bimatoprost and Ocular-Hypertension

Sustained release drug delivery has the potential to change glaucoma care by decreasing the challenge of medication adherence. Many approaches are in development, but this review focuses on Durysta (Allergan plc, Dublin, Ireland), the only FDA-approved sustained release intracameral treatment available at this time.. Durysta is a bimatoprost sustained release (BimSR) intracameral implant. Clinical trials have demonstrated that BimSR implants can provide comparable levels of intraocular pressure (IOP) control as topical eyedrops. BimSR has advantages such as decreasing concerns regarding drop adherence, reducing ocular surface and periocular side effects from topical drops, and decreased daily treatment burden for patients. In addition, studies have shown continued IOP lowering in some eyes during extended follow-up periods when all of the BimSR medication has already been delivered. Hypothesized mechanisms to explain this finding include increased matrix metalloproteinase expression that causes extracellular matrix reorganization to permit greater aqueous outflow, as well as decreased episcleral venous pressure. The major safety concern at this time for Durysta and future intracameral implants is corneal endothelial cell loss, which was worse with repeat BimSR administration compared to single dosing. Several studies are underway to investigate mechanisms of action and to better understand safe and effective dosing of medications in this class.

Topics: Antihypertensive Agents; Bimatoprost; Delayed-Action Preparations; Humans; Injections, Intraocular; Intraocular Pressure; 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

Bimatoprost implant (Durysta™), developed by Allergan, is a sustained-release drug delivery system containing bimatoprost, a prostaglandin analogue with ocular hypotensive activity. The implant, administered intracamerally, involves the use of a biodegradable, solid polymer drug delivery system for slow, sustained drug release, designed to lower intraocular pressure (IOP) over a 4- to 6-months period. In March 2020, bimatoprost implant received its first approval, in the USA, for use to reduce IOP in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). Allergan's clinical development programme for bimatoprost implant is ongoing. This article summarizes the milestones in the development of bimatoprost implant leading to this first approval for use in the reduction of IOP in patients with OAG or OHT.

Topics: Bimatoprost; Drug Approval; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Prostheses and Implants

Of the side effects of prostaglandin analogues (PGAs), uveitis and cystoid macular oedema (CME) have significant potential for vision loss based on postmarket reports. Caution has been advised due to concerns of macular oedema and uveitis. In this report, we researched and summarised the original data suggesting these effects and determined their incidence.. Preferred Reporting Items for Systematic review and Meta-Analyses guidelines were followed. Studies evaluating topical PGAs in patients with ocular hypertension or open angle glaucoma were included. MEDLINE, PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library, LILACS and ClinicalTrials.gov were searched between 1946 and 2019. Experimental studies, animal studies and randomised studies with other intraocular pressure-lowering eye drops were excluded.. 214 studies (28 232 patients) met the inclusion criteria. Using prospective data, the incidence of uveitis and CME among PGA users were 62/28 232 (0.22%) and 25/28 232 (0.09%), respectively. A higher frequency of both uveitis and CME were found among latanoprost users compared with bimatoprost. There were 21 case studies reporting CME including 48 eyes in 43 patients. 47 of 48 eyes (97.9%) had previous incisional ocular surgery. 8 eyes were re-challenged, of which 7 (87.5%) recurred. 7 case studies reported uveitis in 15 eyes of 10 patients. 7 of 15 eyes (46.7%) were either pseudophakic or aphakic. 6 eyes were re-challenged, and all 6 (100%) recurred.. Cases of uveitis or CME revealed a confounding effect of ocular surgery, aphakia or subluxed intraocular lens. PGAs may be used in non-surgical patients without concern of causing CME or uveitis. The incidences of PGA-associated CME and uveitis are rare with limited prospective studies on the cause-effect relationship.

Topics: Administration, Ophthalmic; Bimatoprost; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Macular Edema; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins, Synthetic; Uveitis

There is a limit beyond which increasing either the concentration of a prostaglandin analog (PGA) or its dosing frequency fails to produce increases in ocular hypotensive efficacy with topical dosing. Intracameral PGA dosing with a bimatoprost implant, however, does not exhibit the same intraocular pressure (IOP)-lowering plateau at studied concentrations, and the maximum-achievable ocular hypotensive effects are not yet known. This suggests that the bimatoprost intracameral implant may activate another mechanism of action in addition to the mechanism(s) activated by topical application. Episcleral venous pressure (EVP) is a key determinant of IOP, and experimental manipulation of the episcleral vasculature can change both EVP and IOP. The recent observation that topical and intracameral PGA drug delivery routes produce different patterns of conjunctival hyperemia suggested that the differences in the IOP-lowering profiles may be caused by differing effects on the episcleral vasculature. Recent experiments in animals have shown that topical PGAs increase EVP, while the bimatoprost intracameral implant causes a smaller, transient increase in EVP, followed by a sustained decrease. The increase in EVP could be limiting the IOP-lowering efficacy of topical PGAs. In contrast, the decrease in EVP associated with the bimatoprost implant could explain its enhanced IOP-lowering effects. Further research on EVP as a target for IOP lowering is indicated to improve our understanding of this potentially important pathway for treating patients with glaucoma.

Topics: Administration, Ophthalmic; Animals; Antihypertensive Agents; Bimatoprost; Drug Implants; Glaucoma; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins, Synthetic; Sclera; Venous Pressure

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

Glaucoma is a common eye disease that can lead to irreversible vision loss if left untreated. The early diagnosis and treatment of primary open-angle glaucoma is challenging, and visual impairment in Chinese glaucoma patients is a serious concern. Most of these patients need more than one topical antiglaucoma agent to control their intraocular pressures (IOPs). In the People's Republic of China, the daily cost of different glaucoma medication varies greatly, and the treatment habits differ throughout the country. Prostaglandin analogs (PGAs) are recommended as first-line monotherapy, because of their efficacy and low risk of systemic side effects. Fixed-combination drops, particularly PGA-based fixed combinations, have recently been developed and used in patients with progression or who have failed to achieve their target IOPs. Here, we reviewed the current literature on the use of bimatoprost-timolol fixed combination (BTFC) in the People's Republic of China. BTFC has achieved good efficacy and tolerability in Chinese clinical trials. In addition, BTFC is more cost effective compared with other fixed combinations available in the People's Republic of China. Fixed-combination drops may offer benefits, such as keeping the ocular surface healthy, convenience of administration, and improvement in long-term adherence and quality of life. Therefore, BTFC has great potential for the treatment of Chinese glaucoma patients. However, the long-term efficacy of BTFC, comparisons of BTFC with other fixed-combination drugs, and treatment adherence and persistence with treatment in Chinese patients are unknown and will require further study.

Topics: Adrenergic beta-Antagonists; Asian People; Bimatoprost; China; Drug Combinations; Glaucoma; Humans; Ocular Hypertension; Timolol

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

Topically administered bimatoprost 0.03%/timolol 0.5% ophthalmic solution (bimatoprost/timolol: Ganfort) comprises the synthetic prostamide bimatoprost (structurally related to prostaglandin F2 alpha) and the beta-adrenergic receptor antagonist timolol. Bimatoprost/timolol (one drop administered in the affected eye[s] once daily in the morning or evening) is an effective and well tolerated fixed combination for lowering intra-ocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (OHT), including individuals uncontrolled on monotherapy with a beta-adrenergic receptor antagonist or prostaglandin analogue/prostamide.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Cost-Benefit Analysis; Drug Combinations; Glaucoma; Humans; Latanoprost; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol

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

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

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

When a single medication does not adequately control intraocular pressure, additional intraocular hypotensive agents are often added to the therapeutic regime. However, regimen complexity has been associated with reduced patient compliance. Treatment with a fixed combination may, therefore, increase compliance as a result of simplifying the dosage regimen. Bimatoprost/timolol fixed combination (BTFC) combines two clinically effective agents that decrease elevated intraocular pressure by independent mechanisms. In two clinical studies, BTFC was more effective than its individual components. Furthermore, in a non-inferiority study BTFC has been shown to be as effective as the association of its individual components. BTFC was clinically effective and generally well tolerated, with no unexpected adverse reactions reported for the BTFC compared with those reported for bimatoprost or timolol monotherapies.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Blood Pressure; Cloprostenol; Drug Combinations; Glaucoma; Humans; Lipids; Ocular Hypertension; Timolol; Treatment Outcome

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

This meta-analysis was performed to evaluate the efficacy and tolerability of bimatoprost compared with latanoprost in reducing intraocular pressure (IOP).. Pertinent studies were identified through searches of PubMed, EMBASE, the Chinese Biomedicine Database, and the Cochrane Controlled Trials Register up to February 1, 2008, using the terms bimatoprost, Lumigan, latanoprost, and Xalatan. Searches of meeting abstracts and the manufacturers' databases were also performed. Randomized controlled trials comparing bimatoprost with latanoprost in patients with elevated IOP were selected. The main efficacy measures were the weighted mean difference (WMD) in the percentage of IOP reduction (IOPR%) and the rate difference (RD) in the percentage of patients with a target IOP of

