latanoprost monotherapy. The parameters examined were intraocular pressure (IOP), conjunctival hyperemia, and corneal erosion, as well as blood pressure and heart rate. A survey was conducted 1 and 3 months after the switch to TTFC therapy with a focus on each subject's impressions.. Among the 70 enrolled subjects, the 58 (29 men, 29 women) who completed the protocol were analyzed. The IOP before and at 1, 2, and 3 months after the switch to TTFC therapy was measured and again after the switch back to latanoprost monotherapy. The results indicated that TTFC therapy significantly reduced the IOP (P < 0.001) and significantly decreased the heart rate, but it did not significantly change either the systolic or diastolic blood pressure. TTFC therapy also did not significantly change either the conjunctival hyperemia or corneal erosion. In the questionnaire, the patients indicated that their impression was that there was no significant difference between the two ophthalmic solutions.. Compared to latanoprost monotherapy, TTFC therapy significantly reduced IOP and decreased the heart rate in the patient cohort. No differences were found in terms of patients' impressions.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Cloprostenol; Drug Combinations; Drug Substitution; Female; Glaucoma, Open-Angle; Heart Rate; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Surveys and Questionnaires; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome; Young Adult

Ganfort eye drops are indicated for adult patients with open-angle glaucoma who have poor response to topical β-blockers or prostaglandin analogues. They contain 0.3 mg of bimatoprost (a prostaglandin) and 5 mg of timolol (β-blocker). The authors present a case of a 45-year-old man with glaucoma presenting with shortness of breath. On admission, he had a normal heart rate, pulse oximetry and examination. Despite being of low risk stratification using the Wells score and the Modified Geneva Score for pulmonary emboli, CT pulmonary angiogram scan subsequently showed extensive bilateral multiple large pulmonary emboli. This case demonstrates that the systemic absorption of ocular β blockers is extremely high and it bypasses the first pass metabolism. Therefore, even one drop of Ganfort into each eye once a day was sufficient to disguise the tachycardia of a large pulmonary emboli.

Topics: Amides; Anticoagulants; Cloprostenol; Drug Combinations; Dyspnea; Glaucoma, Open-Angle; Heart Rate; Humans; Male; Middle Aged; Ophthalmic Solutions; Pulmonary Embolism; Radiography; Tachycardia; Timolol

We investigated the appearance frequency of eyelid pigmentation and eyelash bristles after the use of five types of prostaglandin (PG) analogs.. This study included 250 eyes from 250 patients diagnosed with primary open-angle glaucoma or ocular hypertension who were treated with either latanoprost, travoprost, tafluprost, bimatoprost, or isopropyl unoprostone for >3 months in only one eye. Photographs of both eyes were obtained, and the images were assessed by three ophthalmologists who were masked to treatment type. The existence of eyelid pigmentation and eyelash bristles was judged, and images of the left and right eyes were compared. Subjective symptoms regarding the existence of eyelid pigmentation and eyelash bristles were investigated through a questionnaire.. There was no significant difference between the five types of medications with regard to eyelid pigmentation (P=0.537). Use of isopropyl unoprostone resulted in a significantly lower incidence of eyelash bristles (P<0.0001). The questionnaire investigation showed that eyelid pigmentation and eyelash bristles were significantly more frequent with travoprost (42.0% and 42.0%, respectively) and bimatoprost (58.0% and 60.0%, respectively) than with other three medications (P<0.0001).. The appearance frequency of eyelid pigmentation was similar among the five types of PG analogs studied, and eyelash bristles appeared less frequently with isopropyl unoprostone use. Patients are conscious of eyelash bristles; therefore, these adverse effects should be sufficiently explained to patients before PG administration.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Eyelashes; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Skin Pigmentation; Surveys and Questionnaires; Travoprost

To investigate the intraocular pressure (IOP) lowering effect of bimatoprost (BIM) 0.03% and the potential additional effect of the BIM 0.03%/timolol 0.5% fixed combination (BTFC) in eyes with ocular hypertension, primary open-angle glaucoma, or exfoliation glaucoma.. Following an appropriate washout period that varied with previous medication, participants with ocular hypertension, primary open-angle glaucoma, or exfoliation glaucoma were treated with evening-dosed BIM for 5 weeks. They were then given evening-dosed BTFC for another 5 weeks. One randomly selected eye was evaluated. Goldmann applanation tonometry was performed by the same investigator at 8 a.m., 12 noon, 4 p.m., and 8 p.m. at baseline and at the end of each treatment period.. Thirty-three participants completed the study. Three patients discontinued because of local adverse effects during the BIM treatment period. The mean diurnal IOP (mean ± SD) at baseline, on BIM, and on BTFC were 24.8 ± 5.4, 17.3 ± 3.5, and 14.9 ± 3.1 mmHg, respectively (repeated measures analysis of variance, P < 0.001 for all pairwise comparisons). The individual time-point IOP values showed similar significant reductions. The percentage of IOP reduction from baseline was 30.2% for BIM and 39.9% for the BTFC. The mean ± SD diurnal fluctuation at baseline was 6.8 ± 3.2 mmHg, which decreased to 4.0 ± 3.1 and 2.9 ± 1.4 mmHg on BIM and BTFC, respectively (P < 0.05 for both treatments versus baseline).. Both BIM 0.03% and the BTFC were effective in lowering IOP in eyes with ocular hypertension and open-angle glaucoma. However, the fixed combination provided an additional statistically significant reduction in IOP compared with BIM 0.03%.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Drug Combinations; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Single-Blind Method; Timolol; Treatment Outcome

Primary open-angle glaucoma is a progressive optic neuropathy that can cause an irreversible loss of vision. A reduction in intraocular pressure (IOP) is beneficial in slowing or halting its progression. Once-per-day monotherapy glaucoma medications, such as prostaglandin analogues, are effective in lowering IOP while maintaining patients' adherence. Achieving the desired target IOP often requires multiple medications. The present study evaluates punctal occlusion of both the inferior and superior puncta as an adjunctive therapy to travoprost ophthalmic solution 0.004% for patients with primary open-angle glaucoma or ocular hypertension in order to reduce IOP.. Thirteen patients who were using travoprost 0.004% ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension received silicone punctal plugs in the superior and inferior puncta of one eye. After one month, the IOP was remeasured. The percentage change of the IOP from the baseline was analysed by using a paired sample t-test.. The mean baseline IOP was 19.82 ± 1.19 mmHg in the test eyes and 18.32 ± 1.11 mmHg in the control eyes. The mean IOP at the one-month visit was 18.23 ± 1.17 mmHg in the test eyes and 18.45 ± 1.04 mmHg in the control eyes. The test eyes demonstrated a decrease in IOP of 1.59 (± 0.95) mmHg from the baseline, or a 6.82 per cent decrease in the IOP from the baseline. The control eyes had an increase in IOP of 0.14 ± 0.77 mmHg from the baseline, or a 1.91 per cent increase in the IOP. The relative difference in the IOP between the test eyes and the control eyes at the one-month visit was 1.73 mmHg, or 8.74 per cent.. Based on the results of this study, punctal occlusion offers a statistically and clinically significant decrease in IOP when it is used as an adjunctive therapy to travoprost 0.004% for patients who are suffering from open-angle glaucoma or ocular hypertension.

Topics: Adult; Antihypertensive Agents; Cloprostenol; Combined Modality Therapy; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Prostheses and Implants; Prosthesis Implantation; Silicones; Travoprost

To compare intraocular pressure (IOP) reduction profiles of bimatoprost 0.03% administered every other night (QOD-HS) compared with every night (QHS) in patients with primary open angle glaucoma and pseudoexfoliation glaucoma.. A retrospective chart review of 68 eyes of 45 consecutive patients who were switched from QHS to QOD-HS bimatoprost due to intolerable conjunctival hyperemia between May 2005 and May 2008. IOP in the morning (AM) and afternoon (PM) of the next day after administration (day 1) and the day after (day 2) on QOD-HS regimen was compared with IOP in the AM and PM when they were on QHS regimen, 4-6 weeks after switching to QOD-HS.. Mean IOPs on QHS bimatoprost were 15.9±3.4 mm Hg in the AM and 15.5±2.7 mm Hg in the PM, whereas mean IOPs on QOD-HS were 14±2 mm Hg (AM) and 14.2±2.5 mm Hg (PM) on day 1, and 14.7±2.6 mm Hg (AM) and 14.4±2.4 mm Hg (PM) on day 2 after administration. Differences between IOP fluctuation on QHS and QOD-HS days 1 and 2, respectively, were not significant (P=0.87 and 0.94).. Every other night dosing of bimatoprost was effective in controlling IOP in this select group of patients with primary open angle glaucoma and pseudoexfoliation glaucoma who had troublesome side effects on bimatoprost 0.03% QHS regimen, and may be considered as an alternative to every day treatment.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Drug Administration Schedule; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Retrospective Studies

To report clinical results of switching to latanoprost therapy in patients with deepening of the upper eyelid sulcus caused by travoprost and bimatoprost.. Prospective, clinical, observational case reports. Four patients presented with eyelid changes giving the eye a sunken eye appearance; two were being treated with travoprost and two with bimatoprost. Both patients on bimatoprost and one of the patients on travoprost therapy were switched to latanoprost while the eyelid sign was evident. The other patient discontinued the travoprost therapy for 4 months and switched to latanoprost therapy 1 month later, i.e., 5 months after discontinuing travaprost therapy. The physical changes in the eyelids were documented by photography and the intraocular pressure by Goldmann applanation tonometry.. Three patients had a resolution of the sunken eye appearance 2 to 3 months after switching to latanoprost. The one patient who switched to latanoprost after recovery of the sunken eye had no recurrence during a 6 months follow-up period. There were no significant changes in the intraocular pressure in any of the subjects.. A deepening of the upper eyelid sulcus is a complication of prostaglandin F2α analogs. However, this side effect may be less common with latanoprost and eyes with this side effect caused by travoprost or bimatoprost may tolerate latanoprost therapy.

Topics: Adult; Aged; Amides; Bimatoprost; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

Because latanoprost and the original formulation of travoprost that included benzalkonium chloride (BAK) have been shown to be similar with regard to tolerability, we compared initial topical intraocular pressure (IOP)-lowering medication change rates in patients newly treated with latanoprost or travoprost-Z monotherapy.. At 14 clinical practice sites, medical records were abstracted for patients with a diagnosis of open-angle glaucoma or ocular hypertension and who were ≥40 years of age, had a baseline and at least one follow-up visit, and had no prior history of ocular prostaglandin use. Data regarding demographics, ocular/systemic medical histories, clinical variables, therapy initiations and reasons for changes, adverse events, and resource utilization were recorded from randomly chosen eligible charts. Primary outcomes were rates of and reasons for changing from the initial therapy within six months and across the full study period (1000 days).. Data from 900 medical charts (latanoprost, 632; travoprost-Z, 268) were included. For both cohorts, average follow-up was >1 year. Cohorts were similar with regard to age (median ~67 years), gender distribution (>50% female), and diagnosis (~80% with open-angle glaucoma). Within six months, rates of index therapy change for latanoprost versus travoprost-Z were 21.2% (134/632) and 28.7% (77/268), respectively (p = 0.0148); across the full study period, rates were 34.5% (218/632) and 45.2% (121/268), respectively (p = 0.0026). Among those who changed their index therapy, insufficient IOP control was the most commonly reported reason followed by adverse events; hyperemia was the most commonly reported adverse event at index therapy change.. In this "real world" study of changes in therapy in patients prescribed initial monotherapy with latanoprost with BAK or travoprost-Z with SofZia, medication changes were common in both treatment groups but statistically significantly more frequent with travoprost-Z.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cohort Studies; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Retreatment; Retrospective Studies; Travoprost

