Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial.

PURPOSE: 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. METHODS: 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. RESULTS: 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%). CONCLUSION: Bimatoprost monotherapy was well tolerated and reduced IOP by an average of 30% in a large population of untreated patients.     

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.     

Short-term effects of bimatoprost in glaucoma patients from an outpatient clinic.

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

Comparative evaluation of bimatoprost monotherapy in primary chronic angle closure and primary open angle glaucoma eyes: a three-year study.

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

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   

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.     

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 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.     

Diurnal IOP control with bimatoprost versus latanoprost in exfoliative glaucoma: a crossover, observer-masked, three-centre study

AIM: To evaluate the diurnal intraocular pressure (IOP) control and safety of bimatoprost versus latanoprost in exfoliative glaucoma (XFG). METHODS: One eye of 129 consecutive patients with XFG (mean (SD) age 66.5 (8.3) years) was included in this prospective, observer-masked, three-centre, crossover comparison. After a 4-6 week medicine-free period patients were randomised to bimatoprost or latanoprost monotherapy for 3 months. Patients were then switched to the opposite treatment for another 3 months. At the end of the washout and the treatment periods diurnal IOP was measured at 0800, 1300, and 1800. RESULTS: At baseline the IOP (mean (SD)) was 28.0 (4.0), 26.9 (3.6), and 25.9 (3.6) mm Hg, at the three time points, respectively. Both treatments significantly reduced mean diurnal IOP at month 3. Mean diurnal IOP was 26.9 (3.5) mm Hg at baseline, 17.6 (3.3) mm Hg with bimatoprost, and 18.6 (3.6) mm Hg with latanoprost (p<0.0001). Furthermore, lower IOP values were obtained with bimatoprost at all time points (17.9 (3.4), 17.3 (3.3), and 17.6 (3.5) mm Hg, respectively) compared with latanoprost (18.7 (3.6), 18.5 (3.6), and 18.6 (4.1) mm Hg, respectively). The corresponding mean differences (0.8, 1.1, and 1.0 mm Hg, respectively) were all significant (p<0.001 for each comparison). Significantly more patients with XFG obtained a target diurnal IOP <17 mm Hg with bimatoprost than with latanoprost, 55/123 (45%) v 34/123 (28%); (p = 0.001), and significantly fewer patients were non-responders with bimatoprost than with latanoprost (5 v 13, p = 0.021). More patients reported at least one adverse event with bimatoprost than with latanoprost (58 v 41 at 3 months; p = 0.0003). CONCLUSION: This crossover study suggests that better diurnal IOP control is obtained with bimatoprost than with latanoprost in patients with XFG.     

Switching efficacy on intraocular pressure from latanoprost to bimatoprost in eyes with open angle glaucoma: implication to the changes of central corneal thickness

Purpose

Intraocular pressure (IOP)-lowering effects of 0.03 % bimatoprost in eyes with open angle glaucoma (OAG) was compared with that of 0.005 % latanoprost.

Methods

Thirty-one patients with OAG who had received three kinds of ocular hypotensive agents (latanoprost, beta-blocker, and topical carbonic anhydrase inhibitor) were included in this study. In these patients, bimatoprost was administered for 8 weeks after switching from latanoprost. The IOP was measured with a goldmann applanation tonometer (GAT) at the baseline, and Weeks 2, 4 and 8 after switching the treatment. The IOP at the baseline and at the end of treatment period was measured at 10:00, 12:00, and 16:00. The central corneal thickness (CCT) was measured at each visit using an ultrasonic pachymeter.

Results

At the baseline, the mean IOP was 18.8 ± 1.4 mmHg, and the CCT was 530.7 ± 29.5 μm. At Week 8 after switching treatment, bimatoprost significantly reduced the IOP by 2.0 ± 1.6 mmHg from the baseline (p < 0.001). The CCT tended to be reduced (p = 0.009; Repeated ANOVA) and Bonferroni test indicated a statistically significant decrease of the CCT at Week 8 in comparison with that at the baseline (p = 0.013).

Conclusions

Bimatoprost has an IOP-lowering effect superior to that of latanoprost in glaucoma patients after switching from latanoprost. The use of bimatoprost can decrease the CCT for a relatively short period in a linear regression fashion.     

Comparison of the rebound tonometer with the Goldmann applanation tonometer in glaucoma patients

