travoprost and Ocular-Hypertension

To assess the comparative efficacy of latanoprostene bunod (LBN), a novel prostaglandin analogue (PGA), to other medications for open-angle glaucoma and ocular hypertension on lowering intraocular pressure (IOP).. A systematic literature review adapted from the Li. A total of 106 trials were included with data for 18 523 participants. LBN was significantly more effective than unoprostone (-3.45 (-4.77 to -2.12)). Although relative effect was not significative, compared with other PGAs, LBN numerically outperformed latanoprost (-0.70 (-1.83 to 0.43)) and tafluoprost (-0.41 (-1.87 to 1.07)), was similar to bimatoprost 0.01% (-0.02(-1.59 to 1.55)) and was slightly disadvantaged by bimatoprost 0.03% (-0.17 (-1.42 to 1.07)). LBN was significantly more efficient than the beta-blockers apraclonidine, betaxolol, brimonidine, brinzolamide, carteolol, dorzolamide and timolol. According to SUCRA, LBN was ranked second after bimatoprost 0.03%, followed by bimatoprost 0.01%.. LBN was significantly more effective than the PGA unoprostone and most of the beta-blockers. Compared with the most widely used PGAs, LBN numerically outperformed latanoprost and travoprost and was similar to bimatoprost 0.01%.

Topics: Amides; Antihypertensive Agents; Bayes Theorem; Betaxolol; Bimatoprost; Brimonidine Tartrate; Carteolol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Network Meta-Analysis; Ocular Hypertension; Prostaglandins A; Prostaglandins F, Synthetic; Timolol; Travoprost

Fixed-combination (FC) therapy is used in primary open-angle glaucoma (POAG) and ocular hypertension (OHT) patients who require more than one medication to reach their target intraocular pressure (IOP). Currently, there are several FC therapies available for the treatment of glaucoma. The FC of latanoprost/timolol (LTFC) is a commonly used FC. Here, we conducted systematic review to compare the IOP-lowering effects of LTFC with other FCs for patients with POAG and OHT.. We searched PubMed, EMBASE, the Cochrane Library, and Web of Science for randomized-controlled clinical trials and cross-over studies. The outcomes were mean IOP and IOP fluctuation after one month of treatment. Meta-analysis was carried out using RevMan (version 5.1) software. After conducting meta-analyses, we rated the quality of each meta-analysis as high, moderate, low, or very low using the "GRADE" system.. We included 16 trials in this meta-analysis. Moderate-quality meta-analysis showed that LTFC had a comparable mean IOP to that of a fixed combination of travoprost and timolol (TTFC) [mean difference (MD): 0.07 mmHg] and a fixed combination of dorzolamide and timolol (DTFC) [MD: -0.31 mmHg], and it also had a comparable IOP-fluctuation effect compared to that of TTFC [MD: 0.13 mm Hg] and DTFC [MD: 0.25 mmHg]. Compared to the fixed combination of bimatoprost and timolol (BiTFC), moderate-quality evidence showed a higher mean IOP in the LTFC group [MD 0.76 mmHg], whereas low-quality meta-analysis showed higher IOP fluctuation [MD 1.09 mmHg] in the LTFC group.. LTFC is as effective as TTFC and DTFC, but worse than BiTFC in controlling mean IOP and IOP fluctuation for POAG or OHT patients. The quality of our meta-analyses was assessed as moderate, with the exception of one low-quality analysis that compared the IOP fluctuation of LTFC and BiTFC.

Topics: Antihypertensive Agents; Bimatoprost; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Sulfonamides; Thiophenes; Timolol; Travoprost; Treatment Outcome

To evaluated and compared the efficacy and safety of 3 prostaglandin analogues (0.005% latanoprost, 0.004% travoprost, and 0.03% bimatoprost) in treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT).. PubMed, Embase, Cochrane library, Web of science, CNKI, Wanfang, and Vip database, published between January 1, 2000 and June 1, 2018, were systematically examined for randomized controlled trials (RCT) based on prostaglandin analogues for POAG or OHT treatment. Statistical analyses including weighted mean difference (WMD) calculation and odds ratio (OR) were performed using Review Manager Software version 5.3.. The 17 studies were included in this analysis (N = 2433 participants) with 1∼12 months' follow-ups. The difference of intraocular pressure (IOP) reduction between latanoprost and travoprost group had not significant; there was significant difference of IOP reduction between latanoprost and bimatoprost group in the third month and sixth month; Travoprost was significantly different from bimatoprost in reducing IOP in the third month. Travoprost revealed an elevated risk of conjunctival hyperemia compared with latanoprost. An elevated risk of conjunctival hyperemia and growth of lashes compared with latanoprost. Bimatoprost shows lower ocular tolerability with higher incidence of side effects such as conjunctival hyperemia.. 0.03% bimatoprost appears more effective following long time use (3 and 6 month post-treatment) for IOP control compared to 0.005% latanoprost, and is more effective compared to 0.004% travoprost after being used for a certain period of time (3 months post-treatment); nevertheless, 0.005% latanoprost is better tolerated in patients with POAG or OHT.

Topics: Bimatoprost; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; 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

To conduct a meta-analysis of randomised clinical trials (RCTs) in order to evaluate the development of conjunctival hyperaemia after the use of latanoprost versus travoprost and bimatoprost, in patients with ocular hypertension or glaucoma.. In order to identify the potentially relevant RCTs, a systematic literature retrieval was conducted in Medline, Embase and Cochrane Controlled Trials Register (1995-April 2007) databases The outcome measure was the appearance of conjunctival hyperaemia during the study. Statistical analyses included the calculation of odds ratio (OR) and its respective confidence interval, along with intertrial statistical heterogeneity. Publication bias was evaluated through a funnel plot, and a sensitivity analysis was also performed.. In total, 13 RCTs involving 2222 patients with ocular hypertension or glaucoma were included, five comparing latanoprost versus travoprost, seven comparing latanoprost versus bimatoprost and one comparing latanoprost versus travoprost and bimatoprost. The combined results showed that latanoprost produced lower occurrence of conjunctival hyperaemia than both travoprost (OR = 0.51; 95% CI 0.39 to 0.67, p<0.0001) and bimatoprost (OR = 0.32; 95% CI 0.24 to 0.42, p<0.0001). No significant heterogeneity was found between the included RCTs. There was no evidence of publication bias. In the sensitivity analysis performed, none of the clinical trials included in this meta-analysis has an important impact in the global estimation of OR.. According to available data, the use of latanoprost is associated with a lower incidence of conjunctival hyperaemia when compared with travoprost and bimatoprost in the treatment of patients with ocular hypertension or glaucoma.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctival Diseases; Female; Glaucoma; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Travoprost

To asses the association of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol, through a systematic review and meta-analysis of clinical trials in patients with glaucoma.. A systematic review of published clinical trials of latanoprost/timolol and other competitors was conducted in Medline, Embasse and Cochrane Controlled Clinical Trials Register, between 2000 and 2007. Statistical analysis included calculation of the odds ratio (OR) with its 95% confidence interval (CI) using the fixed effects model of Mantel-Haenszel and the random effects model of Der Simonian and Laird. To assess the heterogeneity between trials the Cochrane Q test and the I(2) rate were calculated. The conjunctival hyperemia rates obtained were compared with the Chi-square test.. A total of 8 clinical trials comparing latanoprost/timolol fixed combination with different therapeutic options were found. As trial heterogeneity was moderate (Q: 14.64; df=7; p=0.041; I(2)= 52.2%) a random effects model was used. The final OR was 0.47 (CI 95%: 0.24-0.90); p = 0.024. The total conjunctival hyperemia incidence was 2.9% in the latanoprost/timolol group and 7.0% for the competitors (p<0.0001).. The use of a fixed combination of latanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjunctival hyperemia against the other compared options for the treatment of glaucoma.

Topics: Aged; Brimonidine Tartrate; Clinical Trials as Topic; Cloprostenol; Conjunctival Diseases; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Glaucoma; Humans; Hyperemia; Latanoprost; Middle Aged; Ocular Hypertension; Odds Ratio; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiazines; Timolol; Travoprost

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

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 prostaglandin derivatives are thought to lower intraocular pressure (IOP) primarily by increasing uveoscleral outflow. The ocular side effect, hyperemia, appears to occur via a secondary, unrelated mechanism. Variations in the IOP-lowering effect and incidence of hyperemia associated with these drugs are a function of their different chemical structures. Among the currently approved prostaglandin derivatives, hyperemia occurs in as many as 50% of patients treated with travoprost and as few as 5% of patients treated with latanoprost. The side effect of hyperemia may be of concern to the ophthalmologist for at least 2 reasons: hyperemia may compromise the outcome of filtration surgery, and it may represent a cosmetic problem to the patient thereby leading to non-compliance. The extent to which hyperemia may contribute to patient noncompliance and the effect of administration of the prostaglandin derivatives on outcome of filtration surgery remain to be determined. Until more definitive data are available, when selecting a prostaglandin analogue for ocular hypotensive therapy, it seems prudent to choose an agent with a low incidence of hyperemia.

Topics: Administration, Topical; Cloprostenol; Conjunctiva; Glaucoma; Humans; Hyperemia; Incidence; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins; Prostaglandins F, Synthetic; Travoprost

Prostaglandin analogs are a novel class of intraocular-lowering medications used primarily for the treatment of glaucoma. These topical medications reduce intraocular pressure primarily by enhancing uveoscleral outflow. The recent literature has enhanced our understanding of the mechanism of action, efficacy, and safety of these agents and has allowed us to better understand the differences between the three commonly used once-daily medications.

Topics: Administration, Topical; Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins; Prostaglandins F, Synthetic; Safety; 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

Bimatoprost (Lumigan [Allergan, Inc, Irvine CA]) and travoprost (Travatan [Alcon, Ft Worth, TX]) are two new intraocular pressure (IOP)-lowering drugs for use in patients with glaucoma and ocular hypertension. This review evaluates recent studies comparing these new drugs with timolol and with latanoprost. In each study, the statistical analyses support the conclusion that these agents were more effective than timolol and as effective as latanoprost in terms of their ability to reduce IOP. The side effect profiles for bimatoprost, latanoprost, and travoprost were similar, but with statistically higher occurrences of hyperemia and eyelash growth for bimatoprost or travoprost versus latanoprost or timolol.