To investigate the clinical relevance of two different preservative formulations, we compared 1-year incidence rates of additional coding of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) in open-angle glaucoma and ocular hypertension patients newly treated with latanoprost with benzalkonium chloride (BAK) or with travoprost-Z with SofZia®.. This was a retrospective study of three U.S.-based patient-centric medical/pharmacy claims databases (MedStat, PharMetrics, i3-Ingenix). Patients were eligible if they filled a prescription for latanoprost or travoprost-Z between October 2006 and Q2 2008 (prescription date = index date) AND were continuously enrolled 6 months prior through 12 months after the index date AND had any open-angle glaucoma or ocular hypertension diagnosis within 90 days prior to the index date AND did not have an ocular surface disease diagnosis during the 180 days prior to the index date AND if they had not had a prescription for the index agent in the 180 days prior to the index date. Time to incidence of new coding for ocular surface disease in the first year post-index was estimated with a composite endpoint: diagnosis of dry eye or ocular infection by ICD-9-CM or Current Procedural Terminology code OR by prescription for cyclosporine ophthalmic emulsion or ocular antibiotics.. In all, 15,933 patients were treated with latanoprost and 7670 with travoprost-Z. Over 1 year, 4.3% of latanoprost and 4.5% of travoprost-Z patients were identified with dry eye (p = 0.28), and 10.9% and 11.1%, respectively, were identified with an ocular infection (p = 0.79). The 1-year incidence of new coding for ocular surface disease also was similar across treatments (13.9% vs 14.3%, respectively; p = 0.48).. The retrospective analysis of three large prescription databases revealed that open-angle glaucoma and ocular hypertension patients newly treated with latanoprost preserved with BAK or travoprost-Z preserved with SofZia did not differ statistically in rates of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) during the first year post-index. Claims-based analyses are limited by nonrandomization and the inability to account for over-the-counter use or samples.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Current Procedural Terminology; Databases, Factual; Dry Eye Syndromes; Eye Infections; Female; Glaucoma, Open-Angle; Humans; International Classification of Diseases; Kaplan-Meier Estimate; Latanoprost; Male; Medicine; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Pharmacy; Prescriptions; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Travoprost

A core assumption for the 1-eye therapeutic trial of ocular hypotensive medications is the symmetrical reduction of intraocular pressure (IOP) in paired eyes. This assumption was evaluated for 24-hour IOP reduction in patients who underwent monotherapy or adjunctive therapy.. Database study.. Patients 41 to 79 years of age with primary open-angle glaucoma or ocular hypertension.. Twenty-four-hour IOP data from the paired eyes of patients undergoing bilateral monotherapy (n = 66) of latanoprost, travoprost, timolol, or brimonidine or bilateral adjunctive therapy (n = 52) with brinzolamide or timolol added to latanoprost monotherapy were analyzed retrospectively. Measurements of IOP were obtained every 2 hours in a sleep laboratory before and after at least 4-week drug treatments. Strengths of association for single-pair IOP reductions and average IOP reductions in the paired eyes during the office-hour, diurnal, nocturnal, and 24-hour periods and in different body positions were analyzed.. Variance for the difference, percentage distribution of large absolute difference, and coefficient of determination (r(2)) in the paired IOP reductions.. The standard deviations for the differences in single-pair IOP reductions from the means were larger than 2.5 mmHg for all periods and body positions under monotherapy and adjunctive therapy. Absolute differences in single-pair IOP reductions of the cutoff thresholds of 3 and 2 mmHg or more occurred in more than 20% and 36% cases, respectively. Corresponding coefficients of determination were 0.240 to 0.374 with monotherapy and 0.215 to 0.381 with adjunctive therapy. When the average differences in the paired IOP reductions were analyzed for a specific period and posture, the standard deviations for the differences in the paired IOP reductions and the percentage distributions of large absolute differences were reduced, and most coefficients of determination were improved.. There is only a weak association between the right- and left-eye responses to IOP-lowering monotherapy or adjunctive therapy during a 24-hour period when single-pair IOP data are considered. Considering the averages of multiple paired IOP responses can improve the strength of the association.. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Topics: Administration, Topical; Adult; Aged; Antihypertensive Agents; Brimonidine Tartrate; Circadian Rhythm; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Posture; Prostaglandins F, Synthetic; Quinoxalines; Retrospective Studies; Sulfonamides; Thiazines; Timolol; Tonometry, Ocular; Travoprost

The authors aim at investigating the possible clinical effects of topical Prostaglandin Analogs on eyelid position and motility with this single masked protocol in a cross-sectional study.. A group (group A) of 182 patients on treatment for glaucoma with prostaglandin analogs (latanoprost, travoprost, and bimatoprost) and a group of 191 age-matched normal controls (group B) were enrolled in the study. Group A was subdivided into 3 subgroups according to the prostaglandin analogs used by the patients. Group A1: 84 patients on latanoprost, group A2: 56 patients on travoprost, and group A3: 42 patients on bimatoprost. Two positive control groups (group H of 115 patients with lower lid involutional entropion or ectropion secondary to horizontal lid laxity (HLL), and a group P of 137 patients with involutive aponeurotic blepharoptosis) were also enrolled in the study. For the upper eyelid, the following parameters were measured: margin-reflex distance (MRD), upper lid crease position, levator function. For the lower lid, the following parameters were used: HLL and lower lid excursion (LLE). Statistical analysis of the data was done to assess whether there was any statistical significant difference for each of the parameter between group A (and its subgroups) and, respectively, groups B, H, and P. Similarly, it was also compared with group B, with group H, and then with group P. Analysis of variance of the eyelid parameters was also carried out in the 3 subgroups A1, A2, and A3.. There was no statistically significant difference for each studied parameter between group B and, respectively, groups A1, A2, A3 and group A, nor there was any statistically significant variance between parameters in the 3 subgroups A1, A2, and A3. The accuracy of the eyelid parameters was confirmed while obtaining statistically significant differences in LLE (P<0.05) and in HLL (P<0.001) comparing group A (and its subgroups) and group H and also in MRD and upper lid crest (P<0.001) comparing group A (and its subgroups) and group P.. There is no evidence that prostaglandin analogs significantly affect the eyelids' tissues to produce eyelid malposition.

Topics: Aged; Aged, 80 and over; Amides; Analysis of Variance; Antihypertensive Agents; Bimatoprost; Case-Control Studies; Cloprostenol; Cross-Sectional Studies; Eyelids; Female; Glaucoma, Open-Angle; Humans; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Single-Blind Method; Travoprost

To determine the direct costs of therapy over 5 years of a European monotherapy cohort begun on a prostaglandin (PTG) versus timolol in patients with primary open-angle glaucoma or ocular hypertension.. A retrospective, multicenter, active-controlled, observational study. Data were abstracted for European patients treated as initial monotherapy in 1996 or afterward, with 5 years of available records.. This study included 271 patients (166 on a PTG and 105 on timolol at baseline). The average cost/month/patient over 5 years was $45.47±12.61 for PTG and $31.50±15.47 for timolol (P<0.001, based on German prices). After 5 years, although there was no difference in number of glaucoma medicines prescribed between groups (1.0 PTGs and 1.1 timolol, P=0.41), the timolol group demonstrated a higher intraocular pressure (17.7±2.9 vs. 16.5±3.0 mm Hg, P<0.001), more medication changes (P=0.01), greater incidence of glaucomatous progression (P=0.04), and less patients persistent on original monotherapy (P<0.001) than the PTG cohort.. Patients originally on timolol monotherapy have a lower cost of care over 5 years than those started on a PTG. However, timolol patients during follow-up may demonstrate a higher intraocular pressure, more progression, more medication changes, and lower persistency of the original monotherapy.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Disease Progression; Drug Costs; Europe; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Retrospective Studies; Time Factors; Timolol; Travoprost; Treatment Outcome

Topics: Amides; Bimatoprost; Cloprostenol; Cosmetics; Drug Industry; Eyelashes; Glaucoma, Open-Angle; Humans; Hypotrichosis

To develop a cost-offset model from a US payer perspective comparing glaucomatous progression and costs among primary open-angle glaucoma (POAG) patients using bimatoprost, latanoprost, or travoprost.. Cost-offset model.. A Markov cohort model was used to estimate glaucomatous progression for POAG patients over 7 years. The model assumed bimatoprost-treated patients had lower resulting intraocular pressure (IOP) (by 1 mm Hg) for all presenting IOP categories than latanoprost- or travoprost-treated patients. Patients with lower IOP were assumed to have lower probability of progression. Those that progressed were assumed to do so at a rate of -0.6 dB per year. Direct costs associated with mean deviation score categories were applied to each treatment cohort to calculate the expected 7-year costs of treating patients with each prostaglandin analogue (PGA). Literature was used to support assumptions. A budget impact analysis was conducted where all travoprost patients switched to generic latanoprost and where all bimatoprost patients switched to generic latanoprost. The base case market share was 22% bimatoprost, 23% travoprost, and 55% latanoprost.. Model results demonstrate that for a managed care plan with 9500 PGA-treated glaucoma patients, exclusive bimatoprost use would prevent progression in 136 additional individuals compared with exclusive travoprost or latanoprost treatment. Model results demonstrate that greater IOP reduction from bimatoprost is associated with increased cost savings compared with latanoprost or travoprost treatments.. Model results demonstrate that greater IOP reduction from bimatoprost could reduce managed care spending.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cohort Studies; Cost-Benefit Analysis; Disease Progression; Glaucoma, Open-Angle; Health Care Costs; Health Status Indicators; Humans; Intraocular Pressure; Latanoprost; Managed Care Programs; Markov Chains; Models, Economic; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Time Factors; Travoprost; United States

To investigate the incidence of deepening of the upper eyelid sulcus (DUES) after use of bimatoprost in Japanese glaucoma patients.. Twenty-five open-angle glaucoma Japanese patients treated with latanoprost in both eyes for 6 months or longer and needing further intraocular pressure (IOP) reduction were enrolled prospectively. Latanoprost was switched to bimatoprost, and the patients were observed at 1, 3, and 6 months. The patients were queried for the presence of DUES at every visit. Sex, refraction, and IOP were evaluated as related factors. The photographs of the eyes and forehead taken at each of the four visits were randomly displayed and judged for the presence of DUES with unanimous confirmation by three examiners.. One month after the switch to bimatoprost, 44% (11/25) of the patients had DUES, including three with unilateral DUES. At 3 and 6 months, 60% (15/25) of the patients had DUES. The incidence was significantly higher in older patients and nonmyopic eyes (P < 0.01), but not related to sex or IOP reduction. Finally, 53.3% (8/15) of the patients objectively judged to have DUES noticed the presence of DUES by themselves. Only one patient dropped out of the study because of DUES (after 3 months).. DUES is an often-observed side effect of bimatoprost topical treatment in Japanese glaucoma patients.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Substitution; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Incidence; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic

To determine whether sponsorship of prostaglandin analogue (PGA) clinical trials results in investigator bias in outcomes when studying intraocular pressure (IOP).. Retrospective, observational cohort study.. A PubMed search was performed for latanoprost or Xalatan, bimatoprost or Lumigan, and travoprost or Travatan, with limits to humans, clinical trials, and English language. Inclusion criteria included randomized controlled trials, open-angle glaucoma, monotherapy with a PGA, baseline IOP ≥ 21 mm Hg, washout period, and minimum 1-month follow-up. Each article was reviewed by 2 independent reviewers. The results of IOP for each PGA were categorized as being sponsored by the parent company (the company manufacturing the PGA); by the competing company (the company manufacturing competing glaucoma therapy); or by a nonindustry source. The mean IOP and changes in IOP from baseline were compared among the 3 categories of sponsorship.. Only studies involving latanoprost were analyzed because of the low number of studies meeting the inclusion criteria for bimatoprost and travoprost. We found 29 and 13 studies that provided 1- and 3-month data, respectively, for analysis. The mean baseline IOPs in the 3 groups (parent company, competing company, nonindustry) were not significantly different (p = 0.47). The mean IOP at 1 (p = 0.72) and 3 months (p = 0.59) and the change in IOP from baseline (p = 0.83 and 0.90, respectively) were not significantly different in the 3 groups. A random-effects metaregression controlling for the covariates of blinding, naïveté to PGAs, and baseline IOP < 24 mm Hg or ≥ 24 mm Hg did not change the findings.. There was no evidence of investigator bias in determining outcomes for IOP in these clinical trials of latanoprost.

