A 3-month randomized controlled trial of bimatoprost (LUMIGAN) versus combined timolol and dorzolamide (Cosopt) in patients with glaucoma or ocular hypertension

PURPOSE: 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. DESIGN: Prospective, randomized, double-masked, multicenter clinical trial. PARTICIPANTS: 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. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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 相似文献   

A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma

PURPOSE: To compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with latanoprost 0.005%. DESIGN: Multicenter, randomized, investigator-masked clinical trial. METHODS: 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. RESULTS: 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. CONCLUSIONS: Bimatoprost is more effective than latanoprost in lowering IOP. Both drugs were well tolerated, with few discontinuations for adverse events.     

Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial

OBJECTIVE: To compare the safety, tolerability, and efficacy of bimatoprost 0.03% instilled once daily or twice daily with timolol 0.5% twice daily. DESIGN: Multicenter, 3-month, randomized, double-masked, interventional comparison trial. PARTICIPANTS: Patients diagnosed with ocular hypertension or glaucoma (n = 596). INTERVENTION: 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. MAIN OUTCOME MEASURES: 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). RESULTS: 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. CONCLUSIONS: 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.     

Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension

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.     

Effect of changing from concomitant timolol pilocarpine to bimatoprost monotherapy on ocular blood flow and IOP in primary chronic angle closure glaucoma.

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

Intraocular pressure-lowering efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension

AIM: To evaluate the efficacies of bimatoprost and travoprost for lowering of intraocular pressure (IOP) for the treatment of glaucoma and ocular hypertension. METHODS: 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. RESULTS: 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. CONCLUSIONS: Bimatoprost provided greater mean IOP reductions than travoprost.     

Comparison of the ocular hypotensive effects of bimatoprost and timolol-dorzolamide combination in patients with elevated intraocular pressure: a 6-month study

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.     

A randomised,double masked,multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension

Aim: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.     

Bimatoprost in the treatment of ocular hypertension and chronic glaucoma

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.     

Additivity of pilocarpine to bimatoprost in ocular hypertension and early glaucoma

PURPOSE: 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. METHODS: 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). RESULTS: 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). CONCLUSION: 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.     

Effect of bimatoprost on patients with primary open-angle glaucoma or ocular hypertension who are nonresponders to latanoprost

PURPOSE: 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. DESIGN: Prospective, randomized clinical trial with a cross over design (two 30-day treatment phases with a 30-day washout phase in between). PARTICIPANTS: Fifteen patients were enrolled. Random allocation to treatment to a single eye only of every subject. Eligibility criteria: (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. METHOD: 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"). MAIN OUTCOME MEASURE: IOP. RESULTS: 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). CONCLUSIONS: 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.     

Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension.

PURPOSE: 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. METHODS: 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). RESULTS: 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). CONCLUSION: 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.     

The effects of prostaglandin analogues on the blood aqueous barrier and corneal thickness of phakic patients with primary open-angle glaucoma and ocular hypertension

PURPOSE: 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). DESIGN: Prospective, randomized, masked-observer, crossover clinical trial. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.     

Intraocular pressure lowering efficacy of travoprost

PURPOSE: To assess the intraocular pressure lowering effect of travoprost 0.004% in patients previously treated with another topical medication, and in previously untreated patients. METHODS: This 12-week, open-label trial in 1590 patients was conducted at 219 sites in Switzerland. Primary open-angle glaucoma and ocular hypertension patients discontinued prior medications, and instilled 1 drop of travoprost in each affected eye at 8 pm. Untreated patients were subdivided into 2 groups: baseline IOP of > or = 21 mmHg, and baseline IOP of < or = 20 mmHg. Patients returned for follow-up visits at 1 and 3 months. The primary outcome was mean IOP change from baseline to follow-up. RESULTS: Of 626 patients previously on monotherapy, and 525 previously untreated or newly-diagnosed patients, 479 and 423, respectively, completed 3 months of therapy. The mean changes from baseline at 1 month (mmHg +/- SD), by prior treatment group were: beta blocker, -4.9 (+/- 3.6); latanoprost, -2.3 (+/- 2.8); alpha-agonist, -4.0 (+/- 3.7); dorzolamide/timolol fixed combination, -3.4 (+/- 3.9); topical CAI, -4.4 (+/- 3.1); new IOP > or = 21 mmHg, -8.6 (+/- 4.4); new IOP < or = 20 mmHg, -4.4 (+/- 3.0). (All changes from baseline were statistically significant (p < 0.0001). CONCLUSIONS: In patients previously treated with a single drug, travoprost decreased IOP to pressures below those achieved on prior therapy. In all groups, travoprost reduced mean IOP below 18 mmHg within 1 month of starting therapy, and control was maintained for at least 3 months. Overall, travoprost was safe and well-tolerated.     