PURPOSE: To determine the agreement between the measurement of intraocular pressure (IOP) by the rebound tonometer (RBT) and by the Goldmann applanation tonometer (GAT) and to find out the effect of central corneal thickness (CCT) values on IOP measurements in glaucoma patients. METHODS: IOP was measured with the RBT and GAT, respectively, in 61 eyes of 61 glaucoma patients. CCT was measured using an ultrasonic pachymeter after all IOP determinations had been made. The mean IOP measurement by the RBT was compared with the measurement by the GAT, by Student's t-test. Bland-Altman analysis was performed to assess the clinical agreement between the two methods. The effect of CCT on measured IOP was explored by linear regression analysis. RESULTS: The mean patient age was 56.7+/-21.1 years (range: 30-80 years). There were 32 (52.46%) women and 29 (47.54%) men in the study group. The mean IOP readings were 18.70+/-4.76 mmHg using the RBT, and 18.27+/-3.49 mmHg using the GAT. The difference was not statistically significant (mean difference 0.43+/-2.55, P=0.2). A frequency distribution of the differences demonstrated that in more than 80% of cases the IOP readings differed by <2.3 mmHg between the RBT and GAT. There was a strong correlation between the RBT and GAT readings (r=0.852, P<0.0001). The IOP measurements with the two methods were correlated with CCT (r=0.40, P=0.02 for the RBT and r=0.48, P<0.0001 for the GAT). The IOP increased 1.1 mmHg and 8 mmHg for every 100-microm increase in CCT for the GAT and RBT, respectively. CONCLUSION: The RBT slightly overestimated the IOP value by 0.43 mmHg on average when compared with the GAT. Nevertheless, the RBT readings appeared to be more affected by the various thicknesses of different corneas when compared with those obtained using the GAT.     

The efficacy of timolol in gel-forming solution after morning or evening dosing in Asian glaucomatous patients.

AIMS: The aim of this study was to determine the effectiveness of timolol gel-forming solution as a monotherapy and to compare the efficacy of timolol gel-forming solution morning instillation versus at night application in Asians with newly diagnosed open-angle glaucoma. METHODS: A retrospective, comparative, parallel group study was conducted on 78 eligible patients diagnosed with open-angle glaucoma who received topical timolol gel-forming solution either on morning (AM dosing group; 39 patients) or evening (PM dosing group; 39 patients) as monotherapy treatment. Intraocular pressure was taken at baseline, 1, 3, 6, and 12 months post-treatment. RESULTS: Mean baseline intraocular pressure (IOP) for timolol gel-forming solution in general was 22.7 +/- 6.6 mmHg with the mean IOP reduction of 5.7 +/- 5.3 mmHg (23.1% reduction). The mean IOP reduction of the AM dosing group was 7.5 +/- 5.2 mmHg (31.0% reduction) and 3.9 +/- 4.9 mmHg (15.1% reduction) in the PM dosing group (P = 0.0002). There was a statistically significant difference of IOP reductions between AM and PM dosing group at 1 month (P = 0.041), 3 months (P = 0.037) and 12 months (P = 0.015) post-treatment. Seventy-five percent (24) of good responders was in the AM group and 67.4% (31) of poor responders were patients in the PM group. CONCLUSION: Timolol gel-forming solution is effective in reducing IOP in Asian eyes. Morning dosing was more effective in lowering the IOP compared to evening dosing.     

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.     

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.     

Comparison of the effects of latanoprost and bimatoprost on intraocular pressure in chronic angle-closure glaucoma.

PURPOSE: The aim of this study was to compare the intraocular pressure (IOP)-lowering effect of latanoprost and bimatoprost as primary therapy in patients with chronic angle-closure glaucoma (CACG) after peripheral iridotomy. METHODS: Eighty-two (82) consecutive CACG patients with an IOP greater than 19 mmHg after a peripheral iridotomy were recruited. CACG was defined as chronic elevated IOP, glaucomatous optic neuropathy, and a corresponding visual field defect in eyes with occludable angle and peripheral anterior synechiae on gonioscopy. Patients were randomly assigned to two groups based on daily treatment with either latanoprost 0.005% or bimatoprost 0.03% in the evening for 12 weeks. The IOP was measured at 9 AM and 4 PM on the same day at baseline and also at 4, 8, and 12 weeks. Between-group differences in mean diurnal IOP and IOP reduction were analyzed. RESULTS: After 12 weeks of treatment, mean IOP for both the latanoprost and bimatoprost groups was significantly reduced when compared to the baseline value (21.6 +/- 1.9 to 16.4 +/- 2.5 mmHg and 22.1 +/- 2.0 to 16.9 +/- 2.4 mmHg, respectively; P < 0.001 for both). There was no significant difference in IOP reduction between the two treatment groups (P = 0.40). At 4 and 8 weeks, the IOP changes from baseline were statistically significant at both times for both drugs (all P < 0.001). CONCLUSIONS: Both latanoprost and bimatoprost significantly reduced IOP in CACG patients who were inadequately treated by laser peripheral iridotomy.     

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.     