Topics: Amides; Antihypertensive Agents; Bias; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Cohort Studies; Drug Industry; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Prostaglandins F, Synthetic; Research Personnel; Research Support as Topic; Retrospective Studies; Travoprost; Treatment Outcome

To investigate long-term resource consumption and clinical outcome of patients with early primary open-angle glaucoma or ocular hypertension treated with prostaglandins in clinical practice in France.. Thirty-four geographically spread specialized hospitals and private practices enrolled consecutive patients receiving, for the first time, a prostaglandin, alone or in combination. The study was based on routine practice and no consultations, examinations, or treatments were mandated by the protocol. Treating physicians recorded each consultation, including all examinations performed, referrals, admissions, and prescriptions. Descriptive analysis of resource consumption and development of intraocular pressure (IOP) and visual fields was performed, for all patients who completed the 4-year follow-up.. The study enrolled 602 patients and 78% completed 4-year follow-up. Mean age was 65 years and mean time since diagnosis was 4 years. Mean IOP was reduced from a baseline of 21.2 mm Hg to 16.5 mm Hg during the first year and remained stable throughout the study. Mean visual fields at baseline were -4.2 mean deviation and stable during the follow-up. Total mean health care costs per patient were €1947, of which medication represented 50%. Over half of the patients (52%) remained on their initial medication during the 4 years. Drug changes were mostly because of inadequate IOP control and the number of treatment switches was significantly related to costs.. This is the first prospective study of treatment with prostaglandins in clinical practice. The results indicate that many patients with early glaucoma managed primarily with prostaglandins will show very little progression over 4 years. Compared with the mid-90s, costs have not increased despite the higher acquisition cost of prostaglandins, as surgical interventions and medical consultations have decreased.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Female; France; Glaucoma, Open-Angle; Health Care Costs; Health Resources; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Registries; Travoprost

Topics: Amides; Antihypertensive Agents; Antineoplastic Combined Chemotherapy Protocols; Bimatoprost; Breast Neoplasms; Cloprostenol; Cyclophosphamide; Doxorubicin; Eyelashes; Female; Glaucoma, Open-Angle; Humans; Latanoprost; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

An open label, multi-center, 6 months observational study of new fixed combination (travoprost 0.004%/timolol 0.5%), in order to evaluate both efficacy (intraocular pressure lowering) and tolerability (patient and investigator satisfaction) of two dosing regimens--evening (PM) and morning (AM). After screening for enrollment, to 40 patients (79 eyes with primary open angle glaucoma or ocular hypertension), new fixed combination travoprost 0.004%/timolol 0.5% was prescribed once a day in the evening (PM). Patients were enrolled according to each investigator decision on indication for travoprost 0.004%/timolol 0.5% fixed combination once a day, without washout period after previous medication. Intraocular pressure was measured at 9 AM at all time control points: at baseline, after 1 month, after 3 months and after 6 month. After 1 month, screening for nonresponders (criteria: 20% intraocular pressure lowering) and subjects with major side effects was performed. At second control visit, after 3 months PM dosing, intraocular pressure was measured and patients were instructed to continue once a day the same medication, but in the morning (AM) for consequent 3 months. After 1 month, reduction in mean intraocular pressure value was 21.66%. At the visit after 3 month, the mean intraocular pressure was 15.67 +/- 2.17 mm Hg (reduction 21.14%). 3 month after dosing regimen changed to AM (6 month after beginning of travoprost 0.004%/timolol 0.5% combination therapy), reduction in intraocular pressure value was 19.86%. The differences (mean +/- standard deviation) in intraocular pressure values after 1, 3 and 6 month were all highly statistically significant compared to baseline values. The tolerability was evaluated in five steps (Likert scale) ranging from unsatisfactory to excellent by both patient and investigator--taken at 3 and 6 month control visit. 95% of patients and 100% of investigators were satisfied with the possibility of choosing dosing regimen for travoprost 0.004%/timolol 0.5% fixed combination. Travoprost 0.004%/timolol 0.5% fixed combination proved sufficient intraocular pressure control dosed either PM or AM with no statistically significant difference between two dosing regimens. Possibility to choose between two dosing regimens gives each practitioner additional reassurance that glaucoma therapy will be individualised to needs of each patient.

Topics: Cloprostenol; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Prospective Studies; Timolol; Travoprost

Travoprost (Travatan(®)), a prostaglandin ophthalmic solution, is a second-line therapy for open-angle glaucoma, according to the Clinical Practice Guideline of the American Optometric Association. Recently, travoprost has been used as a first-line therapy in many patients because of its effectiveness and a once-daily dosing. It lowers the intraocular pressure by enhancing the aqueous humor outflow. Based on the product information, adverse effects such as ocular hyperemia, eye pain, pruritus, and bradycardia have been associated with travoprost therapy. Significant bradycardia is defined as heart rate or pulse of less than 60 beats per minute. We report on an 87-year-old man who experienced asymptomatic bradycardia while using travoprost ophthalmic solution. The pulse in our patient ranged from 42 to 50 beats per minute while receiving travoprost therapy during his hospitalization. Travoprost ophthalmic solution was discontinued because it was thought to be the likely cause of significant sinus bradycardia in our patient. After travoprost discontinuation, the average pulse of the patient was 66 beats per minute. Based on Naranjo's Scoring System (an objective tool) for assessing the likelihood of drug-induced adverse effects, the score of 3 was obtained, which indicated a "possible" adverse effect. To our knowledge, this is the first case report about significant bradycardia possibly associated with travoprost therapy.

Topics: Administration, Topical; Aged, 80 and over; Bradycardia; Cloprostenol; Glaucoma, Open-Angle; Humans; Male; Ocular Hypertension; Travoprost

To assess the safety and efficacy of changing antiglaucoma therapy to the travoprost 0.004%/timolol 0.5% (TTFC) fixed combination from previous monotherapies.. Prospective, open-label, observational, multicenter cohort. A change was done from prior monotherapy at day 0 to TTFC dosed once a day, regardless in the evening or in the morning, without washout period. Active evaluation of systemic and local tolerability (adverse events), and efficacy. i.e., intraocular pressure (IOP) lowering was done at control 1 (day 30), control 2 (day 90) and control 3 (day 120).. 40/155/170 patients (79/309/339 eyes) completed the study (120 days/ 90 days/baseline, respectfully). At control 1 excluded were patients with low tolerability (severe hyperemia (6 patients), discomfort (4), chest pain (1)) and non responders (IOP lowering less than 15% from baseline IOP or target IOP >18 mmHg (4 patients)). Mean IOP at control 1 was 15.92 +/- 1.85 mm Hg (21.66% reduction) for 155 patients (non responders excluded), at control 2 was for 155 patients 15.67 +/- 2.17 mm Hg (21.14% reduction), and at control 3 for 40 patients 16.28 +/- 1.59 mm Hg (19.86% reduction). At control 2 analysis of IOP reduction by 4 groups of previous monotherapy (timolol 0,5% (N = 33/66), latanoprost 0.005% (N = 49/98), betaxolol 0.5% (N = 30/60), and travoprost 0.004% (N = 43/85) was performed. 40 patients/79 eyes endured to control 3 (after day 90 free samples were not available for all patients). Analysis of IOP reduction by 4 groups of previous monotherapy medications was performed (timolol 0.5% (N = 7/14), latanoprost 0.005% (N = 14/28), betaxolol 0.5% (N = 7/14), travoprost 0.004% (N = 12/23)).. Changing patients from prior monotherapy to TTFC can provide on average a further reduction in IOP, while demonstrating a favorable safety profile.

Topics: Antihypertensive Agents; Cloprostenol; Drug Combinations; Drug Substitution; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Timolol; Travoprost

To assess patient adherence and behaviors with topical once-daily therapy for glaucoma.. Prospective, observational cohort study.. One hundred ninety-six patients with glaucoma who were being treated with a prostaglandin analog in 1 or both eyes at the Scheie or Wilmer Eye Institutes between August 2006 and June 2007.. Detailed medical history was obtained from each patient. All subjects used the Travatan Dosing Aid (DA; Alcon, Fort Worth, TX) to administer travoprost as prescribed. Devices were collected at 3 months and the data of drop usage was downloaded using software provided with the dosing aid. Data were analyzed for the 8-week period starting 2 weeks after the enrollment visit and ending 2 weeks before the 3-month visit.. Assessment of adherence and patterns of drop usage as indicated by the DA.. A total of 282 subjects consented to be in the study and 86 (30%) withdrew before study completion or had device errors, leaving 196 subjects (70%) with evaluable data at 3 months. The overall mean (+/-standard deviation) adherence rate was 0.71 (+/-0.24), ranging from 0.02 to 0.97. One hundred nine of these patients (55.6%) took greater than 75% of the expected doses. Those with adherence of less than 50% of expected doses showed substantially increased dose taking immediately after the office visit and just before the return visit at 3 months (P = 0.03). The mean adherence rate estimates of the physician and patient self-report were 0.77 and 0.95, respectively. The agreement between the physician assessment and DA-recorded adherence rate showed poor correlation for individual cases (intraclass correlation coefficient, 0.09; 95% confidence interval, 0.00-0.19).. Nearly 45% of patients using an electronic monitoring device who knew they were being monitored and were provided free medication used their drops less than 75% of the time. Patients reported far higher medication use than their actual behavior. The ability of the physician to identify which persons are poorly adherent from their self-report or from other subjective clues is poor.. Proprietary or commercial disclosure may be found after the references.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Attitude to Health; Cloprostenol; Cohort Studies; Drug Monitoring; Female; Follow-Up Studies; Glaucoma, Angle-Closure; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Patient Compliance; Prospective Studies; Surveys and Questionnaires; Travoprost

To investigate the effect of topical prostaglandin analogue use on the efficacy of selective laser trabeculoplasty (SLT) intraocular pressure (IOP) lowering in patients with open-angle glaucoma.. This retrospective study included 123 consecutive patients who underwent 180 degrees SLT for the first time. Eyes were grouped into those that received prostaglandin analogues before and after SLT (n=74) and those that did not (n=49). The main outcome measure was IOP lowering after SLT. Success was defined as > or =20% reduction in IOP without further glaucoma intervention.. There was no significant difference in IOP lowering at 6 months post-laser between the prostaglandin and non-prostaglandin groups (3.9+/-4.8 vs 4.6+/-3.6 mm Hg, P=0.43). Long-term SLT success rates were also not significantly different between the treatment groups (Kaplan-Meier survival analysis, P=0.68). IOP lowering at 6 months was similar in eyes that received no glaucoma medications, monotherapy with or without a prostaglandin analogue, or combination therapy with or without prostaglandin analogues (P=0.81). Logistic regression analysis showed that various patient characteristics including age, sex, type of glaucoma, previous glaucoma surgery, and other glaucoma risk factors did not predict a successful SLT outcome. However, higher pre-operative IOP was found to predict SLT success (odds ratio=1.12, 95% CI=1.02-1.24, P=0.02).. The IOP lowering efficacy of SLT is not influenced by the use of topical prostaglandin analogues.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Kaplan-Meier Estimate; Laser Therapy; Latanoprost; Logistic Models; Outcome Assessment, Health Care; Prostaglandins; Prostaglandins F, Synthetic; Retrospective Studies; Risk Factors; Trabecular Meshwork; Trabeculectomy; Travoprost

To evaluate the intraocular pressure (IOP)-lowering effect of travoprost in normal-tension glaucoma (NTG) over a 12-month follow-up.. Forty-five eyes of 45 patients with unilateral NTG were treated with travoprost (0.004%) once a day for 12 months. Mean IOP and the IOP reduction from baseline were assessed at 0.5, 1, 3, 6, 9, and 12 months after the initiation of the treatment. Adverse ocular event frequency and the frequency of discontinuation of treatment due to adverse events were evaluated.. Mean IOP during 12 months of travoprost treatment ranged from 11.17 to 11.82 mmHg, and the mean IOP reduction in relation to baseline IOP from -2.71 to -3.71 mmHg (-18.3% to -25.1%). Mean IOP and IOP changes in the travoprost-treated and control groups were significantly different at every follow-up (P < 0.05 in each case). Both the magnitude (r = 0.6992) and percentage (r = 0.5464) of IOP reductions correlated positively with baseline IOP values. Ocular adverse events were usually mild to moderate and resolved without treatment.. Travoprost was well tolerated and significantly reduced IOP in NTG patients. In addition, initial IOP reductions were maintained throughout follow-up. Travoprost was found to be more effective in patients with greater baseline IOP.