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Treatment Outcome

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

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

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

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

Bimatoprost (Lumigan), Allergan) is a highly efficacious ocular hypotensive agent that provides good diurnal control of intraocular pressure in glaucoma and ocular hypertensive patients. Bimatoprost is a synthetic molecule that is structurally and pharmacologically similar to prostamide F(2), and appears to mimic the activity of the prostamides. Consistent with prostamide-mimetic activity, bimatoprost has potent inherent pharmacological activity in prostamide-sensitive preparations and essentially remains intact in the living primate eye. This is sufficient to explain its potent and efficacious ocular hypotensive activity, and suggests that bimatoprost is a pharmacologically unique compound.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Humans; Intraocular Pressure; Lipids; Ocular Hypertension

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

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

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

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

Bimatoprost (Lumigan) is a pharmacologically unique and highly efficacious ocular hypotensive agent. It appears to mimic the activity of a newly discovered family of fatty acid amides, termed prostamides. One biosynthetic route to the prostamides involves anandamide as the precursor. Bimatoprost pharmacology has been extensively characterized by binding and functional studies at more than 100 drug targets, which comprise a diverse variety of receptors, ion channels, and transporters. Bimatoprost exhibited no meaningful activity at receptors known to include antiglaucoma drug targets as follows: adenosine (A(1-3)), adrenergic (alpha(1), alpha(2), beta(1), beta(2)), cannabinoid (CB(1), CB(2)), dopamine (D(1-5)), muscarinic (M(1-5)), prostanoid (DP, EP(1-4), FP, IP, TP), and serotonin (5HT(1-7)). Bimatoprost does, however, exhibit potent inherent pharmacological activity in the feline iris sphincter preparation, which is prostamide-sensitive. Bimatoprost also resembles the prostamides in that it is a potent and highly efficacious ocular hypotensive agent. A single dose of bimatoprost markedly reduces intraocular pressure in dogs and laser-induced ocular hypertensive monkeys. Decreases in intraocular pressure are well maintained for at least 24 hr post-dose. Human studies have demonstrated that systemic exposure to bimatoprost is low and that accumulation does not occur. The sclera is the preferred route of accession to the eye. The high scleral permeability coefficient Papp is a likely contributing factor to the rapid onset and long-acting ocular hypotensive profile of bimatoprost.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Intraocular Pressure; Iris; Lipids; Muscle, Smooth; Ocular Hypertension

Bimatoprost is a new ocular hypotensive agent that lowers intraocular pressure (IOP) in normal, ocular hypertensive, and glaucomatous eyes. Its mechanism of action has been studied in normal human subjects. Bimatoprost mildly stimulates the rate of aqueous humor flow during the day (13%) and at night (14%). Its ocular hypotensive action is due primarily to a 26% reduction in the tonographic resistance to outflow. Thus, bimatoprost enhances the pressure-sensitive outflow pathway. Additional beneficial effects may include an increase in the rate of flow via the pressure-insensitive outflow pathway (sometimes called the "uveoscleral outflow pathway") and a lowering of the extraocular recipient pressure (sometimes called "episcleral venous pressure"). Reduction of tonographic resistance to aqueous humor outflow reduces steady-state IOP, an effect that is beneficial for the treatment of glaucoma. In addition to its effect on steady-state IOP, reduction of resistance allows the eye to recover more quickly from transient IOP elevations. The former effect is common to all ocular hypotensive drugs, but the latter effect is an exclusive property of drugs that reduce outflow resistance, such as bimatoprost.

Topics: Amides; Animals; Anterior Chamber; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension

We investigate the efficacy of triple-fixed-combination of bimatoprost/brimonidine/timolol once and twice a day, demonstrating higher intraocular pressure reduction with once-a-day use, and discuss possible implications based on previous literature.. The purpose of this study was to compare the efficacy of a fixed combination bimatoprost-timolol-brimonidine (Triplenex) instilled once-daily with twice-daily in primary open angle glaucoma.. A randomized clinical trial at a public eye care institution. Thirty patients with primary open angle glaucoma were followed up for 3 months. The right and left eyes of these patients were randomly assigned to once-daily (10:00  pm ) or twice-daily (10:00  am ; 10:00  pm ) regimens of fixed combination bimatoprost-timolol-brimonidine. Intraocular pressure peaks were obtained with the water drinking test before the introduction of this medication (basal WDT0), 1 month (WDT1), 2 months (WDT2), and 3 months (WDT3) after starting the use of the fixed combination of bimatoprost/timolol/brimonidine (Triplenex). Variation from peak intraocular pressure at WDT3 to peak at WDT0 was compared within groups of 2 versus once-daily regimen.. Sixty eyes of 30 patients (age: 70.67±9.70 y) were included in this study. Baseline clinical characteristics were comparable between groups. The mean reduction in peak intraocular pressure from WDT0 to WDT3 was 6.1±6.1 mm Hg (30.5%) in the eyes receiving 1 drop per day and 4.3±5.7 mm Hg (21.5%) in the eyes receiving 2 drops per day ( P =0.023). Mean reduction in peak intraocular pressure considering all WDT was also higher in the group with once-a-day treatment (5.90±6.03 vs. 4.46±4.28 mm Hg, P =0.006).. Fixed combination of bimatoprost 0.01%, brimonidine tartrate 0.15%, and timolol maleate 0.5% once-a-day is more effective in reducing peak intraocular pressure as measured by the WDT than twice-a-day dosing.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Double-Blind Method; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Timolol; Water

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).. This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).. Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2-7.4, 6.5-7.8, and 6.1-6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group.. The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. CLINICALTRIALS.. NCT02250651.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Dose-Response Relationship, Drug; Double-Blind Method; Drug Implants; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Timolol; Young Adult

The most common treatment for Primary Open-Angle Glaucoma (POAG) is the daily use of eye drops. Sustained-release drug delivery systems have been developed to improve patient adherence by achieving prolonged therapeutic drug concentrations in ocular target tissues while limiting systemic exposure. The purpose of this study is to compare the efficacy and safety of bimatoprost inserts with bimatoprost eye drops in patients with POAG and Ocular Hypertension (OH).. We include OH and POAG patients aged between 40 and 75 years-old. Both OH and POAG patients had intraocular pressure (IOP) greater than 21 and ≤30 mmHg at 9:00 am without glaucoma medication and normal biomicroscopy. Five normal patients with IOP≤14 mmHg constitute the control group. A chitosan-based insert of bimatoprost was placed at the upper conjunctival fornix of the right eye. In the left eye, patients used one drop of LumiganTM daily at 10:00 pm. For statistical analysis, a two-way analysis of variance (ANOVA), Student t-test, and paired t-test is used.. Sixteen POAG and 13 OH patients with a mean age of 61 years were assessed. In both eyes, IOP reduction was similar during three weeks of follow-up (19.5±2.2 mmHg and 16.9±3.1 mmHg), insert, and eye drop, respectively; P=0.165). The percentage of IOP reduction in the third week was 30% for insert and 35% for eye drops (P=0.165). No intolerance or discomfort with the insert was reported. Among the research participants, 58% preferred the use of the insert while 25% preferred eye drops, and 17% reported no preference.. Bimatoprost-loaded inserts showed similar efficacy to daily bimatoprost eye drops during three weeks of follow up, without major side effects. This might suggest a possible change in the daily therapeutic regimen for the treatment of POAG and OH.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Middle Aged; Ocular Hypertension; Ophthalmic Solutions

Many patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients who require multiple medications, but the number of fixed combinations combining 3 complementary IOP-lowering agents remains limited. This study assessed the efficacy and safety of a triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), compared with a dual fixed combination (DFC) of brimonidine 0.2%/timolol 0.5%.. Patients with a baseline IOP of 23-34 mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study. After washout of previous treatment (if applicable), patients were randomized to receive TFC or DFC twice daily in each eye for 3 months. The primary efficacy variable was the change from baseline in mean IOP in the worse eye at week 12 in the modified intent-to-treat (mITT) population. TFC was superior to DFC if the treatment difference (TFC - DFC) favored TFC at week 12 (P ≤ 0.05; 2-sample t test). Secondary and sensitivity analyses were also performed. Safety, including adverse events, was assessed at all visits.. The mITT/safety population included 185 patients (TFC, n = 90; DFC, n = 95). TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22). While treatment-related conjunctival hyperemia was more frequent with TFC than with DFC (47.8% vs 23.2%; P < 0.001), consistent with the additional presence of bimatoprost in TFC, most cases were mild and the numbers of patient discontinuations at week 12 were similar between the TFC and DFC groups (11 [12.2%] vs 7 [7.4%] patients; P = 0.266). No unexpected adverse events were reported.. Compared with DFC, TFC provided superior IOP lowering throughout the primary efficacy period. An acceptable tolerability profile was observed through 12 months of use of TFC, offering an effective therapeutic option in patients with POAG or OHT who require multiple medications to control their IOP. Additional studies are required for the assessment of the long-term effects of TFC. ClinicalTrials.gov identifier: NCT01217606.