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

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

Travoprost, a highly selective and potent analogue of the prostaglandin PGF(2)(alpha), has recently been approved and marketed as a topical ocular hypotensive agent for the treatment of ocular hypertension and glaucoma. Following absorption into the eye, the free acid form of travoprost interacts with the endogenous FP prostanoid receptor to enhance aqueous humor outflow and lower intraocular pressure (IOP). Travoprost is distinguished from other marketed prostaglandin analogues in that it is a full agonist at the prostaglandin receptor. It is also highly selective with little or no affinity for other prostanoid or non-prostanoid receptors in the eye. Travoprost provides robust lowering of IOP with little diurnal fluctuation and results in low target pressures in a large percentage of patients. In controlled clinical trials, travoprost 0.004% o.d. used as monotherapy produced greater IOP reduction than timolol 0.5% b.i.d. and equal or greater reduction than latanoprost 0.005%o.d. Travoprost 0.004% was also shown to be an effective adjunctive agent offering an additional 5 - 7 mmHg IOP reduction in patients inadequately controlled on timolol 0.5%. Subgroup analysis of a large Phase III trial revealed travoprost 0.004% to be significantly more effective at lowering IOP in African American patients by almost 2 mmHg compared to non-African Americans. Moreover, a higher percentage of African American patients responded to travoprost 0.004% and reached lower target pressures than with either latanoprost 0.005% or timolol 0.5%. Travoprost is a very stable compound, maintaining its efficacy following exposure to extremely low and high temperatures, repeated freezing and thawing and exposure to light. Throughout all clinical trials, travoprost was found to be safe and well-tolerated with very few (< 5%) discontinuations due to adverse events. Travoprost 0.004% represents a clinically significant advance for the treatment of glaucoma and ocular hypertension, offering superior IOP reduction and diurnal control, especially among African American patients, in a safe, well-tolerated, stable formulation.

Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Glaucoma; Humans; Intraocular Pressure; Ocular Hypertension; Racial Groups; Receptors, Prostaglandin; Timolol; Travoprost

To evaluate the additive intraocular pressure-lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy.. In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (. The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (-5.59 mm Hg (95% confidence interval: -6.2 to -5.0)) than with vehicle + PGA (-2.15 mm Hg (95% confidence interval: -2.7 to -1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (-3.44 mm Hg, (95% confidence interval: -4.2 to -2.7);. BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.

Topics: Adrenergic alpha-2 Receptor Agonists; Aged; Aged, 80 and over; Antihypertensive Agents; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Sulfonamides; Thiazines; Tonometry, Ocular; Travoprost

To compare the effect of two different prostaglandin analogues (Travatan® vs. Xalatan®) on ocular surface parameters.. This study includes 44 eyes of 44 patients with newly diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Patients were randomly divided into two groups and treated with either benzalkonium chloride (BAK)-preserved latanoprost and polyquad-preserved travoprost. Changes in intraocular pressure (IOP) levels and ocular surface parameters including ocular surface disease index (OSDI) questionnaire, tear breakup time (TBUT), ocular surface staining scores, and Schirmer test scores of patients were performed at baseline, 1, 3, 6, and 12 months of treatment and compared.. The age, sex ratio, visual acuity, central corneal thickness, and cup/disc ratio were similar between the groups. A decrease in IOP levels (23.3 ± 2.5 to 15.5 ± 2.3), TBUT (5.5 ± 2.3 to 4.1 ± 1.7 s), Schirmer test values (11.3 ± 5.9 to 8.6 ± 4.7 s), and a worsening in OSDI scores (44.6 ± 15.2 to 55.1 ± 13.1) and staining scores (1.7 ± 1.6 to 2.3 ± 1.8) were observed in all patients in the first month of treatment (p < 0.05, for all). No further worsening was detected during the 1-year follow-up. There was no difference between the groups in terms of alterations in IOP levels and ocular surface parameters.. Travatan® and Xalatan® have a similar effect on IOP levels and ocular surface parameters in patients with POAG and OHT.

Topics: Antihypertensive Agents; Cornea; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

To evaluate the efficacy and safety of travoprost 0.004% versus timolol 0.5% as an initial intraocular pressure (IOP)-lowering medication for ocular hypertension secondary to vitrectomy.. We performed a randomized, controlled, observer-blinded clinical trial in the Eye & ENT Hospital of Fudan University in China. This trial was registered at www.chictr.org.cn (ChICTR1800014942) before patient enrollment. Seventy-nine adults with IOP of 25-45 mmHg secondary to vitrectomy in the latest one month were enrolled and randomized to receive travoprost 0.004% or timolol 0.5%. More drugs were administered to patients with IOP > 25 mmHg during follow-up.. The mean IOP reduction at day 1 was -10.97 mmHg in the timolol group and -15.02 mmHg in the travoprost group (. Travoprost and timolol have similar efficacy and safety for treating ocular hypertension secondary to vitrectomy.

Topics: Female; Humans; Inflammation; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Risk Factors; Single-Blind Method; Timolol; Travoprost; Vitrectomy

To compare the effects of a topical intraocular pressure (IOP)-lowering medication for preventing an IOP increase after cataract surgery in eyes with glaucoma.. Randomized clinical study.. A total of 165 eyes of 165 patients with primary open-angle glaucoma or pseudoexfoliation glaucoma scheduled for phacoemulsification were randomly assigned to 1 of 3 groups to receive each medication immediately postoperatively: 1) prostaglandin F. At 1 hour preoperatively and at the end of surgery, mean IOP did not differ significantly among the groups. Mean IOP increased significantly between 4 and 8 hours postoperatively and then decreased at 24 hours postoperatively in all groups (P < .0001). Mean IOP was significantly lower in the brinzolamide group than in the travoprost or timolol group at 4, 6, and 8 hours postoperatively (P ≤ .0374) and did not differ significantly among groups at 2 and 24 hours postoperatively. The incidence of an IOP spike was significantly lower in the brinzolamide group than in the travoprost and timolol groups (P = .0029).. Brinzolamide reduces the short-term IOP increase after cataract surgery more effectively than travoprost or timolol in eyes with glaucoma, suggesting that brinzolamide is preferable for preventing an IOP spike.

Topics: Aged; Antihypertensive Agents; Carbonic Anhydrase Inhibitors; Cataract; Cataract Extraction; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Postoperative Complications; Prospective Studies; Sulfonamides; Thiazines; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

To determine whether a patient who is non-responder to latanoprost after one month of use should continue using latanoprost or switch to either bimatoprost or travoprost.. Prospective randomized clinical trial. We recruited new patients who were felt to require intraocular pressure reduction. Patients who had≤20% intraocular pressure reduction after one month of latanoprost treatment were randomly assigned to another month of treatment with latanoprost or a switch to bimatoprost or travoprost for an additional month.. Overall, 83 non-responders to latanoprost after one month of treatment were included in the study. Before latanoprost treatment, the mean intraocular pressure was 23.7±4.7mmHg. At randomization on latanoprost, mean intraocular pressure was 21.5±4.5mmHg. One month after the switch of medication, the mean reduction in intraocular pressure was not significantly different between the groups (P=0.148) and was -0.9mmHg, -2.10mmHg and -2.5mmHg, for latanoprost, bimatoprost and travoprost respectively. One month after randomization, 32 (38.5%) of the patients had become responders, with IOP reduction>20%. Of those patients, 9 (31%) were using latanoprost, 13 (41.9%) bimatoprost and 10 (43.5%) travoprost. The number of new responders was similar between the three groups (P=0.584).. There is no added benefit of switching latanoprost to another topical prostaglandin for patients who are initially non-responders. Regression towards the mean and the Hawthorne effect are probably important factors explaining the additional IOP reduction obtained after randomization and explain the result of most switch studies.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Drug Resistance; Drug Substitution; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Tonometry, Ocular; Travoprost; Treatment Failure

To evaluate efficacy and safety of travoprost in pediatric patients with ocular hypertension or glaucoma and demonstrate its noninferiority to timolol.. Patients aged 2 months to <18 years with glaucoma or ocular hypertension were randomized to receive travoprost (0.004%) or timolol eye drops (0.25% for patients aged 2 months to <3 years and 0.5% for patients ≥3 years old) for 3 months in this double-masked, parallel-group study. Intraocular pressure (IOP) was measured and patients were evaluated at 2 weeks, 6 weeks, and 3 months after treatment. Change in IOP from baseline to 3 months was the primary endpoint, and the test of noninferiority was based on a margin of +3.0 mm Hg using the 95% 2-sided confidence interval of the mean change.. Of 157 patients included (mean age, 9.6 years), 77 received travoprost and 75 timolol. All patients experienced a significant reduction in IOP in the study eye at 3 months: the mean IOP change from baseline was -5.4 mm Hg for travoprost; -5.3 mm Hg, for timolol. The mean difference between travoprost and timolol at month 3 was -0.1 mm Hg (95% CI, -1.5 to 1.4 mm Hg). The most common treatment-related adverse events for the travoprost group were ocular hyperemia and eyelash growth. No serious adverse events were reported.. This study found travoprost to be noninferior to timolol in lowering IOP in patients with pediatric glaucoma or ocular hypertension. Travoprost was well-tolerated, and no treatment-related systemic adverse events were reported.

Topics: Adolescent; Antihypertensive Agents; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Equivalence Trials as Topic; Female; Glaucoma; Humans; Infant; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Timolol; Tonometry, Ocular; Travoprost

To assess adherence to treatment with fixed-combination travoprost 0.004%/timolol 0.5% (TTFC) compared with separate containers of travoprost 0.004% and timolol 0.5% (TRAV+TIM; unfixed) using electronic dosing aids.. Randomized, controlled, observer-masked clinical trial.. setting: Two US clinical sites.. Eligible patients were adults diagnosed with open-angle glaucoma or ocular hypertension. Patients (n = 81) were sequentially randomized 1:1 to receive TTFC or TRAV+TIM for 12 months.. TTFC was administered once daily in the morning or evening with a single dosing aid. Patients randomized to TRAV+TIM administered TRAV once daily in the evening and TIM once daily in the morning using separate dosing aids.. Adherence with administered medication, as recorded by the dosing aids.. Mean ± SD patient age was 60 ± 10 years; most patients were male and white. Compared with TRAV+TIM (n = 40), patients receiving TTFC (n = 41) were consistently adherent on a greater percentage of days through month 12 (60% vs 43%). At months 1, 3, 6, and 12, 80% adherence was achieved by 71% vs 38%, 53% vs 30%, 45% vs 16%, and 32% vs 11% of patients receiving TTFC vs TRAV+TIM, respectively. Significantly more patients were adherent on ≥80% of days with TTFC compared with TRAV+TIM (P < .001 to P = .041). Both treatments reduced IOP from baseline, and no safety issues were identified in either group. Ocular hyperemia was the most common treatment-related adverse event (n = 3/group).. Patients receiving TTFC maintained better treatment adherence compared with patients receiving TRAV+TIM through 12 months of on-therapy evaluation. This suggests that, for patients requiring multiple IOP-lowering medications, a fixed combination may provide improved long-term adherence compared with unfixed therapy.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Instillation, Drug; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Patient Compliance; Single-Blind Method; Time Factors; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome

To assess the effect of switching 1 eye to topical travoprost 0.004% preserved with SofZia (TRAVATAN Z solution) in patients who had chronic superficial punctate keratitis (SPK) in both eyes treated with benzalkonium chloride-preserved latanoprost 0.005% (XALATAN).. This was a prospective, randomized, controlled, multicenter, open-label, comparative 3-month follow-up study. Patients with open-angle glaucoma or ocular hypertension who received XALATAN monotherapy for at least 3 months and had SPK in both eyes were enrolled at 9 facilities. For each patient, 1 eye was randomly selected and switched to TRAVATAN Z solution (T-group); the contralateral control eye was treated with XALATAN (X-group). SPK in 5 corneal regions, conjunctival hyperemia, tear breakup time (TBUT), and intraocular pressure (IOP) were examined in a masked manner at baseline, 1 month, and 3 months. Changes in SPK, hyperemia, TBUT, and IOP were compared within treatment groups and between treatment groups.. Fifty-six patients completed the study. The frequency of SPK significantly decreased from baseline in the T-group and the X-group at 1 and 3 months (T-group, P<0.001; X-group, P<0.05). In the T-group, SPK scores were significantly improved in 4 corneal regions, excluding the superior region, at 1 and 3 months (all P<0.05), whereas in the X-group, SPK scores were significantly improved only in the temporal region at 1 month and in the inferior region at 3 months (P<0.05 for both). The total SPK score at 1 and 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0023 and 0.0102, respectively). The SPK score for the superior and central corneal region at 3 months in the T-group was significantly lower compared with the score in the X-group (P=0.0212 and 0.022, respectively). There were no substantial intergroup or intragroup differences in changes from baseline for hyperemia scores, TBUT, or IOP reduction.. Switching therapy from benzalkonium chloride-preserved latanoprost to travoprost preserved with SofZia ameliorated chronic SPK. There were no clinically relevant changes in hyperemia, TBUT, or IOP.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Chronic Disease; Cornea; Dose-Response Relationship, Drug; Drug Substitution; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Keratitis; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost

To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension.. Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial.. setting: Multicenter; 32 sites in the United States.. Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) ≥21 mm Hg and <32 mm Hg while receiving once-daily TRAV monotherapy.. Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks.. Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC+TRAV over vehicle+TRAV was based on statistical significance of a treatment difference favoring BBFC+TRAV.. Mean diurnal IOP at week 6 (least squares mean ± standard error) was 17.6 ± 0.4 mm Hg and 20.7 ± 0.4 mm Hg in the BBFC+TRAV and vehicle+TRAV groups, respectively (between-group difference, -3.2 ± 0.5 mm Hg; P < .0001). Superiority of BBFC+TRAV over vehicle+TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC+TRAV compared with vehicle+TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC+TRAV, 12.8%; vehicle+TRAV, 6.0%).. Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.

Topics: Adrenergic alpha-2 Receptor Agonists; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Sulfonamides; Thiazines; Tonometry, Ocular; Travoprost; Treatment Outcome

PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, -3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, -4.5 to -2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.

Topics: Adrenergic alpha-2 Receptor Agonists; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sulfonamides; Thiazines; Tonometry, Ocular; Travoprost; Visual Acuity

To evaluate some clinically important features of benzalkonium chloride (BAK) toxicity by comparing tafluprost with 0.001% BAK and travoprost preserved with SofZia applied to the ocular surface of the eyes with glaucoma.. This was a prospective, randomized, observer unmasked, multicenter crossover trial. A total of 195 patients were randomized and 174 patients completed the study at 19 clinics between November 2011 and August 2012. Topical BAK-preserved tafluprost or SofZia-preserved travoprost was newly administered or continued. Superficial punctate keratopathy (SPK), tear break-up time (BUT), the conjunctival hyperemia score, and intraocular pressure (IOP) were compared at the baseline visit, 4, and 12 weeks after the start of therapy. The eye drops were switched to another eye drop after 12 weeks of observation.. The total SPK and conjunctival hyperemia scores were significantly lower in the tafluprost compared with those in the travoprost phase (both P=0.038). There were no significant differences in the SPK scores of the superior area (P=0.679), central area (P=0.089), inferior area (P=0.090), and tear BUT (P=0.271). The IOP-lowering effects were similar (P=0.155).. SPK, hyperemia score, and tear BUT while using tafluprost with 0.001% BAK were not inferior compared with those caused by travoprost with SofZia.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cross-Over Studies; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Travoprost

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

Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK).. This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ≤18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study.. All enrolled patients were included in the analysis (n = 191); the majority of patients (90.6 %, n = 173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P < 0.001 for both). A greater percentage of patients achieved a target IOP of ≤18 mmHg at week 6 (93.1 %; n = 163/175) and week 12 (93.3 %; n = 166/178) compared with baseline (89.5 %; n = 171/191). There was a 10.5 % increase in the percentage of patients with "none/trace" amounts of hyperemia. Most patients preferred the study medication (81.5 %; n = 141/173) and were confident that they would adhere to their preferred medication (90.8 %; n = 157/173). No serious AEs were reported, and eye irritation (3.7 %; n = 7/191) was the most common treatment-related AE.. Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues.. ClinicalTrials.gov identifier, NCT01510145.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Conjunctival Diseases; Corneal Diseases; Drug Substitution; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Young Adult

Improving adherence to ocular hypertension (OH)/glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage. The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy.. A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted. Patients with OH/glaucoma attending a glaucoma clinic and starting treatment with travoprost were approached. Participants were randomised into two groups and adherence was measured over 8 months, using an electronic monitoring device (Travalert® dosing aid, TDA). The control group received standard clinical care, and the intervention group received a novel glaucoma education and motivational support package using behaviour change counselling. Cost-effectiveness framework analysis was used to estimate any potential cost benefit of improving adherence.. Two hundred and eight patients were recruited (102 intervention, 106 control). No significant difference in mean adherence over the monitoring period was identified with 77.2% (CI, 73.0, 81.4) for the control group and 74.8% (CI, 69.7, 79.9) for the intervention group (p = 0.47). Similarly, there was no significant difference in percentage intraocular pressure reduction; 27.6% (CI, 23.5, 31.7) for the control group and 25.3% (CI, 21.06, 29.54) for the intervention group (p = 0.45). Participants in the intervention group were more satisfied with information about glaucoma medication with a mean score of 14.47/17 (CI, 13.85, 15.0) compared with control group which was 8.51 (CI, 7.72, 9.30). The mean intervention cost per patient was GB£10.35 (

Topics: Aged; Aged, 80 and over; Analysis of Variance; Antihypertensive Agents; Cloprostenol; Counseling; Female; Glaucoma; Health Care Costs; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Patient Education as Topic; Patient Satisfaction; Patient-Centered Care; Travoprost

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

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 compare the intraocular pressure (IOP) lowering effect of 0.004% travoprost and 2% carteolol in patients with ocular hypertension (OHT) after laser peripheral iridotomy (LPI) or trabeculectomy in primary angle-closure glaucoma (PACG).. Clinical case control trial. 52 consecutive PACG patients (52 eyes) with IOP > 21 mm Hg (1 mm Hg = 0.133 kPa) after LPI or trabeculectomy were enrolled. 24 patients received topical application of 0.004% travoprost (once daily) and 28 received 2% carteolol (twice daily). IOP lowering effect of travoprost and carteolol before and after treatment was measured by Goldmann tonometer and compared using t-test. The relationship of IOP lowering effect and the degree of angle open was performed by gonioscope and analyzed using Spearman rank correlation.. Compared with pre-treatment, the IOP was significantly reduced in 24 patients (24 eyes) in 0.004% travoprost group [pre-treatment: (24.67 ± 3.08) mm Hg, post-treatment: (18.58 ± 2.71) mm Hg; t = 6.600, P < 0.05], while significantly reduced in 28 patients (28 eyes) received 2% carteolol [pre-treatment: (23.57 ± 1.60) mm Hg, post-treatment: (19.57 ± 1.60) mm Hg; t = 5.130, P < 0.05]. 0.004% travoprost group is more significant in both quantity and percentage of IOP lowering than 2% carteolol (t = 2.533, 2.532; P < 0.05). There was no correlation between the IOP lowering effect and the degree of angle open in both groups (0.004% travoprost r = 0.145, 0.009; P > 0.05; 2% carteolol r = 0.090, 0.183, P > 0.05).. Both of 0.004% travoprost and 2% carteolol reduce IOP in patients with OHT after LPI or trabeculectomy in PACG. 0.004% travoprost is more effective than 2% carteolol in IOP lowering. However, the decrease of IOP is not acted through the alteration of anterior chamber angle in both study groups.

Topics: Aged; Aged, 80 and over; Carteolol; Cloprostenol; Female; Glaucoma, Angle-Closure; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Postoperative Complications; Trabeculectomy; 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 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 determine if adherence and convenience of once-daily glaucoma medication is greater in the morning or the evening.. Prospective, randomized crossover treatment trial.. Thirty patients newly diagnosed with glaucoma or ocular hypertension requiring intraocular pressure (IOP) reduction were started on travoprost eye drops and randomized to either morning or evening administration for 1 month. They were then crossed over to the opposite dosing schedule for the following month. Adherence was monitored using an automated dosing aid.. Adherence was compared between morning versus evening dosing and first versus second month dosing. Demographic characteristics were obtained, treatment effect was measured, and patients completed a post-study questionnaire regarding the convenience of the 2 dosing regimens.. Patient adherence overall was good (89.3%). There was no statistically significant difference (P=0.07) in adherence between morning dosing (90.9%) and evening dosing (87.3%). Adherence in the first month (91.7%) was superior to the second month (86.5%). There was no significant difference in IOP response between morning and evening dosing. Patients found morning dosing more convenient than evening dosing.. Early adherence to treatment with a prostaglandin analogue is good, but patients prefer morning administration to evening administration. This may lead to greater adherence with morning administration, particularly among men. Adherence decreases from the first to second month after initiation of treatment. IOP response to this treatment is not significantly affected by morning versus evening administration.

Topics: Administration, Topical; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cross-Over Studies; Drug Chronotherapy; Female; Glaucoma; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Surveys and Questionnaires; Travoprost

To compare the daily versus the alternate day use of travoprost 0.004% in lowering the intraocular pressure (IOP) in patients with ocular hypertension.. Fourteen patients with ocular hypertension in both eyes have been randomly assigned to receive travoprost 0.004% once a day in 1 eye and once every other day in the other eye. The main outcome measure was change in the mean of the IOPs measured at 9:00 AM, and 4:00 PM between baseline (before treatment) and measurement of IOPs at 1, 2, 4, 8, and 12 weeks after treatment.. After 3 months of treatment, daily use of travoprost 0.004% significantly reduced IOP (mean±standard error of mean) by 6.1±0.5 mmHg (P<0.001) and alternate day use by 5.9±0.3 mmHg (P< 0.001) adjusted from an overall baseline of 24.3±0.5 mm Hg. The difference in the IOP-lowering effect was not statistically significant (P<0.05).. Alternate day use of travoprost 0.004% was as safe and effective as its daily use in lowering the IOP in patients with ocular hypertension.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Female; Gonioscopy; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

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

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

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 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 study compliance in the medical treatment of glaucoma, its possible association with other factors, and quality of life of patients with glaucoma.. Longitudinal prospective study of 60 patients with ocular hypertension or glaucoma who were treated with travoprost, or with a fixed combination of travoprost/timolol nightly. All subjects were given a Travalert(®) dosing aid and were reviewed after one and four months. Strict and relative compliance data were collected on each visit. The relationship between compliance and other variables was studied using univariate analysis. To analyse quality of life, patients were given self-assessment STAI anxiety questionnaires after the first and last visits.. Relative compliance for the four months was significantly greater than the strict compliance (P=.001). In the group of least compliance the number of patients on treatment with combination therapy was significantly higher than those on monotherapy. In the lost cases, the number of men was significantly higher than women. No association was found in the other variables. The anxiety was similar to that in the normal population.. Compliance is very important in the treatment of glaucoma, and our study provides objective data through the use of Travalert dosing aid with relative compliances of 70%. Patients with combined therapies have lower compliance than those on monotherapy.