Topics: Antihypertensive Agents; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Tonometry, Ocular; Travoprost

To evaluate treatment patterns and costs among new initiators of topical prostaglandin analogs in a managed-care population.. Annual costs were modeled using multiple inputs. A retrospective cohort design was used to identify treatment patterns for pharmacotherapy. The study population was identified from pharmacy claims for patients who met study inclusion criteria (patients initiating prostaglandin analog monotherapy). Published studies were used to estimate visit-related resource use and costs were obtained from published and standard sources.. In the cohort analysis, a total of 12 202 patients met study criteria: 2275 received bimatoprost, 7347 received latanoprost and 2580 received travoprost (1808 used the original formulation and 772 used the newer preservative formulation). Of patients meeting study criteria, 50% stopped all glaucoma therapy, 6% switched from their initial prostaglandin therapy, and the remaining 44% stayed on their initial prostaglandin for 1 year. Of patients remaining on prostaglandin analog monotherapy for 1 year, 22.7% of bimatoprost patients, 19.8% of latanoprost patients and 17.9% of travoprost patients (19.7% for the original formulation and 13.7% for the new formulation) required adjunctive therapy. Of those requiring adjunctive therapy, the median number of days until starting adjunctive therapy was 53 days for bimatoprost patients, 63 days for latanoprost patients and 83 days for travoprost patients (70.5 days for the original formulation and 109 days for the new formulation). The resources used at each visit were estimated at $424 for an initial visit and $70 for follow-up visits. Estimated first-year costs were $1294, $1199, and $1186 for patients initiating therapy with bimatoprost, latanoprost, and travoprost, respectively. Estimated travoprost costs were higher for the original formulation ($1203) than for the new formulation ($1160). Sensitivity analyses suggested that the cost estimates are robust to changes in costs and use of adjunctive therapies.. The use of a claims database without compliance data or clinical outcomes and the selection of new initiators of topical prostaglandin analogs limits the findings and does not allow projecting outcomes to all glaucoma patients.. Use of adjunctive therapy in glaucoma is an important driver of glaucoma management costs. Based on the results of this study, it is possible that longer duration of monotherapy with prostaglandin analogs may be associated with lower annual costs. Further study should be conducted to validate these findings.

Topics: Administration, Topical; Adult; Aged; Amides; Bimatoprost; Black People; Cloprostenol; Cohort Studies; Cost of Illness; Female; Follow-Up Studies; Glaucoma, Open-Angle; Hispanic or Latino; Humans; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost; United States

The aim of this study was to verify the influence of prostaglandin analogs and prostamide on central corneal thickness (CCT).. A prospective analysis was done of CCT in glautomatous patients submitted to monotherapy with prostaglandin analogs (latanoprost 0.005% or travoprost 0.004%) or prostamide (bimatoprost 0.03%) during an 8-week period. A control group of patients without any ocular medication was also evaluated. CCT measurements were performed with a commercially available ultrasound pachymeter. A total of 73 patients were included in this study. Mean age was 68.5 +/- 9.2 (range, 48-85) years old.. A statistically significant reduction in CCT was observed in all groups, except the control group (n = 21): Bimatoprost 0.03% group (n = 21): 544.41 +/- 35.4 vs. 540.35 +/- 35.9 microm (P = 0.039); travoprost 0.004% group (n = 17): 538.47 +/- 32.0 vs. 532.25 +/- 30.4 microm (P = 0.009); latanoprost 0.005% group (n = 14): 548.57 +/- 32.4 vs. 543.88 +/- 35.6 microm (P = 0.036).. Topical therapy with prostaglandin analogs and bimatoprost is associated with CCT reduction over a period of at least 8 weeks.

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Diagnostic Techniques, Ophthalmological; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost; Ultrasonography

To document patient/physician perceptions of adverse effects and their relationship to medication changes among patients prescribed prostaglandin analogs.. Medical/pharmacy claims (private U.S. health network) identified patients filling initial topical ocular hypotensive prescriptions from 2001 to 2004; 300 open-angle glaucoma patients prescribed a prostaglandin analog and 103 ophthalmologists were selected by algorithm for telephone interviews. Medical charts for 225/300 interviewed and 75 non-interviewed patients were abstracted. Medication patterns were assessed in pharmacy claims data. Frequency of adverse effects noted by physicians and associations with medication change decisions were examined in charted data. Patients' experiences with adverse effects were compiled from surveys.. In patients treated with latanoprost (N = 4,071), bimatoprost (N = 1,199), or travoprost (N = 1,001), continuous refill of medication through 1 year was seen in 11%, 9%, and 5% of patients, respectively (P = 0.0001; retrospective pharmacy claims). Adverse effects were the second most common reasons noted by physicians for switching medications after lack of efficacy (19% vs. 43%, respectively). Adverse effects were noted in 65% of patient charts. Hyperemia was the most common adverse effect occurring with at least one other adverse effect in 48% of patients with the condition.. Ocular adverse effects, particularly hyperemia, negatively affect patient continuation with therapy and switching.

Topics: Administration, Topical; Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Databases, Factual; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Ophthalmic Solutions; Patient Compliance; Pharmaceutical Services; Practice Patterns, Physicians'; Prescription Drugs; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Travoprost

To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% (Ganfort) among German patients.. Multicenter, observational, open-label study of patients with primary open angle glaucoma or ocular hypertension (n = 606). As determined by participating physicians, patients had insufficient IOP control and required a medication change. They were switched to once-daily fixed-combination bimatoprost/timolol with no wash-out period. IOP was recorded at treated baseline, 4-6 weeks and 12 weeks after switching. Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded.. A total of 405 patients switched from monotherapy, 97 switched from other fixed combinations, and 104 switched from non-fixed combinations. Among all patients, 32.5% had used prostaglandin analog (PGA) monotherapy, 8.7% had been using a fixed combination that included a PGA, and 6.9% had been using an adjunctive combination of a PGA and a beta-blocker. Mean treated baseline IOP (+/-SD) for all patients was 20.7 +/- 3.5 mmHg. Overall, changing medication to fixed-combination bimatoprost/timolol lowered IOP to 16.6 +/- 2.7 mmHg (p < 0.001 vs. baseline) after 4-6 weeks and to 16.1 +/- 2.6 mmHg (p < 0.001) after 12 weeks; reductions of 19.8% and 22.2%, respectively. Combined bimatoprost/timolol provided an additional IOP reduction versus baseline in most subgroups based on prior treatment. At week 12, patients who had previously used a beta-blocker achieved an additional 25.8% decrease from baseline and IOP was reduced by 22.6% in former PGA monotherapy patients. At week 12, 84.6% of all eyes reached a target pressure less than or equal to 18 mmHg. Tolerability of bimatoprost/timolol was rated excellent or good by the physicians for 98.7% of patients and by 96.7% of the patients themselves. Few adverse events occurred during the treatment period.. Although this study was limited by its observational design, our results show that the fixed combination of bimatoprost 0.03%/timolol 0.5% was effective, well tolerated, and safe in a broad patient population.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Administration Schedule; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Optic Disk; Timolol; Visual Fields

Subclinical inflammation may be observed in patients using topical antiglaucomatous drugs. The objective of this study was to investigate inflammation in conjunctiva of glaucoma patients using prostaglandin analogs, by the detection of an immunogenetic marker (HLA-DR) and compare the effect of 3 different drugs: latanoprost, bimatoprost, and travoprost in the induction of this inflammation.. Thirty-three patients with primary open-angle glaucoma were evaluated without and with prostaglandin analogs topical therapy. Imprints of conjunctival cells were obtained, fixed on glass slides, and prepared for immunohistochemical analysis.. Before the use of prostaglandin analogs, 4 of the 33 patients evaluated presented expression of HLA-DR in the conjunctiva (mild). After 1 month on prostaglandin analog treatment, all but 1 patient presented HLA-DR staining. HLA-DR expression of these 32 patients was scored as mild (19 patients), medium (11 patients), or intense (2 patients). The differences were statistically significant both when the presence and the increased expression of HLA-DR were considered (P<0.001). When the 3 different groups were analyzed (latanoprost, bimatoprost, and travoprost) no statistically significant difference was found (P=0.27).. The use of prostaglandin analogs eye drops provokes a subclinical inflammatory reaction, observed by HLA-DR expression, even after a short period of treatment, independently of the class of the prostaglandin analogs used.

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Biomarkers; Cloprostenol; Conjunctivitis; Female; Glaucoma, Open-Angle; HLA-DR Antigens; Humans; Immunoenzyme Techniques; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Travoprost

Topical travoprost, a prostaglandin F(2alpha) (PGF(2alpha)) analog, has several well-known side effects, including a darkening of the eyelid and eyelash hypertrichosis, but there are no reports of a deepening of the eyelid superior sulcus associated with its use.. We examined one patient with unilateral normal-tension glaucoma and another with unilateral primary open-angle glaucoma, both of whom were treated with travoprost monotherapy unilaterally for 2 years.. Both patients gradually developed a deepening of the eyelid superior sulcus with hyperpigmentation in the eyelid skin of the treated eye. The disparity between the treated eye and the fellow eye was quite visible. However, the disparity returned to normal after discontinuation of travoprost for 15 months. A deepening of the eyelid superior sulcus is more significant in Asians, who seldom have an eyelid crease or deep sulcus. One proposed mechanism is a mechanical insult to the eyelid causing levator dehiscence. A second possible mechanism is fatty degeneration and reduced collagen fibers in the levator complex caused by the PGF(2alpha) analog. However, the exact mechanism remains to be determined.. A deepening of the eyelid superior sulcus should be considered a possible complication of topical travoprost that can be reversed by discontinuation of the medication.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Eyelashes; Eyelid Diseases; Female; Glaucoma, Open-Angle; Hair Diseases; Humans; Hyperpigmentation; Intraocular Pressure; Male; Travoprost

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Body Weights and Measures; Cloprostenol; Contrast Sensitivity; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lens, Crystalline; Macula Lutea; Tomography, Optical Coherence

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cornea; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Exfoliation Syndrome; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Single-Blind Method; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Exfoliation Syndrome; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Single-Blind Method; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Meta-Analysis as Topic; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost; Treatment Outcome; Visual Fields

To report a new adverse effect related to treatment with bimatoprost.. Case report. A 43-year-old Asian female with bilateral glaucoma was noticed to have bilateral deepening of upper lid sulcus 3 months after beginning treatment with bimatoprost 0.03%.. Bimatoprost was discontinued due to cosmetic reasons, and there was improvement of the lid sulcus deepening bilaterally 4 weeks after stopping the drug.. Deepening of upper lid sulcus is one of the adverse effects related to treatment with bimatoprost. This effect may be more prominent in Asians who have relatively full upper lid sulcus.