Effects of bimatoprost 0.03% on ocular hemodynamics in normal tension glaucoma.

PURPOSE: The aim of this study was to investigate the effects of bimatoprost 0.03% on ocular hemodynamics in patients with normal tension glaucoma (NTG). METHODS: Twenty-two (22) patients with NTG were consecutively recruited. After basic eye examination and diurnal intraocular pressure (IOP) measurement, color Doppler imaging was used to measure the peak systolic and end diastolic velocities and resistive index of the central retinal, lateral posterior ciliary, and medial posterior ciliary arteries. Patients received bimatoprost 0.03% for 4 weeks, and these measurements were then repeated. The worse eye of each NTG patient was used in the statistical analysis. RESULTS: Bimatoprost 0.03% significantly reduced mean IOP from 15.1 +/- 3.8 mmHg at baseline to 12.0 +/- 2.9 mmHg after treatment in our sample of NTG patients (P < 0.001). No significant changes in blood velocities or resistance indices were observed in the retrobulbar vessels after the 4-week treatment. CONCLUSIONS: Topical bimatoprost 0.03% significantly reduced IOP in our NTG patients without causing significant hemodynamic changes in the retrobulbar vessels.     

卢美根与噻吗心安治疗高眼压疗效对比的Meta分析

目的研究卢美根与噻吗心安在青光眼与高眼压症患者中降压的有效性,并观察不良反应。方法检索PubMed、EMBASE、The Cochrane Library Controlled Trials Register及中国生物医学文献数据库收录的有关卢美根与噻吗心安治疗青光眼与高眼压症的对照研究,并辅以手工检索、因特网搜索。对纳入的6项随机对照试验,针对眼压下降比例、达到目标眼压人数、药物不良反应3项内容进行综合分析。结果卢美根降眼压效果优于噻吗心安,差异有统计学意义（P〈0.01）[合并的加权均数差（WMD）=-2.04%,95%CI（-2.44,-1.64）]。3篇文献报道随访3个月时达到目标眼压的患者人数,卢美根组与噻吗心安组比较差异有统计学意义（P〈0.01）[合并危险比（RR）=1.87,95%CI（1.45,2.41）];2篇文献报道随访〉6个月时达到目标眼压患者人数,卢美根组与噻吗心安组比较差异有统计学意义（P〈0.01）[合并RR=1.60,95%CI（1.36,1.90）]。结膜充血及睫毛变长为拟前列腺素类抗青光眼药物2种较为常见的不良反应,其发生率卢美根组与噻吗心安组比较,差异均有统计学意义（P〈0.01）[合并RR=4.18,95%CI（2.89,6.05）、RR=9.40,95%CI（5.62,15.71）]。结论卢美根在降低眼压的程度和随访不同时期达到目标眼压的人数方面均优于噻吗心安。除结膜充血及睫毛变长的发生率卢美根组高于噻吗心安组外,2种药物均未发现有严重的药物相关不良反应。     

Efficacy and safety of bimatoprost in glaucoma and ocular hypertension in non-responder patients