Topics: Administration, Ophthalmic; Aged; Anxiety; Cloprostenol; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Glaucoma; Humans; Instillation, Drug; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Quality of Life; Reminder Systems; Surveys and Questionnaires; 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

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 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 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

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 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 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

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 the 24-h IOP reductions induced by latanoprost, travoprost, and bimatoprost in eyes with exfoliation syndrome (XFS) associated with ocular hypertension (OH).. This was a prospective, randomized, single masked, and parallel design study with 15 patients in each treatment group. After washout of any previous medications, each patient underwent a baseline 24-h IOP curve testing at 0600, 0900, 1200, 1500, 1800, 2100, and at 2400 (midnight) hours. Patients were then randomized to receive latanoprost, travoprost, or bimatoprost once a day for 3 months. The 24-h curve testing was repeated at first week, and first and third months.. Maximal and minimal IOP was recorded at 0600 and 1800-2100 hours. There was no significant difference among treatment groups at any time-point except for the first week. At the first week, the travoprost group had significantly lower IOP levels than the latanoprost and bimatoprost groups. All medicines significantly lowered 24-h IOP from baseline (P=0.001 for each). Although there was no significant difference in IOP reduction among groups at first week and first month, bimatoprost reduced the 24-h IOP (7.9+/-1.4) more than travoprost (6.6+/-0.5) at the end of the third month (P=0.003). The mean 24-h range of IOP was lowest with travoprost in all visits, and between-group differences was significant for travoprost vslatanoprost (P=0.007) and travoprost vsbimatoprost (P=0.001) at the third month.. Latanoprost, travoprost, and bimatoprost were effective in reducing the 24-h IOP in patients with XFS and OH, and more research is required with a larger study.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Exfoliation Syndrome; Female; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Travoprost; Treatment Outcome

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 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 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

Conjunctival hyperaemia and ocular adverse effects induced by a single dose of 0.004% travoprost in healthy subjects were evaluated. A randomized, double-blind cross-over placebo controlled study was done. Conjunctival hyperaemia was evaluated clinically at 12, 24, 36 and 72 hours after dosing and volunteers reported all ocular adverse effects. 15 out of 20 subjects (70%) dosed with travoprost compared with 2 out of 20 (10%) dosed with placebo developed clinically moderate hyperaemia. However, significant difference in hyperaemia in the two groups occurred only at 24 hours (P < 0.048). The hyperaemia cleared by 72 hours. Travoprost may cause significantly short-term conjunctival hyperaemia even after a single dose in the eyes of healthy African subjects.

Topics: Adult; Antihypertensive Agents; Cloprostenol; Conjunctival Diseases; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Follow-Up Studies; Humans; Hyperemia; Male; Nigeria; Ocular Hypertension; Ophthalmic Solutions; Prognosis; Prospective Studies; Reference Values; Risk Factors; Travoprost

Intraocular pressure (IOP) fluctuation over 24 hours is an independent risk factor for glaucoma progression. Nighttime lOP measurement is not routine practice.. The aim of this study was to predict, using a Bayesian network (BN), the likelihood of a nighttime IOP peak >18 mm Hg based on daytime measurements.. A pooled analysis was conducted using a BN. Data from 3 clinical trials of adult patients with glaucoma or ocular hypertension were used. IOP values at 0800, 1200, 1600, and 2000 hours were dichotomized according to the 18-mm Hg threshold. Patients' lOPs were assessed from the pretreatment washout periods and during latanoprost or travoprost treatments. A BN was constructed to study associations between daytime and nighttime IOP values, and prostaglandin analogue IOP control adjusted for trial. The nighttime IOP peak was defined as the maximum IOP value between 2400 and 0400 hours.. The study identified 382 daily IOP vectors (6 measures per day, every 4 hours for 24 hours; pretreatment, 208; latanoprost, 73; travoprost, 101). Based on the BN, IOP at 0800 hours was associated with IOP at 1200 hours, which was also associated with the IOP at 1600 hours. IOP at 2000 hours was predicted by the IOPs at 1200 and 1600 hours. The nighttime IOP peak was associated with IOP >18 mm Hg at 1200 and 2000 hours. The percentage of patients with controlled IOP at 1200 and 2000 hours was higher in those receiving travoprost than in those receiving latanoprost. Travoprost was also associated with an increased probability of controlling nighttime IOP values >18 mm Hg (travoprost, 76.9%-77.5% vs latanoprost, 66.7%-67.9%). Daily IOP fluctuations were not found to be associated with nighttime IOP peak.. Daytime IOP measurements are highly intercorrelated. According to this BN, IOP at 1200 and 2000 hours are more strongly associated with the nighttime IOP peak than other IOP measurements. BN can estimate the risk of a nighttime IOP peak >18 mm Hg. Daytime IOP control was important for nighttime IOP control. These findings require validation in a clinical setting.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bayes Theorem; Circadian Rhythm; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Models, Biological; Ocular Hypertension; Prostaglandins F, Synthetic; Reproducibility of Results; Travoprost; Treatment Outcome

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

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

The aim of this study was to evaluate the effect of preoperative topical latanoprost, bimatoprost, and travoprost administration on postoperative intraocular pressure (IOP) after phacoemulsification and posterior chamber intraocular lens (PC IOL) implantation.. This prospective, randomized, double-masked study included 120 eyes of 120 consecutive, normotensive, uncomplicated cataract patients having phacoemulsification surgery with PC IOL implantation. They were randomized into 1 of 4 treatment groups, each of which had 30 patients. Two (2) h before the surgery, the patients received 0.005% latanoprost (Group 1), 0.004% bimatoprost (Group 2), 0.03% travoprost (Group 3), or placebo (Group 4, artificial tears). IOP was measured at preoperative, 4, 8, and 24 h postoperative with a Goldmann applanation tonometer. The anterior chamber was examined postoperatively 24 h for levels of cell and flare using slit-lamp biomicroscopy.. The preoperative mean IOP was not statistically significant different among the four groups. In Groups 1 and 3, the mean IOP at 4, 8 and 24 h were significantly lower than the control (Group 4; P < 0.05). However, in Group 2, there was no significant difference in IOP during the study period, compared to the control (Group 4; P > 0.05). In addition, the mean postoperative IOP at 24 h in Groups 1 and 3 were significantly lower than the preoperative IOP (P < 0.05). No severe anterior chamber reaction was observed in any group.. Our findings show that a single-dose topical of latanoprost and travoprost can prevent early postoperative IOP elevation after phacoemulsification surgery without any sideeffects.

Topics: Administration, Topical; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Humans; Intraocular Pressure; Latanoprost; Lens Implantation, Intraocular; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Phacoemulsification; Postoperative Complications; Prospective Studies; Prostaglandins F, Synthetic; Travoprost

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

The objective of this study was to assess the hypotensive efficacy of timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2% ophthalmic solution, administered in conjunction with travoprost 0.004%, in patients with primary open-angle laucoma (OAG) or ocular hypertension (OHT) whose intraocular pressure (IOP) did not meet the treatment target using travoprost 0.004% monotherapy.. This was a randomized, comparative, investigator-masked study. Patients with OAG or OHT treated with travoprost 0.004% monotherapy were randomized to receive 1 of the 3 adjunctive therapies (timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2%), 1 drop BID in each randomized eye, in addition to 1 drop QD of travoprost for a period of 4 weeks. IOP was measured on days 0 (travoprost 0.004%) and 28 (travoprost 0.004% and adjunctive treatment). Adverse events were monitored on days 0 and 28 by patient interview.. Twenty-nine patients with OAG (46 eyes) and 3 patients with OHT (6 eyes), with a total of 52 eligible eyes, completed the study; 28 eyes were from male patients and 24 were from female patients. In addition to continuing travoprost treatment, 20 eyes received timolol, 16 eyes received brinzolamide, and 16 eyes were treated with brimonidine. There were no significant differences among the groups in the mean (SD) IOP at baseline on day 0 (19.0 [4.1], 17.2 [3.5], and 17.0 [3.1] mm Hg, respectively; P=NS). On day 28, the reduction in mean (SD) IOP in eyes treated with brimonidine tartrate 0.2% was significantly smaller (2.3 [1.8] mm Hg vs 3.9 [1.8] mm Hg [P=0.01]) and the mean (SD) percentage reduction in IOP was significantly smaller (13.4% [9.1%] vs 20.2% [7.5%] [P=0.01]) when compared with timolol maleate 0.5%, and likewise when compared with brinzolamide 1% (4.0 [2.1] mm Hg [P=0.02] and 22.7% [8.6%] [P=0.006], respectively). The group treated with brinzolamide was associated with a similar reduction in IOP to timolol (P=NS for both mean [SD] IOP and percentage reduction in IOP compared with timolol monotherapy). Barring the occasional conjunctival hyperemia, which was excluded as an adverse event for the purposes of this study, no adverse events were recorded.. Brinzolamide 1% and timolol maleate 0.5% treatment were both associated with a significantly greater reduction in IOP compared with brimonidine 0.2% when administered as a nonfixed adjuvant to travoprost 0.004% in the treatment of patients with OAG and OHT whose IOP was inadequately controlled with travoprost monotherapy. All treatments were well tolerated.

Topics: Adrenergic alpha-Agonists; Adrenergic beta-Antagonists; Aged; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Quinoxalines; Sulfonamides; Thiazines; Timolol; Travoprost

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

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 primary objective of this study was to determine the intraocular pressure- (IOP) lowering efficacy over two consecutive 24-h periods of travoprost 0.004% ophthalmic solution (Travatan) compared to latanoprost 0.005% (Xalatan) dosed once daily in patients with primary open-angle glaucoma or ocular hypertension.. This was a double-masked trial conducted at the Hospital Clínico San Carlos, Madrid, Spain. The primary objective of this study was to determine the IOP lowering efficacy of travoprost and latanoprost. During the eligibility visit, patients' IOP was measured throughout two consecutive 24-h periods every 4 h. Patients were then randomized to travoprost or latanoprost (one drop at 8 p.m. daily for 2 weeks). Sixty-two patients were randomized (travoprost n = 32; latanoprost n = 30). IOP was measured at week 2 every 4 h throughout two 24-h periods. All measurements were taken in both supine and sitting positions with the aid of Perkins applanation tonometry. Limitations of the study include a small sample size (due to the difficulty in recruiting patients in a study of this type) which enrolled only Caucasian patients and a short study duration. However, with 25 subjects per group, there was at least 90% power to detect a mean IOP change from baseline of 2.9 mmHg and 80% power to detect a difference of 2.5 mmHg between treatments.. Patients on travoprost therapy showed lower mean IOP levels than those on latanoprost. This difference was statistically significant (p < 0.05) at 12, 16, 20, 24, 36, 40, and 48 h after the last dose for the supine position. The mean IOPs in the supine position throughout the first and the second 24-h period of the week 2 visit as well as for the 48-h visit were statistically lower (p < 0.05) for the travoprost group. Adverse events were mild and included hyperemia and corneal staining. Travoprost and latanoprost were both well tolerated.. Mean IOP values were significantly lower for patients on travoprost for the majority of time points in the supine position.