Topics: Administration, Topical; Adult; Amides; Antihypertensive Agents; Asian People; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ophthalmic Solutions

To evaluate long-term intraocular pressure (IOP) fluctuation in patients with glaucoma or ocular hypertension treated with bimatoprost or latanoprost.. Post hoc analysis of prospectively collected data from a previously reported multicenter, investigator-masked, randomized clinical trial of bimatoprost and latanoprost.. Patients were treated bilaterally with bimatoprost (n = 133) or latanoprost (n = 136) for six months. IOP measurements were taken at 8 am, 12 pm, and 4 pm at baseline, week 1, and months 1, 3, and 6. Long-term IOP fluctuation during treatment was determined as the standard deviation (SD) of all 12 follow-up measurements.. There was no significant between-group difference in short-term daily IOP fluctuation at baseline. Long-term IOP fluctuation over six months of treatment [mean SD (range SD)] was 1.9 (0.5 to 6.3) mm Hg with latanoprost vs 1.7 (0.5 to 3.9) mm Hg with bimatoprost (P = .050). Latanoprost-treated eyes were more likely than bimatoprost-treated eyes to have long-term IOP fluctuation of > or =3 mm Hg (7.8% vs 2.5% of eyes; P = .009).. Bimatoprost-treated eyes demonstrated less long-term fluctuation in IOP compared with latanoprost-treated eyes in this six-month study. Additional studies are needed to confirm these findings and to determine their impact on glaucomatous progression.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Disease Progression; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Tonometry, Ocular

To compare the effects of latanoprost and bimatoprost on central corneal thickness (CCT).. A total of 188 eyes of 94 patients who were being followed in our hospital's glaucoma clinic and were receiving either latanoprost (55.3%) or bimatoprost (44.7%) monotherapy were recruited for the study. The data were collected prospectively from the patients, who were medicated with bimatoprost or latanoprost, at the initial diagnosis of glaucoma. Measurements were performed at the initial diagnosis, 6th, 12th, and 24th months. All the measurements were carried out by the same doctor between 9 AM and 11 AM, using Goldmann applanation tonometer for intraocular pressure (IOP) and ultrasound biopachymeter for CCT.. There were no significant differences between the patient groups receiving latanoprost or bimatoprost for sex, age, baseline IOP, and CCT. The mean baseline CCT values were 559.5+/-35.3 mum for latanoprost group and 553.4+/-31.7 mum for bimatoprost group. CCT of both groups at 6, 12, and 24 months were significantly thinner when compared with baseline CCT. The percent reduction rates were 1.9+/-2.4% for latanoprost and 2.8+/-1.8% for bimatoprost in the 24th month.. A significant reduction in CCT was observed at the 6th, 12th, and 24th months with latanoprost and bimatoprost. Serial CCT measurements in determining the IOP values may be helpful in the follow-up of prostaglandin analogs.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Microscopy, Acoustic; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular

A retrospective chart review study at a Veterans Affairs hospital evaluated intraocular pressure change after dorzolamide hydrochloride 2% was administered to patients already using travoprost. A literature search found no other study that looked specifically at this combination of drugs.. A chart review of 46 patients at the Veterans Affairs Illiana Health Care System was performed evaluating the intraocular pressures after dorzolamide hydrochloride was added to travoprost. Baseline intraocular pressures were obtained on patients who had been on travoprost at least 4 months. Endpoint intraocular pressures were then obtained from the visit closest to 6 months after the addition of dorzolamide hydrochloride.. An average intraocular pressure reduction of an additional 20.6% was observed after adding only dorzolamide hydrochloride to travoprost.. This study confirmed our clinical observations that dorzolamide hydrochloride added to travoprost is an excellent and safe choice to further lower intraocular pressures.

Topics: Aged; Antihypertensive Agents; Carbonic Anhydrase Inhibitors; Cloprostenol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Follow-Up Studies; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Middle Aged; Ocular Hypertension; Retrospective Studies; Sulfonamides; Thiophenes; Travoprost; Treatment Outcome; Visual Fields

The aim of this study was to study long-term intraocular pressure (IOP) lowering following a switch to bimatoprost in patients with open-angle glaucoma (OAG) not at target IOP while on latanoprost either as monotherapy or as polytherapy with other topical adjunctive agents.. A retrospective review of OAG patients, with <20% IOP lowering from pretreatment baseline while on latanoprost either as monotherapy or in combination with adjunctive agents who were switched to bimatoprost, was conducted. Main outcome measures were mean IOP at 6, 12, and 24 months following the switch to bimatoprost and percent IOP lowering from baseline IOP before the switch.. Records of 30 patients (30 right eyes [OD], 29 left eyes [OS]) were reviewed. Mean IOP preswitch was 23.1 +/- 4.3 mmHg in OD and 22.3 +/- 3.8 mmHg in OS. Postswitch to bimatoprost, IOP was significantly reduced (P < 0.005) at each of the time points studied and patients experienced additional IOP lowering ranging from 17.8 to 22.0% in OD and 15.0-24.0% in OS. Bimatoprost was well tolerated in all but 1 patient.. Significant additional long-term IOP lowering may be achieved by switching to bimatoprost in patients with open-angle glaucoma who are not at target IOP with latanoprost.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Administration Schedule; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ophthalmic Solutions; Pilot Projects; Prostaglandins F, Synthetic; Retrospective Studies; Treatment Outcome

The trabecular meshwork (TM) of glaucomatous eyes is characterized by cell loss, increased accumulation of extracellular matrix (ECM), and cellular senescence. One factor increasingly discussed in the pathogenesis of primary open-angle glaucoma (POAG) is oxidative stress. The goal of this study was to determine whether oxidative stress is able to trigger these typical glaucomatous changes in vitro and whether these oxidative stress-induced TM changes can be reduced by the application of prostaglandin analogues.. Cultured human TM cells were exposed to 200 to 800 microM hydrogen peroxide (H(2)O(2)) for 1 hour. Cell loss was detected by cell-viability assay. Levels of fibronectin and MMP-2 mRNA were determined by real-time PCR analysis. Senescence-associated beta-galactosidase (SA-beta-Gal) activity was investigated by histochemical staining. The effects of prostaglandin analogues and benzalkonium chloride (BAC) on these glaucoma typical TM changes were investigated by preincubation of nonstressed or H(2)O(2)-treated cells with 1:100 diluted commercial solutions of bimatoprost, travoprost, and latanoprost or their corresponding BAC concentrations.. H(2)O(2) induced cell death and fibronectin mRNA expression, but decreased the amount of MMP-2 mRNA. H(2)O(2) increased SA-beta-Gal activity. Additional pretreatment with BAC further increased the typical glaucomatous TM changes in vitro. These effects were reduced by preincubation with prostaglandin analogues in H(2)O(2)-treated and, to a lesser extent, in nonstressed cells. No reduction occurred in the presence of prostaglandin F receptor antagonists in H(2)O(2)-treated cells.. Oxidative stress is able to induce characteristic glaucomatous TM changes in vitro, and these oxidative stress-induced TM changes can be minimized by the use of prostaglandin analogues. Thus, prevention of oxidative stress exposure to the TM may help to reduce the progression of POAG.

Topics: Adult; Amides; Antihypertensive Agents; Apoptosis; Bimatoprost; Cadaver; Cells, Cultured; Cloprostenol; Fibronectins; Gene Expression; Glaucoma, Open-Angle; Humans; Hydrogen Peroxide; Intraocular Pressure; Latanoprost; Matrix Metalloproteinase 2; Middle Aged; Ocular Hypertension; Oxidants; Oxidative Stress; Polymerase Chain Reaction; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; RNA, Messenger; Trabecular Meshwork; Travoprost

In light of concern about the possible relation between the extensive clinical use of prostaglandin analogues and the development of retinal disorders such as cystoid macular edema, this study investigated the influence of topical application of bimatoprost 0.03% on macular thickness and volume in glaucoma patients with phakic eyes.. A total of 40 eyes in 22 patients with primary open-angle glaucoma or normal-tension glaucoma were evaluated in this study. Optical coherence tomography images were taken before initiation of bimatoprost application and after 1, 2, and 3 months of treatment. In addition, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) were measured, and contrast sensitivity tests and fundus examinations were performed. Changes in various parameters, including macular thickness and volume, were analyzed.. BCVA and contrast sensitivity did not change from baseline over the treatment period. IOP declined by 20% to 25% from baseline for 1 month before stabilizing. Macular thickness and volume did not increase significantly during the 3 months.. Topical application of bimatoprost does not induce clinical or structural changes in the macula, at least in glaucoma patients with phakic eyes. Moreover, bimatoprost effectively lowered IOP without causing macular disorders such as cystoid macular edema.

Topics: Administration, Topical; Amides; Antihypertensive Agents; Bimatoprost; Body Weights and Measures; Cloprostenol; Contrast Sensitivity; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lens, Crystalline; Macula Lutea; Male; Middle Aged; Tomography, Optical Coherence; Visual Acuity

To report a patient with glaucoma who developed recurrent herpetic keratitis while using two different prostaglandin analogue ophthalmic solutions.. A 72 year-old male patient with primary open angle glaucoma and a history of herpetic keratitis in the left eye experienced recurrent herpetic keratitis in the left eye after treatment with latanoprost ophthalmic solution. Herpetic flares were controlled after discontinuation of latanoprost. Adding travoprost ophthalmic solution 0.004% to his glaucoma therapy was also associated with a recurrence of herpetic keratitis.. To our knowledge, this is the first case in which travoprost has been associated to recurrent herpetic keratitis. Further, this is the first report in which a patient has a recurrence of herpetic keratitis associated to two different prostaglandin analogues. These findings suggest that patients with recurrent herpetic keratitis associated to a prostaglandin analogue might be predisposed to a flare-up with other prostaglandin analogues.

Topics: Aged; Cloprostenol; Glaucoma, Open-Angle; Humans; Keratitis, Herpetic; Latanoprost; Male; Ophthalmic Solutions; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

To determine the effects of travoprost 0.004% and latanoprost 0.005% treatment on ocular surface in primary open angle glaucoma (POAG) patients.. Clinical, observational prospective study, during 6 months on two groups of patients newly diagnosed with POAG. Group I (10 patients) was treated with travoprost 0.004% and group II (10 patients) was treated with latanoprost 0.005%. The groups were homogeneous about age and sex, exclusion criteria being any ocular or general associated pathology Routine ophthalmic examination was performed before and after treatment. At each examination was performed Schirmer 1 test and break up time test. Conjunctival cytology specimen was taken and goblet cells density evaluated.. There was statistically significant difference in goblet cell density Schirmer 1 test and BUT test before and after treatment (p<0.05). For the both groups the decrease of IOP was similar (from 23.7+/-1.5 mmHg to 15.4+/-1.7 mmHg in group I and from 24.3+/-1.5 mmHg to 15.8+/-1.7 mmHg in group II).. This study showed that travoprost 0.004% and latanoprost 0.005% treatment can have adverse effects on ocular surface and may give rise to dry eye symptoms.

Topics: Aged; Antihypertensive Agents; Case-Control Studies; Cloprostenol; Conjunctiva; Drug Therapy, Combination; Dry Eye Syndromes; Epithelium; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Travoprost

The purpose of this study was to assess the accuracy of the ICare tonometer, using the Perkins applanation tonometer (AT) as the reference, in a sample population being treated with travaprost 0.004% for glaucoma.. Twenty-eight consecutive patients with open-angle glaucoma or ocular hypertension who had been receiving travaprost 0.004% to control elevated intraocular pressure (IOP) were included in the study. IOP was measured in the entire sample with ICare and Perkins AT. The difference between the methods was plotted against the mean to compare the tonometers. The hypothesis of zero bias was examined by a paired t-test. The 95% limits of agreement (LoA) were also calculated.. As previously found in young healthy subjects, ICare showed a tendency to overestimate Perkins IOP measurements by a mean of 3.57 mmHg. The agreement between the two methods is shown by the 95% LoA which was from -9.37 to +2.23 mmHg: 53% of the IOP differences fell within +/-3 mmHg.. The performance of the ICare tonometer in glaucomatous patients being treated with travaprost 0.004% to lower the IOP appears to be similar to that of young healthy patients. The tendency of ICare to overestimate the IOP readings should be considered when the instrument is used in the follow-up of glaucomatous patients.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Equipment Design; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Reference Values; Tonometry, Ocular; Travoprost

To compare the efficacy and cost implications of the use of the intraocular pressure-lowering prostaglandin analogues bimatoprost, travoprost, and latanoprost as fixed-combination therapies with timolol, a beta-adrenergic receptor antagonist.. A decision analytic cost-effectiveness model was constructed. Since no head-to-head studies comparing the three treatment options exist, the analysis was based on an indirect comparison. Hence, the model was based on efficacy data from five randomized, controlled, clinical studies. The studies were comparable with respect to study design, time horizon, patient population and type of end point presented. The measure of effectiveness was the percentage reduction of the intraocular pressure level from baseline. The cost evaluated was the cost of medication and clinical visits to the ophthalmologist. All drug costs were market prices inclusive of value-added tax, and visit costs were priced using official physician fees. Cost-effectiveness analyses were carried out in five European countries: Spain, Italy, United Kingdom, Norway and Sweden. The time horizon for the analyses was 3 months.. The analysis showed that fixed-combination bimatoprost/timolol was more effective and less costly than fixed-combination travoprost/timolol and fixed-combination latanoprost/timolol in three out of the five countries analyzed. In two countries, bimatoprost/timolol was less costly than latanoprost/timolol, and cost the same as travoprost/timolol.. This cost-effectiveness analysis showed that the fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was a cost-effective treatment option for patients with primary open-angle glaucoma. This study was limited by available clinical data: without a head-to-head trial, indirect comparisons were necessary. In the United Kingdom, Sweden, Norway, Italy, and Spain, from a health service viewpoint, bimatoprost/timolol was a slightly more effective as well as less costly treatment strategy when compared to both travoprost/timolol and latanoprost/timolol.