Topics: Aged; Antihypertensive Agents; Bimatoprost; Brazil; Brimonidine Tartrate; Double-Blind Method; Drug Combinations; Female; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Timolol

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations.. Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study.. Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye, and study eye baseline IOP (hour 0; 8 am) of 22-32 mmHg after washout.. Study eyes received bimatoprost implant 10 μg (n = 198) or 15 μg (n = 198) on day 1 with readministration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n = 198). Intraocular pressure was measured at hours 0 and 2 at each visit.. Primary end points were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).. Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5-17.2, 16.5-17.0, and 17.1-17.5 mmHg through week 12 in the 10-μg implant, 15-μg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol and highest with the 15-μg dose strength. Incidence of corneal TEAEs increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-μg implant) and 21.8% (15-μg implant). Mean best-corrected visual acuity (BCVA) was stable; 3 implant-treated subjects with corneal TEAEs had >2-line BCVA loss at their last visit.. Both dose strengths of bimatoprost implant met the primary end point of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-μg implant over the 15-μg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Double-Blind Method; Drug Implants; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Timolol; Tonometry, Ocular; Vitreous Body; Young Adult

Bimatoprost-timolol (bimatoprost 0.03%-timolol 0.5% fixed-dose combination [FDC]) and tafluprost-timolol (tafluprost 0.0015%-timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost-timolol to PF tafluprost-timolol eye drops.. This was a 12-week, open-label, phase IV study.. Sixteen centres in Finland, Germany, Italy and the UK.. Patients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost-timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom.. Patients were switched to PF tafluprost-timolol once daily in the treated eye(s).. The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12.. Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost-timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost-timolol significantly reduced from screening to week 12 in all patients (p<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment.. Switching from BAK-preserved or PF bimatoprost-timolol to tafluprost-timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP.. EudraCT2014-005273-37; Results.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Drug Administration Schedule; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intention to Treat Analysis; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F; Quality of Life; Timolol

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

Topics: Aged; Antihypertensive Agents; Bimatoprost; Delayed-Action Preparations; Double-Blind Method; Drug Implants; Female; Glaucoma; Humans; Male; Middle Aged; Ocular Hypertension

The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF).. A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment.. Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs).. This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

Topics: Antihypertensive Agents; Bimatoprost; Cross-Over Studies; Double-Blind Method; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Slit Lamp; Tonometry, Ocular; Treatment Outcome; Visual Acuity

To compare the effect of bimatoprost and the fixed combination latanoprost-timolol (LTFC) on 24-hour systolic (SBP) and diastolic (DBP) blood pressure and on 24-hour ocular perfusion pressure (OPP).. 200 patients with glaucoma or ocular hypertension, controlled on the unfixed combination of latanoprost and timolol or eligible for dual therapy being not being fully controlled on monotherapy were enrolled in a randomized, double-masked, placebo-controlled, multicentre clinical trial. They were randomized to LTFC (8 a.m.) or bimatoprost (8 p.m.) and received 24-hour IOP curve at baseline, 6 and 12 weeks (supine and sitting position IOPs were recorded at 8 p.m., midnight, 5 a.m., 8a.m., noon and 4 p.m.). Holter 24-hour blood pressure curve was obtained between weeks 2 and 12. SBP, DBP, OPP were calculated and compared with ANOVA. Rates of diastolic OPP (DPP)≤50, ≤40, ≤30 mmHg in the 2 groups were calculated and compared using Fisher's test.. Mean baseline SBP and DBP were 136.5±18.3 vs 134.2±20.1 mmHg (p=0.1) and 79.1±10.2 vs 78.2±10.1 mmHg (p=0.4) in the bimatoprost and LTFC groups respectively. Holter SBP was significantly higher for bimatoprost (135.1 mmHg vs 128.1 mmHg, p=0.04), while no statistically significant difference in DBP was found. DPP was similar in the 2 groups, and proportions of patients with at least one value of the 24-hour curve≤50, ≤40, ≤30 mmHg were 94%, 86%, 41% respectively.. Bimatoprost and LTFC had similar DBPs and OPPs; SBP was significantly lower with LTFC. In this study, the percentage of "dippers" was considerably higher than the one described in previous studies on the role of perfusion pressure in glaucoma.. NCT02154217, May 21, 2014.

Topics: Adult; Aged; Amides; Analysis of Variance; Antihypertensive Agents; Bimatoprost; Blood Pressure; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol

To compare the 24-hour (24h) effects on intraocular pressure (IOP) and cardiovascular parameters of timolol 0.5% and bimatoprost 0.01% in open angle glaucoma and ocular hypertensive subjects.. In this prospective, randomized, double masked, crossover, clinical trial, after washout from previous medications enrolled subjects underwent 24h IOP, blood pressure (BP) and heart rate (HR) measurements and were randomized to either topical bimatoprost 0.01% at night plus placebo in the morning or to timolol 0.5% bid. After 8 weeks of treatment a second 24h assessment of IOP, BP and HR was performed and then subjects switched to the opposite treatment for additional 8 weeks when a third 24h assessment was performed. The primary endpoint was the comparison of the mean 24h IOP after each treatment. Secondary endpoints included the comparisons of IOP at each timepoint of the 24h curve and the comparison of BP, HR, ocular perfusion pressure and tolerability.. Mean untreated 24h IOP was 20.3 mmHg (95%CI 19.0 to 21.6). Mean 24h IOP was significantly lower after 8 weeks of treatment with bimatoprost 0.01% than after 8 weeks of treatment with timolol 0.5% bid (15.7 vs 16.8 mmHg, p = 0.0003). Mean IOP during the day hours was significantly reduced from baseline by both drugs while mean IOP during the night hours was reduced by -2.3 mmHg (p = 0.0002) by bimatoprost 0.01% plus placebo and by -1.1 mmHg by timolol 0.5% bid (p = 0.06). Timolol 0.5% significantly reduced the mean 24h systolic BP from baseline, the diastolic BP during the day hours, the HR during the night hours, and the mean 24h systolic ocular perfusion pressure.. Both Bimatoprost 0.01% and Timolol 0.5% are effective in reducing the mean 24h IOP from an untreated baseline but Bimatoprost 0.01% is more effective than timolol 0.5% throughout the 24h. Timolol 0.5% effect on IOP is reduced during the night hours and is associated with reduced BP, HR and ocular perfusion pressure.. EU Clinical Trial Register and EudraCT# 2010-024272-26.

Topics: Administration, Topical; Aged; Antihypertensive Agents; Bimatoprost; Blood Pressure; Circadian Rhythm; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Timolol; Tonometry, Ocular; Treatment Outcome

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

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

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

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

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

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

The aim was to compare efficacy and cost-effectiveness of bimatoprost 0.03% and brimonidine 0.2% in primary open-angle glaucoma (POAG)/ocular hypertension (OHT).. Open, randomized, cross-over, comparative study.. Forty patients of POAG or OHT with intraocular pressure (IOP) <30 mm Hg were included in the study after a written informed consent. The patients were divided randomly into two groups of 20 patients each. Patients of group A were administered bimatoprost 0.03% eye drops once daily, and those of group B brimonidine 0.2% eye drops twice daily for a period of 4 weeks. After a washout period of 4 weeks, the patients were crossed over that is, group A was administered brimonidine 0.2% and group B bimatoprost 0.03%. Fall in IOP at 4 weeks was recorded. The daily cost of each drug was calculated by maximum retail price and the average number of drops per bottle. The cost-effectiveness was then calculated as the cost of drug/mm Hg fall in IOP.. Independent samples t-test was used to compare the efficacy of both drugs.. IOP lowering with bimatoprost (8.9 ± 1.598 mm Hg) was significantly (P < 0.0001) higher than brimonidine (6.55 ± 1.26 mm Hg). The number of drops/ml were 33.43 ± 0.52 and 25.49 ± 0.26, respectively, for bimatoprost and brimonidine. Treatment with bimatoprost was costlier than brimonidine with daily costs/eye Rs. 4.02 ± 0.06 and 3.14 ± 0.03, yearly costs/eye Rs. 1467.46 ± 20.74 and 1147.75 ± 11.15, respectively. Bimatoprost was more cost-effective than brimonidine with the cost-effectiveness ratio (CER) respectively Rs. 13.10 ± 2.61/mm Hg and Rs. 13.96 ± 2.86/mm Hg. Incremental CER Rs. 10.43/mm Hg implies lower costs/mm Hg extra IOP lowering by bimatoprost than Rs. 13.96 for brimonidine.. In spite of being costlier, bimatoprost is more efficacious and cost-effective than brimonidine.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Cost-Benefit Analysis; Cross-Over Studies; Dose-Response Relationship, Drug; Economics, Pharmaceutical; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions

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 24-h intraocular pressure (IOP) control obtained with the bimatoprost-timolol fixed combination (BTFC) versus latanoprost in newly diagnosed, previously untreated exfoliation syndrome (XFS) or exfoliative glaucoma (XFG) patients with baseline morning IOP greater than 29 mm Hg.. One eye of 41 XFS/XFG patients who met inclusion criteria was included in this prospective, observer-masked, crossover, comparison protocol. All subjects underwent a 24-h untreated curve and were then randomised to either evening administered BTFC or latanoprost for 3 months and then switched to the opposite therapy. At the end of each treatment period, patients underwent a treated 24-h IOP assessment.. 37 patients completed the trial. At baseline, mean untreated 24-h IOP was 31.1 mm Hg. Mean 24-h IOP with BTFC was significantly lower than with latanoprost (18.9 vs 21.2 mm Hg; p<0.001). Furthermore, BTFC reduced IOP significantly more than latanoprost at every time point, for the mean peak and trough 24-h IOP (p<0.001). There was no difference, however, in mean 24-h IOP fluctuation between the two medications (3.8 with BTFC vs 4.2 with latanoprost; p=0.161). Both treatments were well tolerated and there was no statistically significant difference for any adverse event between them.. As first choice therapy in high-pressure, at-risk exfoliation patients, BTFC controlled mean 24-h IOP significantly better than latanoprost monotherapy.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Combinations; Exfoliation Syndrome; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Treatment Outcome; Visual Field Tests; Visual Fields

To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension.. In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12.. 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated.. Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

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

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 evaluate the long-term IOP-lowering effect of an initially successful switch from prostaglandine-analog (PGA) monotherapy to bimatoprosttimolol fixed combination (BTFC) METHODS: Prospective, monocentric, open-labeled clinical trial. 30 patients with insufficient intraocular pressure (lOP) control under PGA monotherapy were screened. Following a one month run-in period of BTFC, patients who presented an effective IOP-lowering response were prospectively studied for an additional 11-month period. IOP, tolerability and safety (adverse reactions, slit lamp biomicroscopy) were further assessed at month 6 and month 12 after initiating BTFC.. BTFC therapy significantly decreased IOP when compared to PGA monotherapy (PGA monotherapy: 17.3+/-3.8 mmHg; BTFC 1 month 13.2+/-3.3mmHg; p<0.05). This decrease from PGA-monotherapy IOP was sustained throughout the time-frame (6-month: 13.5+/-3.6mmHg; 12-month: 13.9+/-2.4mmHg; p<0.05 in pairwise comparison). There was no statistical difference in IOP between BTFC study visits (p>0.05). Of the 27 patients who had a satisfactory lOP-lowering response to BTFC after one month, 18 (66.7%) still had sufficient IOP control at the 12 month study visit. Therapy was discontinued at 1 month in 3 patients (2 due to intolerance to medication and 1 failing to achieve IOP control). No intolerability was reported beyond the 1 month of BTFC therapy.. In the majority of patients, the initial lOP lowering effect of replacing PGA monotherapy by BTFC seems to predict a long term response to the new treatment strategy.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Drug Combinations; Female; Humans; Intraocular Pressure; Ocular Hypertension; Prospective Studies; Timolol; Treatment Outcome

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

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

To compare the 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

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

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

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

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

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Timolol; Tonometry, Ocular; Treatment Outcome

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

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

To 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 evaluate the intraocular pressure (IOP)-lowering efficacy and safety of ophthalmic formulations of bimatoprost 0.01% and 0.0125% compared with bimatoprost 0.03%.. Prospective, randomized, double-masked, multicenter clinical trial.. Patients with glaucoma or ocular hypertension were randomized to receive once-daily bimatoprost 0.01% (n = 186), bimatoprost 0.0125% (n = 188), or bimatoprost 0.03% (n = 187) for 12 months. The primary efficacy measure was IOP. Safety measures included adverse events and an objective assessment of conjunctival hyperemia.. Baseline mean IOPs were similar among treatment groups. Differences in mean IOP between the bimatoprost 0.01% or 0.0125% groups and the bimatoprost 0.03% group were less than 0.9 mm Hg throughout follow-up. Bimatoprost 0.01%, but not bimatoprost 0.0125%, was equivalent in efficacy to bimatoprost 0.03% based on predetermined criteria (limits of the 95% confidence interval of the between-group difference in mean IOP within +/- 1.5 mm Hg at all time points and within +/- 1 mm Hg at most time points). The overall incidence of treatment-related adverse events was reduced significantly in the bimatoprost 0.01% and bimatoprost 0.0125% groups compared with the bimatoprost 0.03% group (P < or = .034). The percentage of patients with a moderate to severe increase from the baseline macroscopic hyperemia score was: bimatoprost 0.01%, 3.2%; bimatoprost 0.0125%, 9.0%; bimatoprost 0.03%, 9.1% (P = .019 for bimatoprost 0.01% vs 0.03%).. Bimatoprost 0.01% was equivalent to bimatoprost 0.03% in lowering IOP throughout 12 months of treatment and demonstrated improved tolerability, including less frequent and severe conjunctival hyperemia. Bimatoprost 0.01% demonstrated a better benefit-to-risk ratio than bimatoprost 0.0125%.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Patient Satisfaction; Prospective Studies; Surveys and Questionnaires; Tonometry, Ocular; Young Adult

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

To investigate the effects of topical bimatoprost (0.3 mg/ml)/timolol maleate (5 mg/ ml) fixed combination on retrobulbar blood flow in patients with ocular hypertension (OHT).. Twenty consecutive patients with OHT were prospectively randomised to either bimatoprost/timolol or placebo during a 12 weeks double masked treatment trial. Examinations were performed at baseline and after 12 weeks of treatment. Visual acuity, intraocular pressure (IOP), slit-lamp examination, automated static perimetry, systemic blood pressure and heart rate were all recorded. Retrobulbar blood flow measurements of the ophthalmic artery (AO) and central retinal artery (CRA) were measured by colour Doppler imaging.. IOP was significantly decreased by bimatoprost/timolol fixed combination (p < 0.0001). Bimatoprost/timolol fixed combination therapy resulted in a significant increase in end diastolic velocity (EDV) of the CRA (p = 0.03). In patients treated with bimatoprost/timolol a statistically significant correlation between IOP and EDV was observed after 12 weeks of treatment (r = -0.511, p = 0.045). The systolic (p = 0.54) and diastolic (p = 0.67) blood pressures and heart rate (p = 0.10) did not show statistically significant differences during the study period.. Topical bimatoprost/timolol fixed combination significantly reduced IOP in patients with OHT. However, the only significant change observed in retrobulbar haemodynamics was an increase in EDV of the CRA, probably associated with a reduction in IOP.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Combinations; Eye; Female; Humans; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Regional Blood Flow; Timolol; Ultrasonography, Doppler, Color

The aim of this study was to compare the efficacy of bimatoprost 0.03% with brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium:yttrium–aluminum–garnet (Nd:YAG) laser posterior capsulotomy.. In this prospective, randomized, double-masked study, 195 eyes of 195 consecutive patients who had YAG laser capsulotomy for posterior capsule opacification were recruited. Eyes received either 1 drop of bimatoprost 0.03% (98 patients) or brimonidine 0.2% (97 patients) at 1h before laser surgery. A masked observer measured IOP by Goldmann applanation tonometry before treatment and after treatment at 1h, 3h, 24h, and 7 days. Inflammation was evaluated after surgery. Formation of cystoid macular edema was assessed by measuring the macular thickness before and after laser surgery.. The average peak of postoperative IOP elevation was 2.2±3.9mm Hg in the bimatoprost 0.03% and 3.6±3.1mm Hg in the brimonidine 0.2% group. The difference was statistically significant (P<0.001). Postoperative IOP elevations of 10mm Hg or more occurred in 1 eye (1.56%) in the bimatoprost 0.03% group and 5 eyes (7.35%) in the brimonidine 0.2%. This difference was statistically significant (P<0.001). Macular edema and anterior chamber reaction were not observed related to bimatoprost. No clinically significant side effects were noted in either group.. Our results indicate that prophylactic use of bimatoprost 0.03% is more effective than brimonidine 0.2% in preventing IOP elevation immediately after YAG laser capsulotomy. Bimatoprost 0.03% as a prostamide analog may provide new option for preventing IOP elevation after YAG laser capsulotomy.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Capsule Opacification; Cataract; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Laser Therapy; Lasers, Solid-State; Male; Middle Aged; Neodymium; Ocular Hypertension; Ophthalmic Solutions; Posterior Capsule of the Lens; Quinoxalines; Tonometry, Ocular