Topics: Aged; Circadian Rhythm; Cloprostenol; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; 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 the intraocular pressure (IOP) lowering effect of travoprost and brinzolamide within the first 24 h after phacoemulsification cataract surgery.. This prospective, randomized, double-masked, controlled study comprised 90 eyes of 90 consecutive patients with senile cataract who had uneventful phacoemulsification surgery. Eyes in the first group received travoprost 0.0015%, second group received brinzolamide 1%. Eyes in the third group received balanced salt solution and were used as control. One drop was instilled immediately after surgery. IOP was measured 24 h preoperatively, 6 and 24 h postoperatively. Analysis of variance, Student's-t and chi2-tests were used for statistical analyses.. Preoperatively IOP was not significantly different among the three groups (P = 0.653). At 6 and 24 h postoperatively IOP was lower in both travoprost and brinzolamide group when compared to control group (P = 0.018 and 0.015 at 6 h, P = 0.010 and 0.007 at 24 h between travoprost and brinzolamide group was not significant (P = 0.744 at 6 h and P = 0.672 at 24 h).. Both travoprost and brinzolamide significantly lowered IOP after small incision phacoemulsification cataract surgery within the first 24 h without any side effect.

Topics: Adult; Aged; Carbonic Anhydrase Inhibitors; Cloprostenol; Double-Blind Method; Female; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Phacoemulsification; Postoperative Care; Prospective Studies; Sulfonamides; Thiazines; Travoprost

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 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 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

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

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

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

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

The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy.. A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6.. The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7  (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001).. PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively.. European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.

Topics: Adult; Antihypertensive Agents; Bimatoprost; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prospective Studies; Prostaglandins A; Prostaglandins F; Timolol; Travoprost

To compare ocular redness score calculated automatically between glaucoma patients and healthy controls, and to assess the associations between this score and both demographical and clinical characteristics.. Glaucoma patients under different topical medications and matched controls were enrolled in this observational cross-sectional study. The Keratograph 5M (Oculus Optikgeräte GmbH) was used to automatically measure 5 redness scores: global; nasal bulbar; temporal bulbar; nasal limbal; temporal limbal. The Student. Ocular redness was significantly higher in patients with glaucoma compared to control subjects. The number of active principles and the use of PAs, CAIs and AAAs were associated with higher redness scores.

Topics: Antihypertensive Agents; Bimatoprost; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

Topics: Aged; Glaucoma, Open-Angle; Headache; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Retrospective Studies; Travoprost

The distribution of prostaglandin-associated periorbitopathy (PAP) graded using the Shimane University PAP Grading System (SU-PAP) among glaucoma/ocular hypertension subjects using a topical FP or EP2 receptor agonist was reported. A 460 consecutive 460 Japanese subjects (211 men, 249 women; mean age ± standard deviation, 69.9 ± 14.5 years) who had used either a FP agonist (0.005% latanoprost, 0.0015% tafluprost, 0.004% travoprost, 0.03% bimatoprost, or fixed combinations of these) or EP2-agonist (0.002% omidenepag isopropyl) for more than 3 months in at least 1 eye were retrospectively enrolled. Age, sex, prostaglandin, intraocular pressure (IOP) measured by Goldmann applanation tonometry (IOPGAT) and iCare rebound tonometry (IOPRBT), difference between IOPGAT and IOPRBT (IOPGAT-RBT), PAP grade, and PAP grading items were compared among groups stratified by PAP grade or prostaglandins. Of the study patients, 114 (25%) had grade 0 (no PAP), 174 (38%) grade 1 (superficial cosmetic PAP), 141 (31%) grade 2 (deep cosmetic PAP), and 31 (7%) grade 3 (tonometric PAP). The IOPGAT was significantly higher in grade 3 (17.5 ± 5.4 mm Hg) than grades 0 (15.0 ± 5.1 mm Hg, P = .032) and 1 (14.5 ± 4.2 mm Hg, P = .008), and the IOPGAT-RBT was significantly higher in grade 3 (5.8 ± 3.2 mm Hg) than the other 3 grades (1.3-1.9 mm Hg, P < .001 for all comparisons); the IOPRBT was equivalent among the 4 grades. The PAP grade was significantly higher associated with travoprost (2.0 ± 0.8) and bimatoprost (2.0 ± 0.7) than latanoprost (1.0 ± 0.8, P < .001 for both comparisons) and tafluprost (1.0 ± 0.7, P < .001 for both comparisons), but significantly lower associated with omidenepag (0.0 ± 0.0, P < .001 for all comparisons) than the other 4 prostaglandins. Multivariate analyses showed older age (standard β = 0.11), travoprost (0.53, referenced by latanoprost) and bimatoprost (0.65) were associated with higher PAP grades, while tafluprost (-0.18) and omidenepag (-0.73) were associated with lower PAP grades. The PAP graded using SU-PAP reflects the degree of overestimation of the IOPGAT and different severities of PAP among the different prostaglandins. SU-PAP, the grade system constructed based on the underlining mechanisms of PAP, is a simple grading system for PAP that is feasible for use in a real-world clinical situation.

Topics: Age Factors; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Manometry; Middle Aged; Ocular Hypertension; Orbital Diseases; Prostaglandins F; Prostaglandins, Synthetic; Retrospective Studies; Severity of Illness Index; Sex Factors; Travoprost

Preservatives in glaucoma medications have been associated with ocular toxicity. We compared ocular signs and symptoms in patients with open-angle glaucoma or ocular hypertension treated in monotherapy with preserved or preservative-free prostaglandin analogues.. Observational cross-sectional clinical study in real life. 82 patients treated for at least 6 months with prostaglandin analogue were assessed for intraocular pressure, ocular symptoms and ocular signs including conjunctival hyperaemia, tear break-up time and tear meniscus height measured using objective and non-invasive methods (OCULUS Keratograph 5M). Patients presenting with symptoms of ocular toxicity with preserved prostaglandin analogues were switched to preservative-free latanoprost, and a second assessment was processed 6 months after.. At inclusion, 30 (36.6%) patients were treated with preservative-free latanoprost, 25 (30.5%) with preserved latanoprost, 16 (19.5%) with preserved travoprost and 11 (13.4%) with preserved bimatoprost. Patients treated with preservative-free latanoprost reported significantly less ocular symptoms upon instillation (mainly burning) and between instillations than patients treated with preserved prostaglandin analogues. The mean conjunctival hyperaemia (limbal + bulbar) was significantly lower with preservative-free latanoprost (2.08 ± 0.55) compared to preserved latanoprost (2.50 ± 0.7, p = 0.0085), preserved travoprost (2.67 ± 0.82, p = 0.0083) and preserved bimatoprost (2.68 ± 0.67, p = 0.0041). There were no relevant between-group differences in mean tear meniscus height and break-up time. Ocular symptoms and conjunctival hyperaemia improved when preserved prostaglandin analogues were switched to preservative-free latanoprost for 6 months while intraocular pressure reduction was maintained.. Overall, this study suggests a better subjective and objective ocular tolerance when patients were treated with preservative-free latanoprost than with other preserved prostaglandin analogues monotherapy. Switching to preservative-free latanoprost maintained intraocular pressure at the same level as preservative prostaglandin analogue, but improved ocular surface tolerance.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Conjunctival Diseases; Cross-Sectional Studies; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins, Synthetic; Tonometry, Ocular; Travoprost

The primary goal is to determine if the intraocular pressure reducing effect of generic Sandoz travoprost is equivalent to that of brand-name Travatan Z. The secondary goal is to determine if generic Sandoz travoprost is as well tolerated as Travatan Z.. This prospective randomized crossover trial allocated 76 patients with primary open-angle glaucoma, normotensive glaucoma, or ocular hypertension in a 1:1 ratio to start with either generic Sandoz travoprost or Travatan Z. Crossover happened after 3 weeks. The primary endpoint, intraocular pressure, was measured in both eyes at baseline, at week 3, and at week 6. The secondary endpoint was tolerability of both drugs as assessed by a questionnaire administered at week 3 and week 6.. The intraocular pressure lowering effect of generic Sandoz travoprost was equivalent to that of Travatan Z (18.20 ± 3.41 mmHg and 18.44 ± 3.48 mmHg respectively, p < 0.0001). Tolerability, as measured with a questionnaire, was similar between the two formulations of travoprost.. This study is the first to compare a brand-name travoprost with one of its generic forms and adds to the body of evidence that generic glaucoma eye drops are as effective and well-tolerated as their brand name counterparts. The intraocular pressure lowering effect of generic Sandoz travoprost is equivalent to that of Travatan Z. Patient tolerance of generic and brand-name travoprost is similar.

Topics: Aged; Antihypertensive Agents; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Tolerance; Drugs, Generic; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Travoprost; Treatment Outcome

To compare latanoprost/timolol (LT) versus travoprost/timolol (TT) fixed combinations for ocular hypertension (OHT) associated with uveitis.. Thirty-six patients (55 eyes) who were treated with LT (28 eyes) or TT (27 eyes) for OHT associated with uveitis were reviewed retrospectively. Intraocular pressure (IOP) and inflammation scores at the initiation of treatment and at the last visit during therapy were analyzed.. Although IOP was reduced significantly in both LT and TT groups, the reduction rate was significantly greater with TT group than with LT. The differences in the reduction of IOP between the groups remained significant when the cases were classified into inflammation-induced OHT and steroid-induced OHT. Inflammation score was not exacerbated by LT or TT treatment.. Both LT and TT are safe and effective for the treatment of OHT associated with uveitis and greater IOP reduction may be achieved by TT than by LT treatment.

Topics: Antihypertensive Agents; Drug Combinations; Female; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Retrospective Studies; Timolol; Tonometry, Ocular; Travoprost; Treatment Outcome; Uveitis

A 54-year-old Indian male with a diagnosis of ocular hypertension was started on a prostaglandin analog (PGA) in both eyes to lower intraocular pressure. Six years later, he developed progressively increasing bilateral limbal conjunctival hyperpigmentation. Travoprost was discontinued and replaced with brinzolamide and over the next year, the patient's conjunctival pigmentation improved significantly in both the eyes. This case report documents with slit-lamp photography the first case of conjunctival pigmentation associated with PGA use that has been shown to have reversal with discontinuation of the PGA. Because of the widespread use of PGAs, and the evolving nature of the conjunctival pigmentation, clinicians should be aware of this reversible condition when considering biopsy or removal of conjunctival melanocytic lesions.