Topics: Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Decision Support Techniques; Drug Therapy, Combination; Europe; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Models, Economic; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Timolol; Travoprost

Topics: Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Gastrointestinal Diseases; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross Reactions; Dermatitis, Allergic Contact; Drug Eruptions; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Instillation, Drug; Latanoprost; Middle Aged; Patch Tests; Prostaglandins F, Synthetic

Persistence with ocular hypotensive medication is important as a long-term outcome, and rates of persistence typically are low. This study assessed restart rates for 3 prostaglandin analogs by determining the percentage of patients who discontinued and then restarted therapy.. Retrospective cohort study of pharmacy claims submitted to a large national administrative claims database.. In all, 4356 patients initiating prostaglandin therapy were identified.. Claims for 3 prostaglandin analogs (bimatoprost, latanoprost, travoprost [index prostaglandin]) submitted between 2001 and 2002 were analyzed. Patients were excluded if they did not have coverage in the plan for the preceding 180 days or had been prescribed any ocular prostaglandin in the prior 180 days.. Persistence was defined as neither discontinuing nor changing the index prostaglandin. The number of current users of the index prostaglandin at day 180 was the sum of patients who persisted with the index prostaglandin plus patients who restarted the index prostaglandin after a discontinuation.. Of the 4356 patients initiating prostaglandin therapy, 2503 (57%) were potential current users (were still plan members and had not switched ocular hypotensive therapies after 180 days). Just over half, (1356/2503 [54%]) were current users, including 879 (35%) who persisted with their index prostaglandin and 477 (19%) who restarted their index prostaglandin. Of patients discontinuing their index prostaglandin, more than half failed to restart any topical therapy (827/1624 [51%]).. Previous studies showing low persistence rates for glaucoma therapy failed to evaluate restarts. Restart analyses are crucial for assessing long-term treatment of chronic diseases such as glaucoma. In general, persistence remains a challenge, and our findings demonstrate the importance of clinicians' identifying patients who are not persistent and encouraging them either to restart or to initiate treatment with an alternative therapy.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Databases, Factual; Drug Prescriptions; Drug Utilization; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost

Topics: Acute Disease; Aged; Antihypertensive Agents; Cloprostenol; Corneal Edema; Female; Glaucoma, Open-Angle; Humans; Iritis; Travoprost

Topics: Administration, Oral; Anti-Bacterial Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Azithromycin; Cloprostenol; Eye Diseases; Glaucoma, Open-Angle; Humans; Macular Degeneration; Ocular Hypertension; Ranibizumab; Recurrence; Risk Factors; Stroke; Trachoma; Travoprost

To perform a chart review to measure the validity of large claims databases in estimating patient cooperation with eyedrop therapy and to assess physician adherence with guidelines for a preferred practice pattern (PPP) using a new metric.. Claims database analysis, chart review, and telephone survey.. From 10,260 persons who were recently prescribed a prostaglandin eyedrop for open-angle glaucoma (OAG), a sample of 300 charts (3650 visits) was selected for detailed abstraction.. Database review of pharmacy refill, diagnostic testing, and visit information, with chart review of a sample of patients from the database and interviews with an overlapping sample of patients and physicians.. The individual patient medication possession ratio (MPR), an index estimating the proportion of time that patients have prescribed drug available for use, frequency of examination findings present in charts, and associations between MPR and physician adherence to a PPP.. Chart data confirm that the claims database accurately identified the specific glaucoma eyedrop prescribed, but often identified long-term OAG patients as being new to treatment. Physicians frequently used billing codes for OAG in patients with normal visual field tests. Physicians varied dramatically in their adherence to the PPP, performing intraocular pressure measurements, disc evaluations and imaging, and visual field tests on 90% of OAG patients, but carrying out gonioscopy, central corneal thickness measurement, and setting of target intraocular pressure (IOP) on half of patients.. Large claims databases permit conclusions regarding patient cooperation with glaucoma eyedrop therapy, but they should be used cautiously in imputing severity of disease and prior treatment history. Physician adherence to practice guidelines varied substantially; thus, scoring systems for physician behavior have promise in measuring outcome improvements related to better care.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Prescriptions; Drug Utilization; Female; Glaucoma, Open-Angle; Guideline Adherence; Health Services Research; Health Surveys; Humans; Insurance Claim Review; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ophthalmic Solutions; Optic Disk; Optic Nerve Diseases; Patient Compliance; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prostaglandins F, Synthetic; Travoprost; United States; Visual Fields

The aim of this study was to determine the effect of prostaglandin analog use on postoperative intraocular pressure (IOP) and treatment success following selective laser trabeculoplasty (SLT).. Records from 113 eyes with open angle glaucoma who underwent SLT were reviewed retrospectively. Eyes were categorized as to whether they were receiving a topical prostaglandin analog (n = 78) or other classes of glaucoma medications (n = 35) before and following SLT. IOP was measured before (baseline) and at 1 h, 1 day, 1 week, and 1 month following SLT.. Baseline IOP (+/-standard error [SE]) did not differ between prostaglandin analog users (18.0 +/- 0.48 mmHg) and nonusers (17.5 +/- 0.71 mmHg). One (1) month after SLT, average IOP decrease (+/-SE) was greater (P < 0.02) among prostaglandin analog users (3.4 +/- 0.4 mmHg), compared to nonusers (1.6 +/- 0.5 mmHg). Also at 1 month, average percent IOP decrease (+/- SE) was greater (P < 0.015) among prostaglandin analog users (16.5 +/- 2.0%), compared to nonusers (7.9 +/- 2.7%). At 1 h, 1 day, and 1 week after SLT, there were no differences in average IOP decrease or percent IOP decrease between prostaglandin analog users and nonusers. The percentage of eyes with a 20% or greater decrease in IOP was greater (P < 0.015) among prostaglandin analog users (44.9%), compared to nonusers (22.9%), 1 month after SLT. Also, 48.7% of prostaglandin analog users had an IOP decrease of 3 mmHg or greater, compared to 31.4% of nonusers, 1 month after SLT (P < 0.05). Retreatment rate among prostaglandin analog users (11.5%) was less (P < 0.005) than nonusers (34.3%).. Prostaglandin analog use during the perioperative period prior to and 1 month after SLT is associated with greater average IOP decrease and percent IOP decrease 1 month postoperatively, compared to eyes not receiving these agents. Prostaglandin analog use is also associated with a greater likelihood of treatment success and a lesser likelihood of requiring retreatment 1 month postoperatively.

Topics: Administration, Topical; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Laser Therapy; Latanoprost; Lipids; Male; Perioperative Care; Postoperative Period; Prostaglandins F, Synthetic; Retreatment; Retrospective Studies; Trabeculectomy; Travoprost; Treatment Outcome

To evaluate the incidence and characteristics of periocular pigmentation with latanoprost versus bimatoprost.. A retrospective, active-controlled comparison of consecutive patients treated with latanoprost or bimatoprost for 12 months evaluating patients to determine the incidence, characteristics, and reversibility of periocular pigmentation.. Periocular pigmentation was found in 1% patients treated with latanoprost and 6% patients treated with bimatoprost within 12 months of beginning treatment (p = 0.004).. This study suggests that periocular pigmentation may develop after treatment with latanoprost or bimatoprost.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eye Color; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Incidence; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Pigmentation Disorders; Prostaglandins F, Synthetic; Retrospective Studies; Skin Pigmentation; Tonometry, Ocular

A 76-year-old man presented with features of bilateral herpes simplex virus (HSV) keratitis. It was found to be recurrence of bilateral HSV keratitis following the use of Bimatoprost eye drops for uncontrolled intraocular pressure in a case of bilateral primary open-angle glaucoma.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Cornea; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Keratitis, Herpetic; Lipids; Male; Recurrence

The aim of this study is to report an adverse systemic response associated with topical bimatoprost therapy.. An otherwise healthy 58-year-old woman with primary open-angle glaucoma was started on bimatoprost drops once a day. Bimatoprost is a structural analog of prostaglandin F2 alpha-ethanolamide (PGF2a), a class of compounds that in systemic form has been associated with alterations in serum lipid levels. The patient subsequently experienced a significant decrease in her high-density lipoprotein (HDL) serum levels, which subsequently returned to normal on discontinuation of bimatoprost.. This is the first published report of a possible association between topical bimatoprost therapy and decreased serum HDL levels. Because of the significantly increased risk of cardiovascular disease and morbidity associated with low HDL levels, further study is strongly indicated.

Topics: Amides; Bimatoprost; Biomarkers; Cloprostenol; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Lipoproteins, HDL; Middle Aged

The objective of this cost-effectiveness analysis is to evaluate cost-effectiveness ratios of the intraocular pressure (IOP)-lowering agents bimatoprost, latanoprost and timolol in five major European countries: France, Germany, Italy, Spain and the UK.. The cost-effectiveness analysis is based on achievement of IOP targets between 13 and 18 mm Hg. Thus, the cost-effectiveness ratios express the costs of having one patient successfully achieving IOP target. The perspective of the analysis is that of the health care sector payer, including costs of medicine and costs of ophthalmologist visits. The time frame is first year of glaucoma treatment. Four treatment strategies are analysed: Timolol as first line with add-on latanoprost or bimatoprost if IOP targets are not met, and latanoprost and bimatoprost as first line with add-on timolol.. In the UK, Spain, Italy and Germany the timolol first with add-on of bimatoprost is the least expensive treatment. This strategy dominates both strategies involving latanoprost (as add-on to timolol or as first line) in these four countries. The incremental cost-effectiveness ratio of bimatoprost first-line therapy versus timolol with add-on bimatoprost varies from each country and target (from 305 pounds sterlings to 43,720 euros per patient). In France the timolol first line and latanoprost add-on is not dominated and is the cheapest alternative. The incremental cost-effectiveness ratio of timolol with add-on bimatoprost versus add-on latanoprost lies between 71 euros and 355 euros per patient depending on target (18 and 13 mm Hg, respectively).. First-line treatment of latanoprost is dominated in all countries. In four out of five countries the timolol first-line therapy with add-on latanoprost is also dominated. Based on this pharmacoeconomic analysis, the most cost-effective strategy seems to be timolol first line with add-on bimatoprost if target is not met after 3 months.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Controlled Clinical Trials as Topic; Cost-Benefit Analysis; Decision Trees; Drug Costs; Economics, Pharmaceutical; Europe; Glaucoma, Open-Angle; Health Care Costs; Humans; Intraocular Pressure; Latanoprost; Lipids; Models, Econometric; Prostaglandins F, Synthetic; Timolol

To assess the diurnal and nocturnal persistency of intraocular pressure (IOP) reduction after omission of up to two doses of once-daily topical travoprost in patients with open-angle glaucoma or ocular hypertension.. Prospective, open-label study.. Twenty subjects underwent three sessions of 24-hour IOP monitoring. The first session occurred before initiating treatment of newly diagnosed patients or after a four-week washout in patients already receiving medical therapy. The second session occurred after four weeks or more of travoprost treatment. The third session was performed 41 to 63 hours after the last travoprost dose.. IOP lowering persisted after omission of one to two doses. Between 41 to 63 hours after the last dose, diurnal IOP reduction was attenuated, but nocturnal IOP reduction sustained.. IOP lowering effect after omission of one to two doses of travoprost is attenuated in the diurnal period but sustained in the nocturnal period, the time corresponding to the highest baseline habitual IOP.