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

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

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

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

Bimatoprost 0.03% has been shown to consistently reduce mean intraocular pressure (IOP) more than timolol 0.5% over 2 years. To further evaluate long-term safety and efficacy, once-daily bimatoprost 0.03% was compared with timolol 0.5% twice daily through year 4.. In this multicentre, double-masked, randomised, controlled trial, glaucoma and ocular hypertension patients (n = 152) who completed phase III bimatoprost trials through month 36 were enrolled in a study extension through month 48. Patients randomised to bimatoprost once daily (n = 78) or timolol twice daily (n = 35) continued on the same regimen for a fourth year. Patients randomised to bimatoprost twice daily had been switched to bimatoprost once daily dosing at month 24 (bimatoprost twice daily/once daily treatment group), and continued with once daily dosing through month 48 (n = 39). IOP was measured at 08:00 and 10:00 at months 39, 42, 45 and 48. Safety measures included adverse events, biomicroscopy, ophthalmoscopy, visual acuity and visual field.. Baseline IOP was comparable among groups. During year 4, mean IOP reductions from baseline were 7.0 to 8.1 mm Hg with bimatoprost once daily and 6.5 to 7.9 mm Hg with bimatoprost twice daily/once daily, significantly greater than with timolol twice daily (3.8 to 5.8 mm Hg, p< or =0.035) at all measurements. Over 4 years, the mean IOP reduction from baseline at 08:00 and 10:00 was 1.9 to 3.9 mm Hg (35% to 100%) greater with bimatoprost once daily than with timolol (p< or =0.013). Low IOPs were achieved by more bimatoprost than timolol patients (p< or =0.042). No safety concerns developed during long-term bimatoprost treatment; two patients in the timolol treatment group discontinued after month 36 because of adverse events. The most common treatment-related adverse event in the bimatoprost treatment groups was conjunctival hyperaemia.. Bimatoprost once daily provided sustained IOP lowering greater than timolol twice daily and was well tolerated over long-term use.

Topics: Amides; Analysis of Variance; Bimatoprost; Cloprostenol; Conjunctival Diseases; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Timolol; Treatment Outcome; Visual Acuity

An increase in intraocular pressure (IOP) frequently occurs after otherwise uneventful phacoemulsification cataract surgery. This study was conducted to determine the efficacy of bimatoprost 0.03% drops given preoperatively in preventing IOP rise following phacoemulsification cataract surgery.. In this prospective, randomized, double-masked, placebo-controlled study, 91 eyes of 85 patients scheduled to have clear corneal phacoemulsification cataract surgery were randomly divided into 2 groups. One hour before surgery, 1 group (48 eyes) received 1 drop of bimatoprost 0.03%, and the other group (43 eyes) received 1 drop of a balanced saline solution (placebo). A masked observer measured IOP preoperatively, and 3 and 24 hours postoperatively. Anterior chamber cellular reaction was measured on the first day after surgery. Preoperative and postoperative central corneal thickness (CCT) was assessed.. The mean IOP changes from baseline were not statistically different between the 2 groups at 3 hours (p = 0.618). At 24 hours, there was a statistically significant difference between the mean IOP changes of the groups (p = 0.001). The incidence of IOP elevation greater than 5 or 10 mm Hg at 24 hours was significantly higher in the control group (9 of 43 eyes) than the bimatoprost group (3 of 48 eyes) (p = 0.039). Anterior chamber reaction was not increased by bimatoprost. Mean CCT change was not different between the groups at 24 hours (p = 0.615).. When compared with placebo, prophylactic use of 1 drop of bimatoprost before phacoemulsification cataract surgery failed to produce a significantly different effect on IOP levels from placebo at 3 hours postoperatively, but it caused a significant IOP reduction at 24 hours.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Humans; Intraocular Pressure; Lens Implantation, Intraocular; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Phacoemulsification; Postoperative Complications; Prospective Studies; Time Factors; Tonometry, Ocular; Treatment Outcome

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

The aim of this study was to evaluate the incidence of hyperaemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperaemia.. This was a multicentre, open-label, evaluator-masked clinical trial of 106 patients. Prior to enrolling in the trial, patients were washed out from any ocular hypotensive medications and prescribed bimatoprost daily in the evening for 6 weeks. Patients were randomised to one of two groups: intervention and no intervention. Patients in the intervention group (n=63) were given a fact sheet explaining the importance of reducing intraocular pressure (IOP) and the efficacy of bimatoprost, while patients in the no intervention group (n=43) were instructed only to instil bimatoprost daily and were given no additional instructions.. As graded by the masked investigators, conjunctival hyperaemia peaked 1 day after commencing bimatoprost, with a mean of 1.2 (0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe). By day 7, hyperaemia levels were approximately trace (0.79) and continued to decrease throughout the study. There were no significant differences between groups in mean conjunctival hyperaemia at any study visit (P> or =0.215). At every visit, patients in the intervention group were significantly more likely than patients in the no intervention group to report that lowering IOP was very important for preserving vision (P< or =0.001). At week 6, 98% of patients in the intervention group reported that IOP-lowering was very important for preserving vision, compared with 76% of patients who did not receive the intervention (P< or =0.001). Patients in the intervention group were more likely than patients in the no intervention group to be willing to continue to use bimatoprost, despite hyperaemia. This difference was statistically significant at day 1 (P=0.003).. Patients were not bothered by the trace.mild hyperaemia associated with bimatoprost therapy. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Male; Ocular Hypertension; Patient Compliance; Patient Education as Topic

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

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

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

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

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

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

To evaluate the effect of bimatoprost 0.03% on intraocular pressure (IOP) after phacoemulsification in eyes with exfoliation syndrome.. This prospective, randomized, masked study comprised 90 eyes of 90 patients scheduled for phacoemulsification. The patients were divided into three groups (group 1 = without exfoliation, group 2 = with exfoliation syndrome, group 3 = exfoliation syndrome + bimatoprost). Immediately after phacoemulsification, one drop of bimatoprost was instilled in eyes in group 3. Baseline IOP was measured 1 day before surgery and routine follow-ups were performed at 6 hours, 20-24 hours and 1 week postoperatively.. Preoperative IOP was 15.0 +/- 2.7 mmHg in group 1, 15.6 +/- 3.2 mmHg in group 2 and 16.1 +/- 3.2 mmHg in group 3 (p = 0.372). Six hours postoperatively, there was a significant difference between the groups (p = 0.013): IOP in group 2 (22.4 +/- 7.3 mmHg) was higher than in group 1 (18.4 +/- 4.4 mmHg) (p = 0.018) and group 3 (18.9 +/- 4.9 mmHg) (p = 0.044). In all groups, IOP values at 6 hours postoperatively were higher than preoperative values (p < 0.001), but IOP values at 20-24 hours and 1 week after surgery were not significantly different from baseline values (p > 0.05). The change in IOP in group 2, from baseline to 6 hours postoperatively, was greater than the equivalent changes in group 1 (p = 0.048) and group 3 (p = 0.016).. Transient IOP increase and spikes were more common in eyes with exfoliation syndrome. Postoperative application of bimatoprost was effective in reducing IOP and preventing IOP spikes >/= 30 mmHg in eyes with exfoliation syndrome in the early postoperative period.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Exfoliation Syndrome; Female; Humans; Intraocular Pressure; Lens Implantation, Intraocular; Lipids; Male; Ocular Hypertension; Ophthalmic Solutions; Phacoemulsification; Postoperative Care; Prospective Studies

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

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

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

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

To 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

To investigate the efficacy of reducing the drop-skin contact to prevent dermatologic side effects of bimatoprost 0.03% topical therapy.. Prospective, randomized, single-blinded, internally controlled study.. Enrolled subjects started bimatoprost 0.03% therapy once at night in both eyes and were instructed to wipe selectively only one eye (eye 1) with an adsorbent pad during and after drops administration for four months. The fellow eye acted as the internal control. Eyelash growth, regional skin hypertrichosis, and pigmentation on the periocular skin were assessed at baseline and during the four months of follow-up.. A lower incidence of eyelash growth and skin pigmentation in the inferonasal pericanthal region were observed in eye 1. The incidence of pigmentation in the inferotemporal skin region and skin hypertrichosis were similar in the two eyes.. The reduction of the drop-skin contact affects the regional incidence and the extent of dermatologic skin changes that are related to bimatoprost 0.03% topical therapy.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Disposable Equipment; Eyelashes; Eyelid Diseases; Female; Glaucoma; Hair Diseases; Humans; Hyperpigmentation; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Ophthalmology; Prospective Studies; Single-Blind Method; Skin Care; Skin Pigmentation