12-week study comparing the fixed combination of brimonidine and timolol with concomitant use of the individual components in patients with glaucoma and ocular hypertension

PURPOSE: To evaluate the efficacy and safety of fixed-combination brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution dosed BID and demonstrate non-inferiority to concomitant use of brimonidine tartrate 0.2% BID and timolol 0.5% BID in glaucoma and ocular hypertension patients with intraocular pressure (IOP) uncontrolled on monotherapy. METHODS: Randomized, multicenter, double-masked, parallel-group study involving 371 patients with inadequate IOP control (IOP from 22 to 34 mmHg) after > or =3 weeks of run-in on any monotherapy. Patients were treated with fixed-combination brimonidine/timolol BID (fixed-combination group, n = 188) or concomitant brimonidine BID and timolol BID (concomitant group, n = 183). IOP was assessed pre-dose and 2 hours after morning dosing at weeks 2, 6, and 12. RESULTS: A total of 355 patients (96%) completed the study. Patient demographics, run-in monotherapy, and baseline mean IOP on monotherapy were comparable between treatment groups. During follow-up, the mean reduction from baseline IOP was significant (p < 0.001) at all time points and ranged from 4.4 to 5.3 mmHg in each group. Brimonidine/timolol fixed combination was as effective as concomitant therapy with respect to mean IOP and mean change from baseline IOP at all time points and visits. Between-group differences were < or =0.35 mmHg for mean IOP and < or 0.30 mmHg for mean change from baseline IOP; none were significant. No unexpected side effects were associated with the fixed combination. Both treatments were well tolerated with no difference in adverse events between groups. CONCLUSIONS: Brimonidine/timolol fixed-combination therapy is as safe and effective as concomitant treatment with the individual components. Its simplified dosing regimen has the potential to improve compliance.     

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.     

Assessment of the diurnal variation in central corneal thickness and intraocular pressure for patients with suspected glaucoma

OBJECTIVE: To assess whether a single daily measurement using ultrasonic pachymetry gives a representative assessment of mean central corneal thickness (CCT) in patients with suspected glaucoma and whether diurnal changes in CCT are related to diurnal variations in intraocular pressure (IOP). DESIGN: Cross-sectional study. METHOD: Central CCT and IOP were measured by a single observer in 56 eyes of 28 patients with suspected glaucoma using an ultrasonic pachymeter and a Goldmann tonometer. Four measurements were made over a 24-hour period: at 8:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM. MAIN OUTCOME MEASURES: Intraocular pressure and pachymetry. RESULTS: Mean IOP was 19.80 mmHg at 8:00 AM (95% confidence interval [CI], 18.95-20.66 mmHg), 20.38 mmHg at 12:00 PM (95% CI, 19.49-21.26 mmHg), 19.91 mmHg at 4:00 PM (95% CI, 19.99-21.83 mmHg), and 19.23 mmHg at 8:00 PM (95% CI, 18.35-20.11 mmHg). Mean CCT was 569.4 microm (95% CI, 560.2-578.7 microm), 567.6 microm (95% CI, 558.4-576.7 microm), 569.1 microm (95% CI, 559.5-578.6 microm), and 567.2 microm (95% CI, 557.9-576.4 microm) at the four respective time points. There was no significant correlation between IOP and CCT in any patient (Pearson rank correlation coefficient); nor was there any significant correlation between the mean diurnal variations of IOP and CCT. CONCLUSIONS: In this group of patients with suspected glaucoma, there was no significant variation in CCT. Therefore, a single measurement of CCT is sufficient when assessing patients with suspected glaucoma. There was no correlation between change of IOP and change of CCT.     

Efficacy and safety of the fixed combinations latanoprost/timolol versus dorzolamide/timolol in patients with elevated intraocular pressure

PURPOSE: To compare the efficacy and safety of the fixed combination of latanoprost and timolol with those of the fixed combination of dorzolamide and timolol in patients with elevated intraocular pressure (IOP). DESIGN: Three-month, randomized, parallel group, evaluator-masked, multicenter study. PARTICIPANTS: Patients with primary open-angle glaucoma or ocular hypertension with elevated IOP insufficiently responsive to monotherapy; 253 randomized: 125 to receive a fixed combination of latanoprost 0.005% and timolol 0.5% once daily, and 128 to receive a fixed combination of dorzolamide 2% and timolol 0.5% twice daily. METHODS: Visits were at screening (current ocular hypotensive therapy was discontinued), 2 weeks (if needed for an IOP-safety check), baseline (randomization), and after 1 and 3 months of therapy. Intraocular pressure was measured in triplicate at 8 am, 12 pm, and 4 pm at each study visit, and diurnal IOP was calculated as the mean value of these recordings. Adverse events were recorded at each visit. MAIN OUTCOME MEASURE: The difference between treatment groups in the change in mean diurnal IOP from baseline to month 3. RESULTS: Mean diurnal IOP levels were similar at baseline. Mean (+/- standard error of the mean) reductions in diurnal IOP from baseline to month 3 were 9.4+/-0.27 mmHg in the latanoprost/timolol fixed-combination group, versus 8.4+/-0.26 mmHg in patients receiving the dorzolamide/timolol fixed combination. The mean difference in diurnal IOP reduction between treatments was 1.00 mmHg (95% confidence interval, 0.31-1.69; P = 0.005) in favor of the latanoprost/timolol fixed combination. Both treatments generally were well tolerated. CONCLUSIONS: The fixed combination of latanoprost and timolol was slightly more effective than that of dorzolamide and timolol in reducing mean diurnal IOP, and both treatments were generally well tolerated.