The short-term effect of adding brimonidine 0.2% to timolol treatment in patients with open-angle glaucoma.

Brimonidine, a highly selective alpha(2)-adrenoceptor agonist, was studied to determine its ocular hypotensive effect and side effects in patients with elevated intraocular pressure (IOP) while on continuing therapy with timolol. This was a prospective, randomized, placebo-controlled study in 15 patients with primary open-angle or pseudoexfoliation glaucoma on therapy receiving timolol 0.5% twice daily, with IOP greater than or equal to 22 mm Hg in one eye. IOP measurements, blood pressure and pulse rate were assessed on 2 days at a baseline and 1, 2, 4, 6 and 8 h later. A single drop of brimonidine 0.2% or placebo was added to treatment with timolol. The reductions in IOP at all time intervals observed with brimonidine + timolol were significantly greater than those with timolol + placebo. The maximum mean net decrease in IOP was 19.23 +/- 10.60% at 4 h. Statistically significant decreases in systemic blood pressure and pulse rate without clinical symptoms were observed in the group receiving brimonidine + timolol. This study suggests that a combination of brimonidine and timolol may have potential in the treatment of glaucoma. Further clinical trials with brimonidine are indicated to assess its further role as adjunctive agent.     

Comparison of the efficacy and safety of dorzolamide 2% when added to brimonidine 0.2% or timolol maleate 0.5% in patients with primary open-angle glaucoma.

OBJECTIVE: To determine the ocular hypotensive efficacy and safety of dorzolamide when added to brimonidine or timolol in patients with uncontrolled primary open-angle glaucoma (POAG). PATIENTS AND METHODS: This is a 1-year prospective open-label clinical trial of 48 consecutive POAG patients with inadequate intraocular pressure (IOP) control while using brimonidine 0.2% (23 patients) and timolol 0.5% (25 patients), 2 times daily. Patients were assigned to receive dorzolamide 2% as adjunctive therapy, added 3 times daily to brimonidine or timolol. IOP was measured on week 2, and months 3, 6, 9, and 12. RESULTS: A significant reduction in IOP from the baseline was observed after dorzolamide use in both groups at visits during that year (P < 0.001). Overall, mean IOP reduction was 5.6 +/- 1.9 mmHg with the brimonidine-dorzolamide combination, and 6.8 +/- 1.7 mmHg with timolol-dorzolamide after 1 year of treatment; the difference was significant (P = 0.029). No statistical differences existed between the groups for adverse events (P < 0.05). CONCLUSION: The addition of dorzolamide to brimonidine or timolol has significant IOP-lowering efficacy during 1 year in patients with POAG whose IOPs were inadequately controlled with brimonidine or timolol alone. The IOP-lowering effect of the timolol-dorzolamide combination at 1 year was more pronounced than brimonidine-dorzolamide. Both combinations were well-tolerated by the patients.     

A short-term study of the additive effect of latanoprost 0.005% and brimonidine 0.2%

PURPOSE: To evaluate the short-term additive effects of latanoprost 0.005% and brimonidine 0.2%. METHODS: This study was a randomized, double-masked, cross-over study that included 32 patients (32 eyes) with primary open-angle glaucoma or exfoliation glaucoma. On baseline day, intraocular pressure (IOP) was measured at 10 AM and 11 PM. Baseline IOP values were obtained by calculating the mean values for both eyes. After this process, latanoprost 0.005% was prescribed once a day during the first 5 days at 10 PM as the first test drug. During the second 5 days, twice a day brimonidine 0.2% or a placebo, as the second test drug, was added to the latanoprost at 9 AM and 10 PM. After a 4-week washout period, latanoprost 0.005% was prescribed once a day during the first 5 days at 10 PM and during the second 5 days, the second test drug, brimonidine or a placebo, was added to latanoprost, and the two drugs were prescribed twice a day for 5 days. RESULTS: During the second 5 days, although an additional 2.53-3.10 mm Hg decrease in IOP was determined in the latanoprost+brimonidine group, there was no additional decrease in the latanoprost+placebo group. CONCLUSIONS: This study showed that brimonidine and latanoprost have an additive IOP-lowering effect in open-angle glaucoma patients in the short term.     

The efficacy and safety of latanoprost 0.005% once daily versus brimonidine 0.2% twice daily in open-angle glaucoma or ocular hypertension

PURPOSE: To evaluate the efficacy and safety of latanoprost 0.005% given topically every evening versus brimonidine 0.2% given topically twice daily in primary open-angle glaucoma or ocular hypertensive patients. METHODS: This was a multicenter, crossover, double-masked comparison. After a 28-day treatment-free period, patients with primary open-angle glaucoma or ocular hypertension were randomized for 6 weeks to brimonidine or latanoprost and then crossed over to the opposite treatment. At baseline and after each treatment period, patients underwent intraocular pressure measurements every 2 hours from 08:00 to 20:00. RESULTS: In 33 patients the mean baseline trough (08:00) was 23.2 +/- 2.1 mm Hg and the diurnal curve pressure was 19.8 +/- 2.7 mm Hg. The trough and diurnal intraocular pressures for brimonidine were 19.6 +/- 3.4 mm Hg and 17.6 +/- 2.2 mm Hg, respectively. Brimonidine statistically reduced the pressure from baseline at each time point except hours 10 and 12 (P =.14 and P =.21, respectively). For latanoprost, the trough and diurnal pressures were 16.2 +/- 2.9 mm Hg and 15.4 +/- 2.5 mm Hg, respectively, and the pressure was statistically reduced at each time point (P <.001) and for the diurnal curve (P <.001). When compared directly, the intraocular pressure level for latanoprost was lower than brimonidine for the diurnal pressure and at each time point (P <.05). One patient was discontinued early from latanoprost treatment because of eyelid swelling; also, latanoprost caused more hyperemia than brimonidine (P =.04). CONCLUSION: This study suggests latanoprost dosed daily in the evening statistically reduces intraocular pressure more during daytime and evening hours than brimonidine dosed twice daily. Brimonidine may not consistently decrease the pressure 10 and 12 hours past dosing from nontreated levels.     