To determine if the intraocular pressure (IOP) effect of pilocarpine at various concentrations is additive to that of bimatoprost and to assess the tolerability of this combination.. This was a randomized, prospective trial of patients with IOP > 21 mm Hg following appropriate medication washout. For all visits IOP was measured at 9:00 AM and 11:00 AM. Following baseline visit (#1), bimatoprost 0.03% was instilled qhs OU through visit 6. Following visits 2, 3, and 4 pilocarpine (2%, 4%, 6%) was instilled qid in one randomly selected eye. Pilocarpine was discontinued after visit 5 and bimatoprost after visit 6. Two-tailed, paired t test was used to compare treated and contralateral eyes for their IOP, IOP change, percentage IOP change from baseline, and to compare IOP in the same eye at 9:00 AM and 11:00 AM (before and after pilocarpine administration). IOPs using bimatoprost alone or in combination with various pilocarpine concentrations were compared using single variant Analysis of Variance (ANOVA).. Seventeen patients were enrolled and 13 patients completed the study. Bimatoprost reduced IOP 28.7% to 30.5% (P < 0.0001) from baseline to visit 2. IOPs in eyes treated with bimatoprost alone or with bimatoprost and various pilocarpine concentrations were similar (P > 0.81, ANOVA). The IOP (P > 0.17) and percentage IOP change from baseline (P > 0.10) was similar in treated and contralateral eyes with all three strengths of pilocarpine. IOP values at 9:00 AM and 11:00 AM, before and after pilocarpine administration, were similar (P > 0.22).. Bimatoprost alone reduces IOP substantially. Pilocarpine added to bimatoprost at concentrations of 2%, 4%, or 6% was neither additive nor antagonistic to the ocular hypotensive efficacy of bimatoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Synergism; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Pilocarpine; Prospective Studies

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

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

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

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

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

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

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

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

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

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

To evaluate the intraocular pressure- (IOP-) lowering efficacy of bimatoprost 0.03% (Lumigan, Allergan, Inc.) monotherapy in the treatment of patients with glaucoma or ocular hypertension not currently using ocular hypotensives.. Open-label, community-based, multicenter evaluation. Patients (n = 6767) who, according to their physicians, required IOP lowering were prescribed bimatoprost for 2 months. Subgroup analyses of the results, stratified by treatment history and use of concomitant medications, were performed. This report focuses on the subgroup of patients that was not being treated with antiglaucoma medications at baseline (n = 1946, 29%). All of these patients were placed on bimatoprost monotherapy.. The mean IOP at the untreated baseline was 23.8 mmHg. Bimatoprost provided a mean IOP reduction of 7.5 mmHg (30%, p < 0.001) from baseline after 2 months of monotherapy. Further, bimatoprost allowed patients to achieve low target pressures. For example, 41.5% of patients achieved target IOPs of < or =15 mmHg after 2 months of bimatoprost monotherapy, and 75.8% of patients reached IOPs of < or =18 mmHg. The most commonly reported adverse event was conjunctival hyperemia (7.9%).. Bimatoprost monotherapy was well tolerated and reduced IOP by an average of 30% in a large population of untreated patients.

Topics: Amides; Bimatoprost; Cloprostenol; Female; Glaucoma; Humans; Instillation, Drug; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Treatment Outcome

To determine the mechanism of ocular hypotensive action of bimatoprost in patients with ocular hypertension or glaucoma.. Double-masked, placebo-controlled, randomized, paired comparison crossover study of the effect of bimatoprost on aqueous humor dynamics.. Twenty-nine patients with ocular hypertension or glaucoma.. Bimatoprost and a placebo were administered once a day, in the evening, for 7 days before assessment of aqueous dynamics using tonometry, Schiötz tonography, and fluorophotometry. Intraocular pressure (IOP) response to water drinking was measured.. Aqueous humor flow rate, outflow facility, and IOP.. Intraocular pressure was lowered 29% in the morning and 33% at noon by bimatoprost. Aqueous humor flow was unchanged. Tonographic facility of outflow was increased 47% by bimatoprost relative to the placebo. Assuming an extraocular pressure of 8 mmHg and that extraocular pressure is not altered by bimatoprost, the calculated rate of pressure-insensitive outflow was increased 95% by bimatoprost. During the first hour after water drinking, bimatoprost dampened the IOP rise.. As was seen in healthy normal eyes, bimatoprost increased both the pressure-sensitive and the pressure-insensitive outflows of aqueous humor in patients with ocular hypertension or glaucoma. Bimatoprost had no significant effect on aqueous humor formation.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Fluorophotometry; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Tonometry, Ocular

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

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

To evaluate the safety and efficacy of bimatoprost 0.03% once daily or twice daily compared with timolol 0.5% twice daily in patients with glaucoma or ocular hypertension.. Multicentre, double masked, randomised, parallel group, 3 month trial comparing bimatoprost once daily (n=240), bimatoprost twice daily (n=240), and timolol twice daily (n=122). The primary efficacy end point was diurnal intraocular pressure (IOP) (8 am, 10 am, 4 pm). Safety measures included adverse events, ocular parameters, and systemic variables.. Bimatoprost once daily provided significantly lower mean IOP than timolol twice daily at all times and follow up visits (p<0.001). At month 3, mean IOP reductions from baseline at 10 am (peak timolol effect) were bimatoprost once daily, 8.0 mm Hg (32.4%); bimatoprost twice daily, 6.3 mm Hg (25.2%); timolol, 5.5 mm Hg (22.7%). Bimatoprost twice daily was also more effective than timolol, but was not as effective as bimatoprost once daily. A higher percentage of patients achieved low target pressures with bimatoprost once daily than with timolol. The most frequent side effects with bimatoprost were eyelash growth and mild conjunctival hyperaemia. Systemic safety parameters were not affected by bimatoprost.. Bimatoprost 0.03% once daily demonstrated superior efficacy compared with timolol 0.5% twice daily in patients with elevated IOP. Bimatoprost once daily was more effective than twice daily dosing.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Timolol; Treatment Outcome

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

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

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

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

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

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

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

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

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

To compare the efficacy and safety of topical bimatoprost (LUMIGAN; Allergan, Inc., Irvine, CA) once daily with that of topical combined timolol and dorzolamide (Cosopt; Merck and Co, Inc., Whitehouse Station, NJ) twice daily.. Prospective, randomized, double-masked, multicenter clinical trial.. One hundred seventy-seven patients with a diagnosis of glaucoma or ocular hypertension and inadequate control of intraocular pressure (IOP) after at least 2 weeks of topical timolol maleate 0.5% monotherapy.. Patients were randomized to receive bimatoprost 0.03% once daily (n = 90) or combined timolol 0.5% and dorzolamide 2% twice daily (n = 87) over a 3-month period.. Intraocular pressure, the primary end point, was measured at 8 AM and 10 AM at baseline, week 1, and months 1, 2, and 3, and also at 4 PM and 8 PM at baseline and month 3.. Bimatoprost provided significantly greater IOP lowering compared with combined timolol and dorzolamide. At the 8 AM measurements, bimatoprost lowered mean IOP 6.8 mmHg to 7.6 mmHg from baseline, whereas combined timolol and dorzolamide lowered mean IOP 4.4 to 5.0 mmHg from baseline (P<0.001). At the last follow-up, patients had better diurnal IOP control with bimatoprost than combined timolol and dorzolamide. At 8 AM at the 3-month visit, the percentages of patients achieving IOPs of

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Safety; Sulfonamides; Thiophenes; Timolol

To compare bimatoprost with timolol maleate in patients with glaucoma or ocular hypertension.. In 2 identical, multicenter, randomized, double-masked, 1-year clinical trials, patients were treated with 0.03% bimatoprost once daily (QD) (n = 474), 0.03% bimatoprost twice daily (BID) (n = 483), or 0.5% timolol maleate BID (n = 241).. Diurnal intraocular pressure (IOP) at 8 AM, 10 AM, and 4 PM and safety variables (IOP was also measured at 8 PM at selected sites).. Bimatoprost QD provided significantly lower mean IOP than timolol at every time of the day at each study visit (P<.001). This was also true for bimatoprost BID at most time points, but the efficacy was not as good as that of the QD regimen. At 10 AM (peak timolol effect) at month 12, the mean reduction in IOP from baseline was 7.6 mm Hg (30%) with bimatoprost and 5.3 mm Hg (21%) with timolol (P<.001). A significantly higher percentage of patients receiving bimatoprost QD (58%) than timolol (37%) achieved IOPs at or below 17 mm Hg (10 AM, month 12; P<.001). The most common adverse effect with bimatoprost was hyperemia (significantly higher with bimatoprost QD than timolol; P<.001).. Bimatoprost QD provides sustained IOP lowering superior to timolol or bimatoprost BID and achieves low target IOPs in significantly more patients.