Topics: Aged; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Travoprost

To describe the demographic and clinical characteristics of bimatoprost-induced periocular skin hyperpigmentation in Caucasians.. Retrospective noncomparative case series.. Thirty-seven Caucasian patients (29 female, 8 male) with a diagnosis of primary open-angle glaucoma (n = 28) or ocular hypertension (n = 9) in whom cosmetically noticeable periocular skin pigmentation developed with bimatoprost therapy.. An unbiased examiner performed a retrospective chart analysis of patients in whom periocular skin hyperpigmentation developed after starting bimatoprost therapy. Data collected included patient demographics, diagnosis, medication history, dates of starting and stopping bimatoprost treatment, and subjective assessment of the periocular hyperpigmentation at initial detection and follow-up visits.. Periocular hyperpigmentation was graded using an arbitrary scale from 0 to 3. The number of days to the onset of hyperpigmentation and to pigment resolution was determined and their associations to demographic and other clinical parameters were analyzed.. Patients had variable grades of periocular hyperpigmentation at presentation (mean, 1.27+/-0.50; range, 1-2.5). Bimatoprost-induced periocular hyperpigmentation appeared most frequently between 3 and 6 months after initiation of bimatoprost therapy (277+/-138 days). Resolution of skin hyperpigmentation was noted most frequently between 3 and 12 months (205+/-97 days); however, there was a wide range of 61 to 472 days. Thirty-three of the 37 patients had complete resolution of the periocular hyperpigmentation.. Bimatoprost use is associated with periocular skin hyperpigmentation in Caucasians with variable time of onset. The periocular hyperpigmentation appears gradually, but in this series was completely reversible on discontinuation of bimatoprost.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Drug Administration Schedule; Eye; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Pigmentation Disorders; Prostaglandins F, Synthetic; Retreatment; Retrospective Studies; Skin Pigmentation; Time Factors; Travoprost; White People

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Europe; Glaucoma, Open-Angle; Humans; Latanoprost; Lipids; Prostaglandins F, Synthetic; Timolol

To analyze the matrix-metalloproteinases' activity (MMP-2 and MMP-9) in primary open angle glaucoma patients with indication for filtrating surgery.. A prospective study, 8 months, in the Ophthalmology Department of the Central Military Hospital, with the collaboration of "Victor Babes" Institute. The study was conducted on 27 eyes with primary open glaucoma and that have underwent filtrating surgery. Patients with other ocular or systemic associated conditions were excluded. Patients were distributed in 3 groups, according to their topical treatment with prostaglandin analogs: Group A: 11 eyes with travoprost 0,004%. Group B: 9 eyes with latanoprost 0,005%. Group C: 7 eyes without prostaglandin analogs. The fragments collected during surgery were processed for imunohistochimical analysis for MMPs. It has used the indirect tristadial method: streptavidine-biotin-peroxidase.

Topics: Antihypertensive Agents; Cloprostenol; Drug Therapy, Combination; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; Matrix Metalloproteinases; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Trabeculectomy; Travoprost

To describe the adverse effect of abdominal cramp caused by travoprost ophthalmic solution in a glaucoma patient.. Case report.. A 34-year-old woman reported abdominal cramp on topical application of travoprost ophthalmic solution. Satisfactory dechallenge and rechallenge procedures were performed.. Abdominal cramp occurred approximately 30 minutes after topical application of travoprost on 3 consecutive days. No abdominal cramp developed after substitution of travoprost with latanoprost or normal saline (in the Travatan bottle). Abdominal cramps recurred on rechallenging with travoprost, either in the original Travatan bottle, a latanoprost bottle, or in a Rescula bottle.. Flu-like symptoms (abdominal cramps, malaise and URI) were reported in 4% of patients participating in clinical trials of travoprost but seldom reported postmarketing. Based on the findings of dechallenge and rechallenge procedures, abdominal cramp should be considered a certain adverse effect of travoprost according to the WHO classification.

Topics: Adult; Antihypertensive Agents; Cloprostenol; Colic; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ophthalmic Solutions; Recurrence; Travoprost

The aim of this study was to evaluate the efficacy and the safety of bimatoprost in an outpatient glaucoma practice and to correlate the responsiveness to this treatment with the central corneal thickness.. Our retrospective analysis included 55 consecutive patients (mean age, 66 years). Bimatoprost was administered in monotherapy in 32 patients and in combined treatment in 23. Mean follow-up was 5.5 months. In bilateral treatments (33/55 patients), only one eye (with the more severe defect and/or the higher IOP) was included in the analysis. The patients were considered as responders to bimatoprost when the observed reduction of IOP was > or = 20% and/or at least 3 mmHg compared with the pretreatment IOP. The mean central corneal thickness (CCT) was extrapolated from five consecutive measurements with the ultrasonic pachymeter Pachette.. Overall, the mean IOP was reduced from a pretreatment value of 21.1 mmHg to 17.3 mmHg at the last visit (mean IOP decrease, 3.6 mmHg, or 17%) (p < 0.05). Except for four patients (7.3%) who discontinued bimatoprost secondary to local or systemic adverse effects, ocular tolerance of bimatoprost was excellent in 62%. Moderate conjunctival hyperemia was present in 18%. The mean IOP reduction was 19% in monotherapy and 15% in combined treatments. Concomitantly, the percentage of responders was slightly higher in patients only receiving bimatoprost than in patients receiving bimatoprost associated with other medication (s). In monotherapy, bimatoprost induced a further IOP decrease of 12% compared with a previous association of two medications that did not include a prostaglandin (10 patients). In the 20 patients in whom bimatoprost had replaced another prostaglandin, a further mean IOP reduction of 11% was observed. The frequency of distribution of the responders to bimatoprost was not correlated with CCT (chi2, p > 0.05).. Considering the limits of this study, our results suggested that bimatoprost was effective and well tolerated in most patients. The decrease in IOP and responsiveness to treatment appeared to be slightly higher in monotherapy than in combined treatments, equivalent to a combination of two medications without prostaglandin and equivalent to or slightly higher than other prostaglandins. The degree of responsiveness did not seem to be correlated with CCT.

Topics: Adolescent; Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Amides; Analysis of Variance; Antihypertensive Agents; Bimatoprost; Chi-Square Distribution; Cloprostenol; Cornea; Corneal Topography; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Prostaglandins; Retrospective Studies; Time Factors

Topics: Antihypertensive Agents; Cloprostenol; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Travoprost; Treatment Outcome

To assess the feasibility of an automatic switch of a large number of patients with glaucoma or suspicion of glaucoma from latanoprost to bimatoprost, and to compare the efficacy of the 2 prostaglandin analogs before and after the switch.. Retrospective nonrandomized comparison.. Forty-three thousand four hundred forty-one California patients and 538 patients at one Southern California clinical facility of a nationwide prepaid health maintenance organization (HMO) who were on either prostaglandin between March 2002 and December 2003 (21 months).. Beginning in April 2002, patients on latanoprost were systemically switched to bimatoprost by the HMO pharmacy service after obtaining approval from the entire ophthalmology staff. PART 1: computerized dispensing records of California patients were retrieved. PART 2: medical records of patients at one clinical facility were reviewed.. Rates of switching or switching back from one prostaglandin to another, intraocular pressure (IOP) control, and intolerability.. PART 1: 17847 patients initially received latanoprost. Of them, 84.8% were switched from latanoprost to bimatoprost, and 13.0% were switched back to latanoprost. Twenty-five thousand five hundred ninety-four patients were started on bimatoprost without previous experience with latanoprost. Of them, 8.6% were later switched to latanoprost use instead. Patients who had previous experience with latanoprost had a statistically significantly higher rate of switching back to latanoprost after a period of bimatoprost use when compared with those who had no prior experience with latanoprost (13.0% vs. 8.6%, respectively; P<0.0001). PART 2: 309 patients were switched from latanoprost to bimatoprost. The mean IOP reduction of 0.51+/-2.77 mmHg (95% confidence interval, 0.20-0.82) after the switch was statistically significant (P = 0.001). Forty-one patients (13.3%) had a decrease of >3 mmHg of IOP. The statistical significance of the IOP reduction after the switch remains in the monotherapy group (P = 0.005) but not in the multitherapy group (P = 0.058). Thirty-three patients (10.7%) who were switched from latanoprost to bimatoprost discontinued bimatoprost and resumed latanoprost.. A systematic pharmacy-level switch from latanoprost to bimatoprost in a nationwide HMO achieved a high switch rate, with little switching back. There was a small but statistically significant reduction in mean IOP after the switch. An appreciable proportion of patients switched had a clinically significant reduction of IOP.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; California; Child; Child, Preschool; Cloprostenol; Feasibility Studies; Female; Glaucoma, Open-Angle; Health Maintenance Organizations; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Pharmaceutical Preparations; Prostaglandins F, Synthetic; Retrospective Studies; Treatment Outcome

To investigate light microscopic and ultrastructural changes in bimatoprost-induced skin hyperpigmentation.. Eyelid biopsy specimens from bimatoprost-treated patients and matched controls were examined by light microscopy and transmission electron microscopy. Using an image analyzer, melanin granules were counted on Fontana-Masson-stained sections, and melanosomes were counted on electron micrographs. Immunohistochemical analysis was performed with antibodies against S100 and CD3. Positively labeled cells were counted.. By light microscopy, a marked increase in the number of melanin granules was noted in the bimatoprost-treated specimens. Electron microscopy demonstrated dermal melanocytes with prominent rough endoplasmic reticulum and abundant normal-sized melanosomes in different stages of maturation as compared with control specimens. Furthermore, the keratinocytes of the bimatoprost-treated specimens showed abundant mature melanosomes when compared with controls. Also of note, atypical melanocytes were absent in both specimens. The S100-positive melanocytes were comparable in bimatoprost-treated and control specimens. Few CD3- and CD68-positive cells in the bimatoprost-treated specimens were noted in both groups.. Bimatoprost-induced periocular hyperpigmentation is caused by increased melanogenesis. There was no evidence of melanocyte proliferation or prostaglandin-induced inflammation in the specimens that were examined.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Biopsy; CD3 Complex; Cloprostenol; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Keratinocytes; Lipids; Melanosis; Melanosomes; Middle Aged; S100 Proteins

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Melanosis; Ophthalmic Solutions

The authors evaluated the effectiveness and safety of bimatoprost using an open-label, non-comparative, three-month, community-based surveillance study. Patients (n = 458) with open-angle glaucoma or ocular hypertension received bimatoprost 0.03% ophthalmic solution as monotherapy, replacement therapy or adjunctive therapy. Bimatoprost produced a rapid, significant (p < 0.0001) reduction in intraocular pressure: monotherapy (34.6% reduction), replacement therapy (16.4% reduction); adjunctive therapy (24.1% reduction). Bimatoprost enabled more patients to achieve their pre-defined target intraocular pressure (p < 0.0001), compared to previous treatments, and significantly lowered intraocular pressure, regardless of the patients' baseline pressure level or history of pressure control. Bimatoprost was well-tolerated; the most commonly reported adverse event was conjunctival hyperaemia (19.9%). Most patients and ophthalmologists rated bimatoprost highly, compared to previously used treatments. The authors concluded that bimatoprost is an effective, well-tolerated treatment for lowering intraocular pressure in Thai patients with open-angle glaucoma or ocular hypertension.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Patient Satisfaction; Population Surveillance; Safety; Thailand; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Multicenter Studies as Topic; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

To compare the cost-effectiveness of bimatoprost versus latanoprost for the treatment of glaucoma and ocular hypertension, a cost-effectiveness algorithm was developed to estimate the annual costs and cost per treatment success (cost-effectiveness) for bimatoprost 0.03% QD compared with latanoprost 0.005% QD. Medication costs for the model were abstracted from published sources. Clinical assumptions for the model were based on the treatment success rates from one 3-month controlled clinical trial comparing bimatoprost versus latanoprost (n =119 and 113, respectively), and another 6-month controlled clinical trial comparing bimatoprost versus latanoprost (n=133 and 136, respectively). Treatment success was defined as the percentage of patients achieving various target intraocular pressures. A larger percentage of patients achieved low target IOPs on bimatoprost than on latanoprost. The cost per treatment success for patients who started treatment on bimatoprost monotherapy was less than for patients started on latanoprost, despite the fact that the estimated yearly costs were similar for these drugs. In this model bimatoprost was found to be more cost-effective than latanoprost, given the average wholesale price of these medications and the assumptions of the cost-effectiveness algorithm about clinical success at the 3- and 6-month decision points.