Topics: Antihypertensive Agents; Carbonic Anhydrase Inhibitors; Conjunctival Diseases; Drug Substitution; Humans; Hyperpigmentation; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Sulfonamides; Thiazines; Tonometry, Ocular; Travoprost

Establishing the true therapeutic effect of eyedrops when initiating glaucoma therapy is important. Accurate prediction of the intraocular pressure (IOP)-lowering response in the fellow eye when using a monocular trial eliminates the need for additional office visits to confirm the therapeutic effect.. To investigate the validity of the monocular trial in patients commencing topical glaucoma treatment at different time points.. Prospective cohort study of untreated patients with open-angle glaucoma or ocular hypertension at a hospital-based glaucoma service among treatment-naive individuals. The study dates were October 1, 2008, to November 30, 2009.. Participants had 8 visits. After the recruitment visit, IOP was measured in both eyes by masked applanation tonometry at 8 am, 11 am, and 4 pm for 7 consecutive weeks. Treatment with travoprost, 0.004%, was commenced at week 3 in the trial eye and at week 4 in the fellow eye.. Three IOP outcomes were measured for the trial eye, including unadjusted IOP-lowering effect, adjusted IOP-lowering effect, and true therapeutic effect.. Of 30 topical glaucoma treatment-naive individuals (11 male and 19 female), 16 had ocular hypertension and 14 had primary open-angle glaucoma. Their mean (SD) age was 64.4 (12.6) years (age range, 42-88 years). The unadjusted IOP-lowering effect overestimated the true therapeutic effect by mean (SD) 2.5 (4.8), 3.1 (3.8), and 4.9 (4.4) mm Hg at 8 am, 11 am, and 4 pm, respectively, and the mean (SD) adjusted IOP-lowering effect was almost identical to the true therapeutic effect at each of the 3 time points (0.43 [3.87], 0.02 [2.82], and -0.40 [3.90]), respectively. The correlation between the unadjusted effect of treatment and the true therapeutic effect was 0.55 (95% CI, 0.23-0.76), and the effect when adjusted by the monocular trial was 0.72 (95% CI, 0.49-0.86). Fellow eye responses to treatment were correlated at all time points (r range, 0.78-0.86). Treatment did not demonstrate any effect on the diurnal pattern of IOP.. The monocular trial of therapy is effective in accurately predicting the response of an untreated eye to monotherapy with a prostaglandin analogue at all daytime time points measured. There is no requirement for patients to be seen at the same time of day after treatment has commenced. The effect in the first eye predicts both the likelihood and magnitude of an effect in the second eye at all time points during office hours and negates the requirement for an additional visit to check the therapeutic effect when commencing therapy in the second eye.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cohort Studies; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Tonometry, Ocular; Travoprost

To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost.. Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later.. A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8 - 12] s (p < 0.0001). No eye developed corneal staining; punctate keratitis was absent in 13 (29.5%) patients at baseline and in 31 (70.4%) after 6 months (p < 0.001). OSDI changed from 16 (10 - 30) to 9 (2 - 20).. No patient treated with PQ-Travoprost developed ocular surface disease after 6 months of monotherapy, whereas many patients reached a good IOP control with lower IOP values. Ocular surface status statistically improved when examined by TF-BUT and corneal staining.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cohort Studies; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

This study discussed about the influence of local application of glaucoma medications -- travoprost eye drops to patients' tear film function. We selected 24 patients, 45 eyes with primary open-angle glaucoma or intraocular hypertension. All of the patients topically used the travoprost eye drops for one time every night. After and before the pharmacy, we proceeded 1, 2, 3 mo lines symptom score and Schirmer's test (St), corneal fluorescein staining (FL), breakup time of tear film (BUT). Average value of symptom score and FL of all the patients before pharmacy were 1.32 ± 1. 55, 0.42 ± 0.68, and 1, 2, 3mo after pharmacy were respectively 2.68 ± 1.59, 0.96 ± 0.81; 4.97 ± 1.62, 1.46 ± 0.62; 6.21 ± 1.33, 1.88 ± 0.44. Symptom score and FL of 1, 2, 3 mo patients after pharmacy were all prominent higher than it before pharmacy (P=0.00), and it gradually increased. The average value of patients symptom BUT and St before pharmacy were (7.71 ± 0.87s), (8.32 ± 2.63mm /5min) and 1, 2, 3 mo after pharmacy were respectively (6.93 ± 1.17s), (7.69 ± 3. 33mm /5min); (5.48 ± 1.29s), (6.79 ± 2.94mm /5min); (4.33 ± 1.83s), (5.98 ± 3.11mm/5min). BUT and St value after pharmacy were prominent all lower than the level before pharmacy (P=0.00). And it gradually reduced. Short-term use of travoprost eye drops would aggravate the corneal irritation of patients, and decrease the tear film stability and tear secretion.

Topics: Administration, Ophthalmic; Adult; Aged; Cloprostenol; Cornea; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Lacrimal Apparatus; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Tears; Time Factors; Travoprost; Treatment Outcome; Young Adult

To investigate the frequency of prostaglandin-associated periorbitopathy among bimatoprost, latanoprost and travoprost users.. Retrospective observational case series.. The study group included 105 patients who were using one of the drugs in one eye for more than 1 month, and the other eye was used as a control.. The frequency of prostaglandin-associated periorbitopathy.. Special care was taken to detect five prostaglandin-associated periorbitopathy findings. Hertel exophthalmometry measurements and colour pictures of the periocular area were taken.. Statistically significant differences were found among the groups regarding the presence of all prostaglandin-associated periorbitopathy findings (P < 0.05). Periorbital fat loss was the most frequent and was observed in nearly all prostaglandin-associated periorbitopathy patients except those who were relatively young. The overall frequency of prostaglandin-associated periorbito pathy was 93.3% in the bimatoprost group, 41.4% in the latanoprost group and 70% in the travoprost group. The frequency of deepening of the upper lid sulcus was 80% in the bimatoprost group, 15.7% in the latanoprost group and 45% in the travoprost group. The frequency of milder changes (the presence of either only periorbital fat loss or dermatochalasis involution or the presence of both) was higher in the latanoprost group (62%) than in the travoprost (35.7%) and bimatoprost (7.1%) groups.. Prostaglandin-associated periorbitopathy is as common as other adverse effects when careful examinations are performed and is more frequent and more severe in bimatoprost users. The loss of the periorbital fat pad is the first sign to occur during the evolution of prostaglandin-associated periorbitopathy, especially in older patients.

Topics: Adolescent; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Orbital Diseases; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost; Young Adult

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 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

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

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 confirm the possible mechanism by which topical prostaglandin antiglaucoma drugs cause a deep superior sulcus.. Among patients who used bimatoprost (Lumigan), latanoprost (Xalatan), or travoprost (Travatan) and who developed a deep upper lid sulcus, 18 eyes of 11 patients (mean age, 58.2 ± 8.9 years) were studied. Seven patients were binocular users of one of the eye drops and four were monocular users. Preaponeurotic orbital fat was obtained, and the mean adipocyte density compared.. In the four monocular users, mean adipocyte density of treated eyes was 1758.21 ± 158.15 cells/mm(2), and that of untreated eyes was 1258.73 ± 127.54 cells/mm(2). This difference was statistically significant (P = 0.04), suggesting that the adipocytes were atrophied in the treated eyes. The mean adipocyte density of the bimatoprost group was 2073.35 ± 184.89 cells/mm(2), that of the travoprost group was 1623.46 ± 218.99 cells/mm(2), and that of the latanoprost group was 1468.20 ± 113.44 cells/mm(2). The densities of the bimatoprost and travoprost groups, but not of the latanoprost group (P = 0.75), were significantly different from that of the untreated group (P < 0.001).. Fat atrophy can be considered a mechanism of upper eyelid sulcus deepening in patients using topical prostaglandin analogs.

Topics: Adipocytes; Adipose Tissue; Amides; Antihypertensive Agents; Atrophy; Bimatoprost; Cell Count; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Latanoprost; Male; Middle Aged; Ocular Hypertension; Orbital Diseases; Prostaglandins F, Synthetic; Travoprost

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, in vitro, the cytotoxicity profile of a new formulation of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution preserved with polyquaternium-1 0.001% (travoprost/timolol PQ) instead of benzalkonium chloride (BAK) with (1) commercially available travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (travoprost/timolol BAK), (2) commercially available latanoprost 0.005%/timolol 0.5% fixed combination ophthalmic solution (latanoprost/timolol BAK), and (3) their associated BAK concentrations.. Compounds tested on Wong-Kilbourne-derived human conjunctival epithelial cells: (1) phosphate-buffered saline, (2) polyquaternium-1 0.001% (Polyquad(®), PQ), (3) travoprost/timolol PQ, (4) travoprost/timolol BAK with 0.015% BAK (DuoTrav(®)), (5) BAK 0.015%, (6) latanoprost/timolol BAK with 0.020% BAK (Xalacom(®)), and (7) BAK 0.020%. Toxicological assays were used to assess cell viability [neutral red (NR), Alamar blue (AB)], apoptosis (YO-PRO-1, Hoechst 33342), and oxidative stress (H(2)DCF-DA, hydroethidine). The apoptosis and oxidative stress assays were each reported according to cell viability as observed with NR and AB (totaling 10 analyses per treatment).. The NR and AB assays demonstrated that cells incubated with travoprost/timolol PQ had significantly better viability than cells incubated with latanoprost/timolol BAK, travoprost/timolol BAK, BAK 0.015%, and BAK 0.020% (P<0.0001 for all). As assessed with YO-PRO-1 and Hoechst 33342 relative to cell viability determined with NR or AB, travoprost/timolol PQ produced significantly less apoptosis than travoprost/timolol BAK and latanoprost/timolol BAK and their respective BAK concentrations alone (P<0.0001 for all). Also, travoprost/timolol BAK induced less apoptosis than latanoprost/timolol BAK (P<0.0001). As assessed with H(2)DCF-DA as a ratio to NR or AB, all of the compounds without BAK (phosphate-buffered saline, PQ 0.001%, and travoprost/timolol PQ) and travoprost/timolol BAK produced significantly less reactive oxygen species than latanoprost/timolol BAK (P<0.0001 for all). As assessed with hydroethidine as a ratio to NR or AB, travoprost/timolol PQ produced significantly fewer superoxide anions than latanoprost/timolol BAK (P<0.0001). In contrast, release of superoxide anions (hydroethidine method) after incubation with travoprost/timolol BAK was not significantly different from incubation with latanoprost/timolol BAK or travoprost/timolol PQ.. Travoprost/timolol PQ may be better for ocular surface health than either BAK preserved formulations of latanoprost/timolol or travoprost/timolol.