Topics: Adrenergic beta-Antagonists; Aged; Amides; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Safety; Timolol; Treatment Outcome

To compare the safety, tolerability, and efficacy of bimatoprost 0.03% instilled once daily or twice daily with timolol 0.5% twice daily.. Multicenter, 3-month, randomized, double-masked, interventional comparison trial.. Patients diagnosed with ocular hypertension or glaucoma (n = 596).. Patients received bimatoprost 0.03% ophthalmic solution once daily (8 PM, with vehicle control at 8 AM), bimatoprost 0.03% twice daily (8 AM; 8 PM), or timolol 0.5% twice daily (8 AM; 8 PM) in an uneven 2:2:1 randomization. Scheduled visits were at prestudy, baseline (day 0), weeks 2 and 6, and month 3. Intraocular pressure (IOP) was measured at 8 AM (predose), 10 AM, and 4 PM.. The primary outcome measure was reduction in IOP in the eye with higher IOP at baseline. Secondary outcome measures included safety variables (adverse events, ophthalmoscopy, biomicroscopy, iris pigmentation, laser-flare meter, visual acuity, visual fields, heart rate, blood pressure, blood chemistry, hematology, and urinalysis).. At month 3, the mean reduction in IOP from baseline at 8 AM was 9.16 mmHg (35.2%) with bimatoprost once daily, 7.78 mmHg (30.4%) with bimatoprost twice daily, and 6.74 mmHg (26.2%) with timolol twice daily. At all follow-up visits, mean IOP reductions were significantly greater in the bimatoprost once daily group than in the timolol group at each time point (8 AM, 10 AM, and 4 PM; P < 0.001). Twice-daily dosing of bimatoprost also provided significantly greater mean reductions in IOP than timolol at most time points but was not as effective as once-daily dosing. Bimatoprost was associated with significantly more hyperemia and eyelash growth than timolol, whereas timolol was associated with significantly more burning and stinging sensation in eyes. Overall, bimatoprost was well tolerated with few discontinuations because of adverse events.. Bimatoprost 0.03% once daily was safe and statistically superior to timolol 0.5% twice daily in lowering IOP in patients with ocular hypertension or glaucoma. Bimatoprost given once daily consistently provided IOP reductions approximately 2 to 3 mmHg greater than those provided by timolol. Once-daily dosing of bimatoprost, 0.03%, demonstrated greater IOP-lowering effect and better ocular tolerability than twice-daily dosing.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Hemodynamics; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Treatment Outcome; Visual Acuity; Visual Fields

The efficacy and safety of bimatoprost, a member of a new class of pharmacological agents called prostamides, were compared with the efficacy and safety of timolol in patients with glaucoma or ocular hypertension. Pooled 6-month results from two ongoing, multicenter, randomized, double-masked, clinical trials were analyzed. Patients were randomized in a 2:2:1 ratio to treatment with bimatoprost 0.03% once a day ([QD] n = 474), bimatoprost 0.03% twice a day ([BID] n = 483), or timolol 0.5% BID (n = 241). Scheduled visits were at prestudy, baseline, week 2, week 6, month 3, and month 6. The primary outcome measure was in diurnal intraocular pressure ([IOP] 8 AM, 10 AM, 4 PM, 8 PM). Bimatoprost QD provided significantly greater mean IOP reductions from baseline than timolol at every time of the day and at each study visit (p

Topics: Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Double-Blind Method; Eye Color; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Iris; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol

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

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

To compare the safety and efficacy of the ocular hypotensive lipid AGN 192024 (Lumigan) with those of timolol.. A 30-day, randomized, investigator-masked, clinical trial involving 100 patients with elevated intraocular pressure (IOP). Study medications were instilled topically. Doses of 0.003%, 0.01%, or 0.03% AGN 192024 were given once daily for 3 weeks then twice daily for 1 week, and vehicle control or 0.5% timolol was given twice daily for 4 weeks. Mean change in IOP from baseline was the primary efficacy variable. Safety parameters included adverse events, hyperemia grading, laser flare meter analysis, heart rate, and blood pressure.. Timolol and all 3 concentrations of AGN 192024 lowered IOP from baseline (P < .001). A dosage of 0.03% AGN 192024 once daily lowered IOP significantly more than timolol (P < or = .02) at every study visit except day 21 (P = .053) and provided better diurnal IOP control. Twice-daily dosing of AGN 192024 provided no clinically significant benefit over once-daily dosing. All treatment regimens were safe and well tolerated, with no clinically significant effects on heart rate or blood pressure and no between-group differences in the incidence of adverse events. The only significant ocular safety finding with AGN 192024 was a dose-related mild increase in conjunctival hyperemia.. Of the 3 concentrations tested, 0.03% AGN 192024 once daily had the best therapeutic profile. AGN 192024 was safe and well tolerated, and it provided superior ocular hypotensive efficacy and diurnal IOP control compared with timolol in patients with ocular hypertension and glaucoma.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Evaluation; Female; Hemodynamics; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Retrospective Studies

Topics: Animals; Bimatoprost; Delayed-Action Preparations; Dogs; Intraocular Pressure; Laser Therapy; Lasers; Ocular Hypertension; Trabeculectomy; Treatment Outcome

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

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

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

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

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

In randomized, controlled trials of open-angle glaucoma (OAG) or ocular hypertension (OHT), bimatoprost 0.01 % improved tolerability while retaining the intraocular pressure (IOP)-lowering efficacy of bimatoprost 0.03 %. Given geographic/racial differences in glaucoma presentation, the APPEAL study assessed the occurrence and severity of hyperemia produced by bimatoprost 0.01 %, and its efficacy, in the Taiwanese clinical setting.. In this multicenter, open-label, observational study, treatment-naïve and previously treated patients with OHT or OAG received once-daily bimatoprost 0.01 % for 12 weeks. Hyperemia (primary endpoint) was graded at baseline, week 6, and week 12 using a photonumeric scale (0, +0.5, +1, +2, +3), grouped (≤ +1, none to mild; ≥ +2, moderate to severe), and reported as unchanged from baseline, improved, or worsened. IOP assessments followed the same schedule. Supplemental efficacy analyses were conducted based on previous therapies.. The intent-to-treat population (N = 312) included treatment-naïve (13.5 %) and previously treated (86.5 %) patients; mean age was 53.3 years. At baseline, 46.3 % of previously treated patients were receiving prostaglandin analog (PGA) monotherapy. At week 12, 91.2 %, 5.9 %, and 2.9 % of treatment-naïve patients exhibited unchanged, worsened, and improved hyperemia from baseline, respectively; 77.9 %, 12.9 %, and 9.2 % of previously treated patients showed no change, worsening, and improvement, respectively. There were no statistically significant shifts in hyperemia severity in either group, or in subgroups based on previous use of any PGA, any non-PGA, latanoprost, or travoprost monotherapies. In treatment-naïve patients, mean IOP reduction from baseline (18.0 ± 3.8 mm Hg) was 3.6 mm Hg at week 12 (P < 0.0001); 83.3 % had baseline IOP ≤ 21 mm Hg. In previously treated patients, mean additional IOP reduction from baseline (17.8 ± 3.9 mm Hg) was 2.6 mm Hg (P < 0.0001); similar results were observed in patient subgroups based on previous therapies.. In the Taiwanese clinical setting, bimatoprost 0.01 % provided significant IOP lowering in treatment-naïve patients (regardless of baseline IOP) and previously treated patients (even those with relatively low IOP on other therapies), while causing no significant changes in hyperemia from baseline.. Clinicaltrials.gov NCT01814761 . Registered 18 March 2013.

Topics: Adult; Aged; Antihypertensive Agents; Bimatoprost; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intention to Treat Analysis; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension

To evaluate the occurrence of hyperemia with, and efficacy of, bimatoprost 0.01 % for patients in Korea previously treated for open-angle glaucoma (OAG; including normal tension glaucoma) or ocular hypertension (OHT).. In this multicenter, observational study (Asia Pacific Patterns from Early Access of Lumigan 0.01 % in Korea; APPEAL Korea), patients with unachieved target intraocular pressure (IOP) despite previous treatment received bimatoprost 0.01 % daily for 12 weeks. The primary endpoint was incidence of hyperemia and its severity, graded using the standard 5-point photographic scale and grouped as "none to mild" and "moderate to severe". Hyperemia shifts were reported. IOP and adverse events (AEs) were recorded.. Of 800 patients (intent-to-treat/safety population), 248 were switched from previous treatment to bimatoprost 0.01 % monotherapy. Hyperemia shifts from baseline at weeks 6 and 12 were unchanged (84.8, 89.8 %), improved (4.4, 4.8 %), or worsened (10.8, 5.4 %), respectively. The shift was significant at week 6 (P < 0.0001). Hyperemia did not worsen significantly in patients previously receiving a prostaglandin analog or prostamide (PGA/PSD). Baseline mean IOP ± SD was 17.0 ± 5.7 mmHg, decreasing to 14.6 ± 3.8 mmHg (P < 0.0001) after 6 weeks, and to 14.7 ± 3.6 mmHg (P < 0.0001) after 12 weeks. Patients switched from PGA or PSD (excluding bimatoprost 0.03 %) to bimatoprost 0.01 % experienced significant IOP reductions from baseline. Treatment-related ocular AEs were reported by 37 patients, the most common being hyperemia (7.3 %).. This subanalysis of the APPEAL Korea study supports use of bimatoprost 0.01 % for previously treated patients with OAG (including normal tension glaucoma) or OHT who did not reach target IOP or were intolerant of previous treatment.