Topics: Algorithms; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Economics, Pharmaceutical; Glaucoma, Open-Angle; Health Care Costs; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic

Topics: Administration, Topical; Amides; Bimatoprost; Cloprostenol; Dermatitis, Allergic Contact; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Middle Aged

To report hypertrichosis and increased pigmentation of vellus hairs of the malar region associated with topical bimatoprost usage.. Interventional case report. In a female Hispanic patient with open-angle glaucoma, hypertrichosis, and increased pigmentation of the vellus hairs of the malar region developed after 8 weeks of unilateral treatment with bimatoprost. Increased growth of eyelashes was also noted.. Bimatoprost was discontinued, with the intention of monitoring for resolution of hypertrichosis. The patient epilated the hair because of poor cosmetic appearance. Two months after epilating the hair, growth did not recur.. Increased hair growth in the malar region can be an early side effect of topical use of ocular bimatoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelashes; Female; Glaucoma, Open-Angle; Humans; Hypertrichosis; Intraocular Pressure; Lipids; Middle Aged; Zygoma

Topics: Amides; Antihypertensive Agents; Bimatoprost; Black People; Cloprostenol; Eyelid Diseases; Glaucoma, Open-Angle; Humans; Hyperpigmentation; Intraocular Pressure; Lipids; Skin Pigmentation

To report poliosis as a side effect associated with topical prostaglandin F(2alpha) (PGF(2alpha)) analogs.. Case series.. Seven patients treated with different topical PGF(2alpha) analogs for primary open angle glaucoma developed bilateral poliosis, either alone or in combination with other adverse effects of PGF(2alpha) analog therapy.. Poliosis is a possible adverse effect of topical PGF(2alpha) analog therapy which is previously unreported. Topical PGF(2alpha) analog therapy should be included in the differential diagnosis of patients with poliosis.

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelashes; Female; Glaucoma, Open-Angle; Hair Diseases; Humans; Hypertrichosis; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Pigmentation Disorders; Prostaglandins F, Synthetic; Travoprost

To report a case of angiographically documented cystoid macula edema occurring after switching a pseudophakic patient from latanoprost to bimatoprost.. Observational case report.. A 68-year-old man developed intense conjunctival hyperemia and cystoid macula edema after switching from latanoprost to bimatoprost 9 months after cataract surgery in an eye at low-risk for this cystoid macular edema.. Bimatoprost was discontinued and diclofenac initiated. After 2 months, visual acuity and ocular hyperemia returned to baseline levels. Fundus examination revealed resolution of cystoid macula edema.. It is possible that pseudophakic eyes that develop intense conjunctival hyperemia associated with ocular hypotensive lipids might be at higher risk for developing cystoid macula edema.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Fluorescein Angiography; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Lipids; Macular Edema; Male; Prostaglandins F, Synthetic; Pseudophakia; Risk Factors

A previously unreported complication of the use of prostaglandin analog medications for glaucoma therapy is described. A patient with monocular open-angle glaucoma had trichiasis, a condition associated with the use of a prostaglandin analog. The patient was treated with radiofrequency cautery and is now asymptomatic. The unmedicated eye remains asymptomatic to date. Increased lash length, thickness, and pigmentation are well-documented side effects of prostaglandin analog glaucoma drops. Physicians must consider this when prescribing these medications for patients with misdirected eyelashes.

Topics: Aged; Antihypertensive Agents; Catheter Ablation; Cloprostenol; Eyelashes; Female; Glaucoma, Open-Angle; Humans; Hypertrichosis; Travoprost

Altered ocular perfusion plays a role in the pathophysiology of normal tension glaucoma. Prostaglandin-like substances are very effective in lowering intraocular pressure. Less data are available regarding the influence of these compounds on ocular perfusion. In the present study the effects of bimatoprost, which has recently been shown to increase the vascular tone of ciliary arteries in vitro, on the blood flow velocity are investigated.. n = 9 eyes from 9 normal tension glaucoma patients were subjected to color Doppler imaging (CDI) before and during a 3 - 5 week therapy with bimatoprost.. Bimatoprost reduces intraocular pressure from 14.0 +/- 0.4 to 11.0 +/- 0.5 mmHg (n = 9; P < 0.001). Systolic as well as diastolic blood flow velocities, resistive index (RI) and pulsatility index (PI), measured by CDI, were unaltered in the presence of bimatoprost.. Bimatoprost does not influence blood flow velocities in the retrobulbar vessels. The in vitro observation of increased vascular tone in the presence of bimatoprost seems not to be relevant for ocular hemodynamics.

Topics: Amides; Bimatoprost; Blood Flow Velocity; Cloprostenol; Eye; Glaucoma, Open-Angle; Hemodynamics; Humans; Intraocular Pressure; Lipids; Ophthalmic Solutions; Prospective Studies; Ultrasonography, Doppler, Color

To evaluate histopathologic signs of conjunctival inflammation in patients with conjunctival hyperemia induced by bimatoprost treatment.. Prospective interventional study.. The study included 15 eyes of 15 patients scheduled for cataract surgery. Patients in the treatment group (n = 9) exhibited trace to moderate conjunctival hyperemia when treated with bimatoprost 0.03% every day for 15 to 30 days before surgery. The control group (n = 6) included untreated patients with no ocular disease other than cataract. Conjunctival biopsies were obtained for histologic evaluation with light microscopy.. Vascular congestion was observed in biopsies from 7 patients (78%) in the bimatoprost group and 5 patients (83%) in the control group. Signs of inflammation were found in biopsies from 2 patients (22%) in the bimatoprost group and 2 patients (33%) in the control group.. Histopathologic signs of inflammation were no more frequent in conjunctival specimens from bimatoprost-treated patients with trace to moderate hyperemia than in those from untreated control subjects.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cataract Extraction; Cloprostenol; Conjunctiva; Conjunctivitis; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Lipids; Prospective Studies

To evaluate the efficacy of travoprost 0.004% monotherapy in patients unsuccessfully treated with latanoprost monotherapy.. Open-label, noncomparative study conducted at US academic and private practice clinics in adult patients with ocular hypertension or primary open-angle glaucoma who required a change in therapy (due to either inadequate efficacy or safety issues) as judged by the investigator. Intraocular pressure (IOP) was measured at entry and 30 days later.. Mean change in intraocular pressure (mm Hg).. Reported here are 488 per-protocol patients from 330 centers who were using latanoprost monotherapy prior to study entry, and who received travoprost monotherapy during the study. Patients had a mean age of 69 years, were approximately two-thirds Caucasian, 60% female, predominantly brown or blue eyes, and 91% were diagnosed as having primary open-angle glaucoma. The mean days in treatment were 31.9 +/- 6.4. Mean IOP at study entry was 21.2 mm Hg. Following travoprost monotherapy, this was reduced by a mean of 3.2 mm Hg to 18 mm Hg (p < 0.0001, paired t-test). There were 21 adverse events reported in the intent-to-treat (ITT) population for an incidence of 3.5%. There were some limitations to the current study including: no washout period, no control therapy, single IOP determinations at the beginning and the end of the study; patient compliance with the initial therapy was not measured, and the study was not masked. This study reflects a real-life situation of what a clinician can expect when he changes a patient from latanoprost monotherapy to travoprost monotherapy.. This study showed that travoprost provided a statistically and clinically significant reduction (p < 0.0001) in IOP of 3.2 mm Hg for patients who had not been successfully treated with latanoprost monotherapy. The results of this trial demonstrate the potential benefit of using travoprost as a replacement therapy in order to ensure adequate IOP control.

Topics: Aged; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

The phenyl-substituted analog of prostaglandin F 2alpha , latanoprost (Xalatan; Pfizer, Inc, New York, NY) is an intraocular pressure (IOP)-lowering drug for use in patients with glaucoma and ocular hypertension. Latanoprost has been shown to stimulate eyelash hypertrichosis and has recently been proposed as a possible treatment for alopecia areata involving the eyelashes. We report a case of hypertrichosis of the eyelashes caused by the prostamide bimatoprost (Lumigan; Allergan, Inc, Irvine, Calif), a new IOP-lowering drug.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelashes; Female; Glaucoma, Open-Angle; Humans; Hypertrichosis; Lipids

To report increased eyelid pigmentation as an adverse side effect associated with topical ocular hypotensive lipids in African Americans.. Interventional case series.. Two African-American patients with open-angle glaucoma are described in whom increased eyelid pigmentation developed 1 month to 5 months after beginning treatment with either latanoprost or bimatoprost.. Latanoprost was discontinued in an African-American patient, and pigmentation gradually diminished by 3 months after cessation of latanoprost. Increased eyelid pigmentation and increased eyelash length were noted in another African-American patient after just 4 weeks on bimatoprost.. An increase in eyelid pigmentation and eyelash growth is a possible complication of topical ocular hypotensive lipid therapy, even in African-American patients. The changes seems to present earlier after bimatoprost treatment then after latanoprost treatment. Cessation of these medications may lead to loss of induced pigmentation.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Black People; Cloprostenol; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Hyperpigmentation; Intraocular Pressure; Latanoprost; Lipids; Middle Aged; Prostaglandins F, Synthetic; Skin Pigmentation

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic

The prostaglandin analogues represent the first option for the treatment of primary open angle glaucoma. The aim of this paper was to evaluate the efficacy and the safety of Travatan în treatment for different type of glaucoma.. It was performed an observational clinical study between November 2002 and March 2003 on 33 patients (62 eyes), who were divided into treatment with Travatan în 4 groups.. The reduction of IOP was between 3.80-7.80 mm Hg, with 70.94% complete success (IOP < 18 mm Hg) and qualified success (IOP < 22 mm Hg) în 88.31% cases.. Travatan was effective as single therapy or adjunctive therapy, with important and stable lowering IOP. The product was safe, well tolerated and easy for administration.

Topics: Adult; Aged; Cloprostenol; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Retrospective Studies; Travoprost; Treatment Outcome

Topics: Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Travoprost

The structure-activity studies that led to the identification of travoprost, a highly selective and potent FP prostaglandin analog, and AL-6598, a DP prostaglandin analog, are detailed. In both series, the 1-alcohol analogs are very effective and are thought to be acting as prodrugs for the biologically active carboxylic acids. The efficacy of amide prodrugs depends on the degree of substitution and the size of the substituents. Selected compounds are profiled in vitro and in vivo preclinically. Clinical studies show that travoprost 0.004% (isopropyl ester) provided intraocular pressure control superior to timolol 0.5% when used as monotherapy in patients with open-angle glaucoma or ocular hypertension. In clinical studies, AL-6598 0.01% provided a sustained intraocular pressure reduction with q.d. application; b.i.d. provided greater intraocular pressure control. The acute and, apparently, conjunctival hyperemia associated with topical ocular AL-6598 can be attenuated while maintaining intraocular pressure-lowering efficacy by formulating with brimonidine.

Topics: Animals; Antihypertensive Agents; Aqueous Humor; Cats; Cloprostenol; Dinoprost; Dose-Response Relationship, Drug; Female; Glaucoma, Open-Angle; Guinea Pigs; Humans; Intraocular Pressure; Macaca fascicularis; Male; Ocular Hypertension; Rabbits; Randomized Controlled Trials as Topic; Receptors, Immunologic; Receptors, Prostaglandin; Safety; Structure-Activity Relationship; Timolol; Travoprost

Topics: Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Drug Evaluation; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins F, Synthetic; Safety; Timolol; Travoprost

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Interactions; Drug Therapy, Combination; Female; Glaucoma, Angle-Closure; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Approval; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lipids; Ophthalmic Solutions; Treatment Outcome