Topics: Apoptosis; Benzalkonium Compounds; Cell Line; Cell Survival; Chemistry, Pharmaceutical; Clone Cells; Cloprostenol; Conjunctiva; Drug Combinations; Epithelial Cells; Humans; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Oxidative Stress; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Superoxides; Sympatholytics; Timolol; Travoprost

The aim of this study was to use a validated acute rabbit model to test the toxicity of a novel formulation of fixed-combination travoprost 0.004%/timolol 0.5% ophthalmic solution, which contains the antimicrobial preservative polyquaternium-1 (PQ), compared with the commercial formulation of fixed combinations travoprost 0.004%/timolol 0.5% ophthalmic solution and latanoprost 0.005%/timolol 0.5% ophthalmic solution, which both contain the preservative benzalkonium chloride (BAK).. Adult male New Zealand albino rabbits (n=24) were randomly divided into four groups. Phosphate-buffered saline (PBS), travoprost/timolol PQ, travoprost/timolol BAK, or latanoprost/timolol BAK were instilled onto rabbit eyes one drop, 15 times at 5 minute intervals. The ocular surface reactions were investigated at hour 4 and day 1 using slit lamp examination; in-vivo confocal microscopy (IVCM) for cornea, limbus, and conjunctiva-associated lymphoid tissue (CALT); conjunctival impression cytology; and standard immunohistology in cryosections for detecting CD45+ infiltrating cells and MUC-5AC-labeled cells.. Travoprost/timolol PQ was better tolerated than travoprost/timolol BAK or latanoprost/timolol BAK. This improved tolerance was evident via clinical observation under slit lamp, IVCM in different layers of the cornea and conjunctiva, conjunctival impression cytology of superficial epithelium aspects, and immunohistochemistry for inflammatory infiltration of CD45+ cells in the cornea and goblet cell distribution. Travoprost/timolol PQ was similar to PBS in regards to in-vivo findings, the Draize test for ocular irritation, and epithelial and limbal aspects as evaluated with IVCM. Treatment with either travoprost/timolol PQ or PBS produced no obvious inflammatory infiltration inside and outside the CALT follicles, yielded similar IVCM toxicity scores and CD45+ cell counts, and eyes treated with either solution had normal goblet cells.. The fixed combination of travoprost/timolol with 0.001% PQ had decreased ocular surface toxicity relative to the BAK-containing solutions. The potential benefit to the human ocular surface with oncedaily dosing needs to be evaluated clinically.

Topics: Animals; Anti-Bacterial Agents; Antihypertensive Agents; Benzalkonium Compounds; Cell Survival; Cloprostenol; Conjunctiva; Disease Models, Animal; Drug Combinations; Epithelium, Corneal; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Rabbits; Timolol; Travoprost; Treatment Outcome

The purpose of this study is to examine the changes of the retina and the intrinsic survival signals of the retina by brinzolamide (Azopt®) and travoprost (Travatan®) in a rat model of chronic ocular hypertension.. Chronic ocular hypertension was induced by cauterization of three episcleral veins. Terminal deoxynucleotidyl transferase-mediated dUTP-nick end-labeling (TUNEL) staining was performed and the expression of glial fibrillary acidic protein (GFAP) was examined to evaluate changes of retinal ganglion cell (RGC) apoptosis and glial cell activation. Western blot analyses of the bcl-2 family and extracellular signal-regulated kinases (ERK) were done to identify changes of the intrinsic survival signaling pathway in the retina.. GFAP expression and TUNEL staining revealed significant decreases in RGC apoptosis and glial cell activation after brinzolamide and travoprost administration; bcl-2 and bcl-xL expression were significantly increased after intraocular pressure elevation and it was further increased with brinzolamide and travoprost treatment. This enhancement of survival signaling may have contributed to the decrease in RGC apoptosis. However, the role of ERK signaling was not significant.. Decrease in retinal damage and increased intrinsic survival signals suggests the neuroprotective potential of brinzolamide and travoprost in an animal model of chronic ocular hypertension, but further studies are required.

Topics: Administration, Topical; Animals; Antihypertensive Agents; bcl-X Protein; Blotting, Western; Carbonic Anhydrase Inhibitors; Cell Survival; Disease Models, Animal; Extracellular Signal-Regulated MAP Kinases; Glial Fibrillary Acidic Protein; In Situ Nick-End Labeling; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Proto-Oncogene Proteins c-bcl-2; Rats; Rats, Sprague-Dawley; Retina; Retinal Ganglion Cells; Signal Transduction; Sulfonamides; Thiazines; Travoprost

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

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

To compare the toxicological profile of a new formulation of travoprost 0.004% ophthalmic solution (travoprost PQ), containing the preservative polyquaternium-1(PQ, polyquad), with the commercially available formulation of benzalkonium chloride (BAK)-preserved travoprost 0.004% ophthalmic solution (travoprost BAK) and BAK-preserved latanoprost 0.005% ophthalmic solution (latanoprost BAK).. Human conjunctival epithelial cells were incubated with phosphate-buffered saline (PBS), BAK 0.015%, BAK 0.020%, PQ 0.001%, travoprost PQ preserved with PQ 0.001%, travoprost preserved with BAK 0.015%, or latanoprost preserved with BAK 0.020%. Six toxicological assays were used to assess: cell viability (neutral red, Alamar blue), apoptosis (YO-PRO-1, Hoechst 33342), and oxidative stress (H(2)DCF-DA, hydroethidine). Apoptosis and oxidative stress were each reported according to cell viability as observed with neutral red and Alamar blue for a total of 10 analyses per treatment depending on the cell viability test used to interpret apoptosis and oxidative stress responses.. There were no significant differences in toxicity between cells exposed to PBS and cells exposed to travoprost PQ (10/10 analyses) or PQ 0.001% (9/10 analyses). Ten out of 10 analyses revealed that travoprost PQ produced significantly less cytotoxicity than latanoprost BAK (p < 0.0001). Travoprost PQ produced significantly better cell viability and less apoptosis than travoprost BAK (6/6 analyses, p < 0.0001). Travoprost BAK was significantly less cytotoxic than latanoprost BAK in 7 of 10 analyses (p < 0.0001). All 10 of the analyses revealed that BAK 0.015%, BAK 0.020%, and latanoprost BAK produced significantly more cytotoxicity than PBS (p < 0.0001). Travoprost BAK was significantly less cytotoxic than its corresponding BAK 0.015% preservative solution in 9 of 10 analyses (p < 0.0001).. A panel of in vitro toxicity analyses supports the safety of travoprost PQ. Travoprost PQ may be better for ocular surface health than BAK-preserved formulations of latanoprost or travoprost but clinical studies are required to validate these comparisons.

Topics: Antihypertensive Agents; Apoptosis; Benzalkonium Compounds; Cell Survival; Cells, Cultured; Cloprostenol; Conjunctiva; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Epithelial Cells; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Oxidative Stress; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

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

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

This study aimed to compare the cost effectiveness of travoprost versus a fixed combination of latanoprost/timolol as first-line therapies for ocular hypertension or glaucoma.. Patient charts were extracted from the UK General Practitioner Research Database. Patients with ocular hypertension or glaucoma who received first-line treatment with either travoprost or latanoprost/timolol and were followed up for >6 months were included. Treatment failure was defined as a treatment change or a glaucoma intervention (laser therapy or surgery). Time to treatment failure was compared using a Cox model and adjusted by the propensity score method.. Eligible patients received either travoprost (n=639) or latanoprost/timolol (n=176). Their mean age was 70 years at diagnosis and 48.2% of patients were male. Patient characteristics did not differ significantly between treatment groups. Treatment failure rates at 1 year were 31.3% (travoprost) and 39.4% (latanoprost/timolol) and yielded a hazard ratio for failure in favour of travoprost (0.75; p<0.04) after adjusting for age, sex, co-morbidities and duration of follow-up. Adjusted annual costs of glaucoma management were significantly (p<0.001) less with travoprost (pound215.86) than with latanoprost/timolol (pound327.83).. In everyday practice, travoprost was maintained longer than latanoprost/timolol as first-line therapy for glaucoma. The mean daily costs of travoprost were 50.8% less per patient than those of latanoprost/timolol. Despite adjustments, these results might be confounded, at least partially, by disease severity.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cost-Benefit Analysis; Databases, Factual; Drug Combinations; Female; Glaucoma; Humans; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Physicians, Family; Prostaglandins F, Synthetic; Timolol; Travoprost; United Kingdom

To identify risk factors for poor adherence to topical once daily therapy for glaucoma.. Prospective, observational cohort study.. A total of 196 patients with glaucoma who were being treated with a prostaglandin analog in 1 or more eyes at the Scheie or Wilmer Eye Institutes between August 2006 and June 2007.. Demographics, ocular history, and responses to interview questions about glaucoma knowledge, health beliefs, and drop-taking behaviors were obtained from each patient. All patients used the Travatan Dosing Aid (DA; Alcon Laboratories Inc., Fort Worth, TX) to administer travoprost as prescribed. Devices were collected at 3 months, and the data of drop use were downloaded using software provided with the DA. Patients taking 75% of doses.. Risk factors for poor adherence.. Eighty-seven patients (44.4% of the 196 subjects with evaluable data at 3 months) used the DA on 75% or less of the monitored days. In univariate analysis, poorer adherers were more likely to be <50 or >or=80 years of age, to be African American, to report less than excellent health, to report higher amounts of depression, to have lower income, and to be treated at the Scheie Eye Institute. Multivariate analysis (adjusting for education and income) found that age, race/ethnicity, and less than excellent health were associated with poor adherence.. Those who failed to take more than 75% of eyedrop doses were more likely to be African American and to report poor health. Those in the youngest and oldest age groups were less adherent, although this finding was not always statistically significant. Further research into the factors driving these associations and into developing predictive models to assist in screening for low adherence are warranted.. Proprietary or commercial disclosure may be found after the references.

Topics: Age Factors; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Monitoring; Ethnicity; Female; Follow-Up Studies; Glaucoma; Health Knowledge, Attitudes, Practice; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Risk Factors; Surveys and Questionnaires; Travoprost

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

Experimental studies demonstrated an alteration of corneal collagen structure by prostaglandin analogues. The possible effect of the prostaglandin F(2alpha) analogue travoprost 0.004% on the central corneal thickness (CCT) in newly diagnosed glaucoma patients was evaluated.. Consecutive, interventional case series. Seventy-four patients/136 eyes with glaucoma were included in the statistical analysis. All patients received travoprost 0.004% (Travatan(R)) once daily in one or both eyes. CCT was measured by using noncontact optical low-coherence reflectometry prior to the treatment and after 6 and 12 months.. Mean CCT of all treated eyes (n = 136) was 546.71 +/- 34.63 mum at baseline, 535.14 +/- 34.78 mum after 6 months, and 532.38 +/- 34.18 mum after 12 months (ANOVA, P < 0.001). Ninety-five percent of all treated eyes showed a decrease of CCT. CCT reduction mainly developed within the first 6 months of the treatment period. After 12 months, a CCT reduction >30 mum occurred in 5.1% of all treated eyes. There was a significant correlation between the magnitude of corneal thinning and the initial CCT but not between corneal thinning and IOP reductions.. Topical therapy with the prostaglandin derivate travoprost is accompanied by a significant reduction of CCT within one year of treatment. Further clinical studies are needed to evaluate the possible long-term effects of prostaglandins on the CCT of glaucoma patients.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cornea; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Tomography, Optical Coherence; Tonometry, Ocular; Travoprost; Ultrasonography

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 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

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

This study compared the toxicity profiles of three antiglaucoma prostaglandin F2alpha analogs, latanoprost, travoprost, and bimatoprost which contain benzalkonium chloride (BAK), with tafluprost, a new preservative-free prostaglandin analog.. IOBA-NHC cells were exposed to BAK-containing prostanoid solutions, their respective BAK concentrations, and preservative-free tafluprost solution for 30 min. Membrane integrity, apoptosis, oxidative stress, and cells morphology were evaluated.. Preservative-free tafluprost resulted in significantly higher membrane integrity and lower pro-apoptotic and pro-oxidative effects than preservative-containing prostaglandin analog preparations.. These results suggest that tafluprost, a new preservative-free prostaglandin analog, has very low or no pro-apoptotic, pro-necrotic, or pro-oxidative effects in vitro compared to preservative-containing formulations.