AIM: To establish the efficacy and safety of bimatoprost 0.03% monotherapy in glaucoma and ocular hypertension (OHT) patients with inadequate intraocular pressure (IOP)on current therapy. METHODS: Pre- and post-switch IOPs were analyzed for 59 consecutive patients who were switched from current therapy to bimatoprost monotherapy between 2011-2015. Demographic information, diagnosis, and any adverse events were recorded. Change in IOP post-pre switch was analyzed using a 2-sided Student''s paired t-test at the 5% significance level. RESULTS: There was a statistically significant mean reduction in IOP at the first follow up visit, which was maintained at subsequent follow up visits for patients regardless of diagnosis, or pre-switch treatment (P<0.001). Subgroup analysis also demonstrated a statistically significant mean reduction in IOP when looking at OHT patients only, as well as patients with any diagnosis switched from latanoprost monotherapy to bimatoprost monotherapy (P<0.001). CONCLUSION: This is the largest independent data set which supports switching glaucoma patients with poor response to current treatment onto bimatoprost monotherapy before considering other adjuvant medical or more invasive therapy.     

The effect of latanoprost on intraocular pressure during 12 months of treatment for normal-tension glaucoma

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy of latanoprost in normal-tension glaucoma (NTG). METHODS: One-hundred and seventeen eyes of 63 NTG patients treated with 0.005% latanoprost once a day were enrolled in this study. Of these, 85 eyes of 47 patients were treated for 12 months. Mean IOPs were analyzed, and the mean IOP reductions from the untreated baseline were assessed after two weeks and after 1, 3, 6, 9, and 12 months of treatment. RESULTS: The mean untreated baseline IOP was 15.0 +/- 2.7 mmHg. After two weeks of latanoprost treatment, the mean IOP reduction from the baseline value was 2.6 +/- 0.2 mmHg (17.3%, p<0.05), and after 6 and 12 months, the reduction was 2.4 +/- 0.2 mmHg (16.0%, p<0.05) and 2.4 +/- 0.2 mmHg (16.0%, p<0.05), respectively. Patients with a baseline IOP of > or = 15 mmHg achieved significantly higher IOP reductions than those with a baseline IOP of <15 mmHg at all follow-ups (p<0.05). CONCLUSIONS: Latanoprost was found to be well tolerated and to significantly reduce IOP in NTG patients.     

Safety and efficacy of bimatoprost 0.03% versus timolol maleate 0.5%/dorzolamide 2% fixed combination

PURPOSE: To determine the efficacy and safety of bimatoprost given every evening versus the dorzolamide/timolol fixed combination (DTFC) given twice daily in open-angle glaucoma and ocular hypertensive patients. METHODS: A double-masked, three-center, prospective, randomized, crossover comparison with two 8-week treatment periods following a 4-week medicine free washout period. Diurnal curve intraocular pressures (IOPs) were taken at 08:00 (trough) and 10:00 and 16:00 hours. RESULTS: A total of 35 patients were enrolled and 32 completed all evaluations. The diurnal untreated baseline intraocular pressures was 24.8 +/- 2.4 mmHg. On the last day of treatment the mean diurnal intraocular pressures was 17.4 +/- 2.9 for bimatoprost and 18.1 +/- 2.8 mmHg for DTFC (p = 0.35). The individual time points for intraocular pressures were not statistically different between groups. Both groups statistically reduced the intraocular pressures from baseline for each time point and for the diurnal curve (p < 0.05). Regarding ocular safety and tolerability, there was more conjunctival hyperemia with bimatoprost (n = 15) than with DTFC (n = 7, p = 0.013) and more burning and stinging with DTFC (n = 12) than with bimatoprost (n = 0, p = 0.0005). Few systemic adverse events were recorded and there was no statistical difference between groups for any individual event (p > 0.05). CONCLUSIONS: This study indicates that the intraocular pressures are lowered to a statistically similar amount with DTFC compared to bimatoprost in open-angle glaucoma and ocular hypertensive patients.     

Intraocular pressure and ocular hemodynamics in patients with primary open‐angle glaucoma treated with the combination of morning dosing of bimatoprost and dorzolamide hydrochloride

Acta Ophthalmol. 2011: 89: e57–e63

Abstract.

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