Topics: Administration, Topical; Aged; Antihypertensive Agents; Asian People; Bimatoprost; Conjunctiva; Drug Substitution; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Republic of Korea; Single-Blind Method; Tonometry, Ocular

To evaluate the periocular changes due to topical bimatoprost and latanoprost use and to investigate their effects on the lacrimal drainage system.. All participants (69 eyes of 43 patients, 52 eyes of 26 controls) were classified into three groups: bimatoprost (0.03%) users, latanoprost (0.005%) users, and healthy controls. Each patient was examined before prostaglandin therapy, and then at the first, third, sixth, and twelfth month of therapy. Palpebral fissure height, upper eyelid crease, and levator function were measured, and lacrimal system drainage irrigation was performed. Periocular hyperpigmentation and upper eyelid sulcus were also examined.. No significant change was identified in palpebral fissure height or levator function in any group. However, in upper eyelid crease, among bimatoprost users, a statistically significant increase was observed when compared to the control group (P < 0.001). Patients with skin type II and III, in bimatoprost users, and patients with skin type III, in latanoprost users, had statistically significant hyperpigmentation (P < 0.001) after the third month of therapy. During follow-up, no lacrimal drainage system obstruction was seen.. Topical bimatoprost therapy causes more periocular changes than latanoprost therapy. Thus, in unilateral cases, patients should be well informed about these probable changes before therapy.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Hyperpigmentation; Incidence; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Turkey

The prostaglandin F2alpha (PGF2α) analogue bimatoprost lowers intraocular pressure (IOP) by increasing uveoscleral outflow at doses shown to elicit redness of the eye. With the aim to enhance the IOP-lowering effect of bimatoprost we studied NCX 470 [(S,E)-1-((1R,2R,3S,5R)-2-((Z)-7-(ethylamino)-7-oxohept-2-enyl)-3,5-dihydroxycyclopentyl)-5-phenylpent-1-en-3-yl 6-(nitrooxy)hexanoate], a dual-acting compound combining bimatoprost with nitric oxide (NO) known to mainly act via relaxation of trabecular meshwork and Schlemm's canal.. New Zealand white rabbits with transient hypertonic saline-induced IOP elevation (tOHT-rabbits), cynomolgus monkeys with laser-induced ocular hypertension (OHT-monkeys), and normotensive dogs (ONT-dogs) were used. The levels of NCX 470, bimatoprost, and bimatoprost acid were determined in aqueous humor (AH), cornea (CR), and iris/ciliary body (ICB) by liquid chromatography-mass spectrometry/mass (LC-MS/MS), while cGMP in AH and ICB was monitored using an enzyme immunoassay (EIA) kit in pigmented Dutch Belted rabbits.. NCX 470 (0.14%, 30 μL) lowered IOP in tOHT-rabbits with an E(max) of -7.2 ± 2.8 mm Hg at 90 minutes. Bimatoprost at equimolar dose (0.1%, 30 μL) was noneffective in this model. NCX 470 (0.042%, 30 μL) was more effective than equimolar (0.03%, 30 μL) bimatoprost in ONT-dogs (IOP change, -5.4 ± 0.7 and -3.4 ± 0.7 mm Hg, respectively, P < 0.05) and in OHT-monkeys (IOP change, -7.7 ± 1.4 and -4.8 ± 1.7 mm Hg, respectively, P < 0.05) at 18 hours post dosing. NCX 470 (0.042%, 30 μL) or bimatoprost (0.03%, 30 μL) resulted in similar bimatoprost acid exposure in AH, CR, and ICB while cGMP was significantly increased in AH and ICB at 18 and 24 hours after NCX 470 dosing.. NCX 470 lowers IOP more than equimolar bimatoprost in three animal models of glaucoma by activating PGF2α and NO/cGMP signaling pathways.

Topics: Animals; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Ciliary Body; Disease Models, Animal; Dogs; Intraocular Pressure; Macaca fascicularis; Male; Nitric Oxide Donors; Ocular Hypertension; Rabbits; Tandem Mass Spectrometry

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

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

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

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

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

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

Topics: Adolescent; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Humans; Ocular Hypertension; Retinal Detachment; Sturge-Weber Syndrome; Treatment Outcome; Visual Acuity

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

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

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

The IOP lowering effects of NCX 139, a new chemical entity comprising latanoprost amide and a NO-donating moiety, were compared to those of the respective des-nitro analog in in vitro assays and in rabbit and dog models of ocular hypertension. The NO donor, molsidomine as well as the prostamide bimatoprost (Lumigan(®)) and the prostaglandin agonist, latanoprost (Xalatan(®)) were also investigated for comparison. NCX 139 but not its des-nitro analog resulted in NO-mediated vascular relaxant effect in pre-contracted rabbit aortic rings (EC(50)=0.70±0.06 μM; E(max)=80.6±2.9%). Like bimatoprost (IC(50)=3.07±1.3 μM) or latanoprost (IC(50)=0.48±0.15 μM), NCX 139 displaced (3)H-PGF2α binding on recombinant human prostaglandin-F (FP) receptors with an estimated potency of 0.77±0.13 μM. In transient ocular hypertensive rabbits, bimatoprost and latanoprost were not effective while molsidomine elicited a dose-dependent reduction of IOP confirming the responsiveness of rabbits to NO but not to FP receptor agonists. NCX 139 tested at a therapeutically relevant dose, significantly lowered IOP while the des-nitro analog was not effective (0.03% NCX 139, Δ(max)=-12.8±2.0 mmHg). In glaucomatous dogs, 0.03% NCX 139 decreased IOP to a greater extent compared to an equimolar dose of the respective des-nitro derivative (Δ(max)=-4.6±1.0 and -2.7±1.3 mmHg, respectively for NCX 139 and its des-nitro analog). Albeit with low potency, NCX 139 also resulted effective in normotensive dogs while it did not reduce IOP in normotensive rabbits. NCX 139, a compound targeting two different and important mechanisms, is endowed with ocular hypotensive effects more evident in hypertensive conditions which may be of interest in the search of more effective treatments for hypertensive glaucoma.

Topics: Amides; Animals; Antihypertensive Agents; Aorta; Bimatoprost; Chromatography, High Pressure Liquid; Cloprostenol; Dinoprost; Disease Models, Animal; Dogs; Glaucoma; Intraocular Pressure; Latanoprost; Male; Molsidomine; Nitrates; Nitric Oxide; Nitric Oxide Donors; Ocular Hypertension; Prostaglandins F, Synthetic; Rabbits; Tandem Mass Spectrometry; Tonometry, Ocular; Vasodilation; Vasodilator Agents

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Although the probability of treatment success should be the primary factor guiding the choice of an intraocular pressure (IOP)-lowering medication, treatment cost is also important to physicians, patients and third-party payers. The objective of the present study was to compare the cost effectiveness of bimatoprost with that of latanoprost in the treatment of glaucoma and ocular hypertension.. Estimated yearly costs and cost per treatment success for bimatoprost ophthalmic solution 0.03% once daily (Lumigan), Allergan, Inc., Irvine, CA, USA) were compared with those for latanoprost ophthalmic solution 0.005% once daily (Xalatan), Pfizer, Inc., New York, NY, USA). The pharmacoeconomic model was based on medical resource costs and the percentage of patients achieving > or =20% decrease in IOP from baseline at 8:00 am, 12:00 pm and 4:00 pm after 6 months of treatment (clinical success rate). Calculations were also made using the average success rate throughout the day and the average success rate minus the percentage of patients who withdrew from treatment as a result of adverse events.. After 6 months of treatment, the clinical success rates were significantly higher with bimatoprost than with latanoprost (p < or = 0.003). The average expected yearly cost per patient was similar for bimatoprost (US1151 dollars) and latanoprost (US1193 dollars). The cost per treatment success, however, averaged US568 dollars less with bimatoprost (US1501 dollars/success) than with latanoprost (US2069 dollars/success). This was true even when the percentage of patients who withdrew from treatment as a result of adverse events was subtracted from the clinical success rate.. The greater efficacy of bimatoprost resulted in a lower cost per treatment success than was seen with latanoprost. This remained true even when responder rates were adjusted by subtracting the percentage of patients who withdrew from treatment as a result of adverse events.

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

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

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Sulfonamides; Thiophenes; Timolol

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

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

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

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

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

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

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

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

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

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

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

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, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic

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

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

Topics: Amides; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Safety; Timolol