Topics: Amides; Apoptosis; Benzalkonium Compounds; Bimatoprost; Cell Line; Cell Membrane; Cell Survival; Cloprostenol; Conjunctiva; Dinoprost; DNA; Drug Combinations; Epithelial Cells; Glaucoma; Humans; Latanoprost; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Prostaglandins F, Synthetic; Receptors, Purinergic P2; Receptors, Purinergic P2X7; Superoxides; 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

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: 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 determine monthly cost and cost effectiveness of bilateral prostaglandin/prostamide therapy for lowering intraocular pressure (IOP) in patients taking bimatoprost 0.03% (Lumigan, Allergan, Inc.), latanoprost 0.005% (Xalatan, Pfizer, Inc.), or travoprost 0.004% (Travatan, Alcon Laboratories, Inc.).. Drops in five new 2.5-mL bottles were counted and then averaged for each drug. Average retail price was determined by surveys of pharmacies. Drop count, average retail price, average wholesale price, and IOP reduction data were used to compute annual cost, and cost effectiveness (annual cost-per-mm Hg of IOP reduction) of the three drugs.. Drops per 2.5-mL bottle averaged 113 for bimatoprost 0.03%, 84 for latanoprost 0.005%, and 83 for travoprost 0.004%. Average retail cost (2005) per bottle was $69.99 for bimatoprost 0.03%, $61.69 for latanoprost 0.005%, and $66.37 for travoprost 0.004%. The monthly retail cost of bilateral therapy was $37.92 for bimatoprost 0.03%, $44.75 for latanoprost 0.005%, and $49.25 for travoprost 0.004%. Cost effectiveness ranges were $57 to $65 per mm Hg reduction in IOP per year for bimatoprost, 0.03%, $67 to $90 per mm Hg for latanoprost 0.005%, and $74 to $84 per mm Hg for travoprost 0.004%.. Bimatoprost 0.03% had the lowest monthly and annual costs and the greatest cost effectiveness for lowering IOP compared with latanoprost 0.005% and travoprost 0.004%.

Topics: Amides; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Economics, Pharmaceutical; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Travoprost

Cost-effectiveness evaluation of monotherapy with the newer lipid class of intraocular pressure (IOP)-lowering medications in glaucoma and ocular hypertension.. Retrospective pharmacoeconomic analysis.. Analysis included all published studies measuring IOP reduction from untreated baseline with once-daily bimatoprost (Lumigan), latanoprost (Xalatan), or travoprost (Travatan) monotherapy in patients with elevated IOP. Percentage IOP reduction at the final study visit was calculated using the early morning IOP measurement to control for diurnal variation in IOP. Patient-weighted average percentage IOP reductions were computed for each medication. Cost per 2.5-ml bottle was determined using PriceAlert 2005 (February). Cost-effectiveness was defined as monthly cost of medication per patient-weighted average 1% reduction in IOP.. Studies included 951 bimatoprost, 1598 latanoprost, and 765 travoprost patients. The AWP in February, 2005 for a 2.5-ml bottle was 62.10 dollars for bimatoprost, 61.29 dollars for latanoprost, and 62.19 dollars for travoprost. Patient-weighted average IOP reduction was 32.4% for bimatoprost, 29.6% for latanoprost, and 29.0% for travoprost. Calculated cost-effectiveness was 1.92 dollars for bimatoprost, 2.07 dollars for latanoprost, and 2.14 dollars for travoprost. Incremental cost-effectiveness ratio (ICER) analysis showed an incremental cost of 0.29 dollars for each additional 1% IOP reduction provided by bimatoprost over latanoprost. The rank order of the cost-effectiveness of the drugs (bimatoprost > latanoprost > travoprost) was robust in sensitivity analyses to cost and efficacy.. On the basis of AWP and patient-weighted average percentage IOP reduction in published studies, bimatoprost had the most favorable cost-effectiveness among the drugs compared. Cost-effectiveness should be considered along with traditional clinical safety and efficacy measures to make individual and group healthcare decisions.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

Topics: Adult; Antihypertensive Agents; Blood-Aqueous Barrier; Cloprostenol; Drug Synergism; Drug Therapy, Combination; Gonioscopy; Humans; Intraocular Pressure; Male; Ocular Hypertension; Timolol; Travoprost; Uveitis, Anterior

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

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

Topics: Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Patient Selection; Travoprost; Treatment Outcome

To determine the mechanism by which travoprost, a prodrug of a prostaglandin F2alpha analog, reduces intraocular pressure (IOP) in cynomolgus monkey eyes.. One eye each of 12 monkeys was treated with laser burns to the trabecular meshwork to elevate IOP. At least 4 months later (Baseline Day), IOP was measured by pneumatonometry (9:00 AM and 11:45 AM), and aqueous flow and outflow facility were determined by a fluorophotometric method. Uveoscleral outflow was calculated. Both eyes were treated with travoprost 0.004% at 9:00 AM and 5:00 PM for two days and at 9:30 AM on the third day (Treatment Day), when measurements were repeated as on Baseline Day. Statistical analyses were performed using two-tailed, paired t tests.. On Treatment Day compared with Baseline Day, IOP in hypertensive eyes was reduced at 2.25 hours (25.8 +/- 11.2 vs 33.7 +/- 13.2 mm Hg; mean +/- standard error of the mean [SEM]; P = 0.02) and 16 hours (26.3 +/- 10.2 vs 35.1 +/- 13.6 mm Hg; P = 0.02) after treatment. The increase in uveoscleral outflow was not significant. In normotensive eyes, IOP was reduced at 2.25 hours (19.0 +/- 3.7 vs 23.0 +/- 4.0 mm Hg; P = 0.03) and 16 hours (20.7 +/- 5.4 vs 23.4 +/- 5.3 mm Hg; P = 0.01) after treatment, and uveoscleral outflow was significantly (P = 0.02) increased (1.02 +/- 0.43 vs 0.35 +/- 0.72 microL/min).. Travoprost reduces IOP in normotensive monkey eyes by increasing uveoscleral outflow. The IOP reduction in hypertensive eyes is probably via the same mechanism, although the increased uveoscleral drainage did not reach statistical significance. Travoprost had no effect on aqueous flow or outflow facility.

Topics: Animals; Antihypertensive Agents; Aqueous Humor; Cloprostenol; Disease Models, Animal; Female; Fluorophotometry; Intraocular Pressure; Laser Coagulation; Macaca fascicularis; Ocular Hypertension; Prodrugs; Tonometry, Ocular; Trabecular Meshwork; Travoprost

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

Open-angle glaucoma affects an estimated 33 million individuals worldwide. An intraocular pressure >21 mm Hg in individuals with no evidence of optic nerve damage is termed ocular hypertension, a risk factor for glaucoma that has been estimated to affect as many as 10% of individuals 40 years of age or older.. The purpose of this research was to assess persistency (time on therapy) with prostaglandin analogues in the treatment of glaucoma or ocular hypertension.. This population-based, retrospective cohort study used the Protocare Sciences managed care database, which includes prescription and medical claims data from multiple managed care organizations. Patients 20 years of age or older who initiated therapy with latanoprost, bimatoprost, or travoprost (index drugs) between April 2001 and June 2002 were included. Patients were required to be continuously enrolled in the same plan for the 180 days preceding index prescription fill. Follow-up continued through June 30, 2002. Two outcome measures were analyzed: (1) discontinuation of the index prostaglandin and (2) either discontinuation or change in the index prostaglandin regimen. Changing therapy was defined as switching to or adding another ocular hypotensive agent. Cox regression models were used to compare rate ratios of discontinuation and discontinuation/change. Patient data were censored on termination of insurance coverage or at the end of the study period.. Overall, 7527 patients were prescribed a prostaglandin analogue; 4356 patients met the inclusion criteria (n = 2376, 993, and 987 for latanoprost, bimatoprost, and travoprost, respectively). A total of 58% of patients were women, and 74% were 65 years of age or older. Compared with latanoprost, those treated with bimatoprost were 38% more likely to discontinue and 31% more likely to discontinue/change therapy, and patients treated with travoprost were 36% more likely to discontinue and 29% more likely to discontinue/change therapy (P < 0.001 for each comparison).. Latanoprost-treated patients demonstrated significantly (P < 0.001) greater persistency than did those treated with either bimatoprost or travoprost.

Topics: Administration, Topical; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cohort Studies; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Patient Compliance; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Self Administration; Travoprost

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

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

The U.S. Food and Drug Administration approved more than 100 drugs and devices in 2001. This article discusses several of the new approvals, including ophthalmic drugs, contraceptive therapies, mental health medications, and medical devices.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Contraception; Device Approval; Diabetes Mellitus; Drug Approval; Humans; Insulin; Insulin Glargine; Insulin, Long-Acting; Intraocular Pressure; Lipids; Macular Degeneration; Ocular Hypertension; Pacemaker, Artificial; Porphyrins; Travoprost; United States; United States Food and Drug Administration; Verteporfin

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

Travoprost is the isopropyl ester prodrug of a high affinity, selective FP prostaglandin full receptor agonist. In contrast to travoprost acid's high affinity and efficacy at the FP receptor, there is only sub-micromolar affinity for the DP, EP1, EP3, EP4, IP, and TP receptors. Travoprost produced a lower incidence of ocular irritation than PGF20 isopropyl ester at a dose of 1 microg in the New Zealand albino (NZA) rabbit. Topical ocular application of travoprost produced a marked miotic effect in cats following doses of 0.01, 0.03 and 0.1 microg. In the ocular hypertensive monkey, b.i.d. application of 0.1 and 0.3 microg of travoprost afforded peak reduction in intraocular pressure (IOP) of 22.7% and 28.6%, respectively. Topical application of travoprost was well tolerated in rabbits, cats and monkeys, causing no ocular irritation or discomfort at doses up to 1 microg. Travoprost is a promising ocular hypotensive prostaglandin FP derivative that has the ocular hypotensive efficacy of PGF2alpha isopropyl ester but with less severe ocular side effects.

Topics: Adenylyl Cyclases; Administration, Topical; Animals; Antihypertensive Agents; Cats; Cattle; Cloprostenol; Corpus Luteum; Dinoprost; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; Female; Fibroblasts; Humans; Intraocular Pressure; Macaca; Mice; Ocular Hypertension; Ophthalmic Solutions; Phosphatidylinositols; Rabbits; Receptors, Prostaglandin; Trabecular Meshwork; Travoprost