Therapeutic success of latanoprost 0.005% compared to brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension.

The purpose of this study was to evaluate the success rate ofmonotherapy with latanoprost 0.005% once daily versus brimonidine 0.2% twice daily in patients with open-angle glaucoma or ocular hypertension. Patients who were prescribed latanoprost or brimonidine as monotherapy were included in this study, and their consecutive charts were retrospectively reviewed. The primary efficacy variable was success of therapy, defined as a reduction in intraocular pressure > or =3 mm Hg without an adverse event leading to discontinuation over a potential of six months of therapy. We included 157 patients in this study. In the latanoprost group, 64 of 92 (70%) were considered successes; 26 of 65 (40%) were successful with brimonidine (P < 0.001). Nine failed brimonidine therapy, and one latanoprost, because of an adverse event, and the rest failed because of inadequate intraocular pressure response. The change from baseline in intraocular pressure was significantly greater with latanoprost (mean +/- S.D., 21.6 +/- 5.1 to 17.1 +/- 3.3 mm Hg) than brimonidine (23.7 +/- 5.6 to 21.9 +/- 5.7 mm Hg) (P = 0.001). Overall, 52 (80%) brimonidine- and 41 (45%) latanoprost-treated patients required additional visit(s) to adjust therapy to further lower intraocular pressure or to assess an adverse event (P < 0.001). In conclusion, latanoprost more likely provides a successful response to therapy than brimonidine when used as monotherapy in primary open-angle glaucoma or ocular hypertensive patients.     

Comparative acute effects of brimonidine 0.2% versus dorzolamide 2% combined with beta-blockers in glaucoma

Purpose: To assess the acute intraocular hypotensive efficacy of brimonidine tartrate 0.2% (a highly selective α₂-adrenergic agonist) compared with dorzolamide 2% (a topical carbonic anhydrase inhibitor) as adjunct therapy to topical β-blockers in patients with primary open-angle glaucoma. Methods: A randomized cross-over masked study was performed. We enrolled one eye of each of 28 patients who were on different β-blocker therapy. We measured the intraocular pressure (IOP) 2 h after the β-blocker instillation; we then randomly administered one of the two drugs and we compiled an IOP diurnal curve. One month later we repeated the same procedures with the second drug. Unpaired Mann-Whitney U-test was used to compare decreases in IOP between the two drugs (P<0.05). Results: Both brimonidine 0.2% and dorzolamide 2% have good ocular hypotensive efficacy, significantly lowering IOP when compared to β-blocker therapy alone, for the whole diurnal curve. Maximum mean percent IOP decrease from baseline was 22.0±15.7% (4.0± 2.9 mmHg) for dorzolamide 2% 6 h after instillation and 35.5±16.4% (7.0±4.1 mmHg) for brimonidine 0.2% 8 h after administration of the drug. When we compared the two treatments, brimonidine 0.2% showed a higher hypotensive effect than 2% dorzolamide after 4 h (28.4±16.8% vs 17.6 ±9.3%; P=0.04) and 8 h (35.5±16.4% vs 21.6 ±10.8%; P=0.04). Conclusion: This study indicates that 0.2% brimonidine acutely associated with β-blockers is an interesting new combination treatment useful in the management of glaucoma. Received: 29 July 1999 Revised: 14 September 1999 Accepted: 29 September 1999     

Ocular comfort of combination glaucoma therapies: brimonidine 0.2%/timolol 0.5% compared with dorzolamide 2%/timolol 0.5%.

PURPOSE: Successful management of glaucoma and ocular hypertension requires patient compliance with the therapeutic regimen. Because ocular discomfort affects compliance, we compared the comfort of brimonidine 0.2%/timolol 0.5% and dorzolamide 2%/timolol 0.5%. METHODS: In this single-centre, randomized, double-masked, internally controlled/paired-eye study, 30 subjects without a significant ocular surface disease received brimonidine 0.2%/timolol 0.5% in 1 eye and dorzolamide 2%/timolol 0.5% in the fellow eye. They evaluated discomfort at 30-40 s and 5 min postinstillation. RESULTS: At 30-40 s, brimonidine 0.2%/timolol 0.5% provided significantly lower mean ocular discomfort scores than dorzolamide 2%/timolol 0.5% (P < 0.0001). This pattern persisted at 5 min but was not statistically significant. Significant differences were seen in the subjects' determination of the more comfortable treatment (P < 0.0001): brimonidine 0.2%/timolol 0.5% was rated as more comfortable than dorzolamide 2%/timolol 0.5% by 80% of subjects at 30-40 s and by 27% at 5 min. Only 10% of subjects at each time point rated dorzolamide 2%/timolol 0.5% as more comfortable. The remaining subjects reported no preference at either time point. No adverse events were reported. CONCLUSIONS: Brimonidine 0.2%/timolol 0.5% was significantly more comfortable than dorzolamide 2%/timolol 0.5% upon instillation. Patients with ocular hypertension or glaucoma may be more compliant with brimonidine 0.2%/timolol 0.5% treatment.     

Effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy for glaucoma

Purpose  

To evaluate the effects of brimonidine 0.2%-timolol 0.5% fixed-combination therapy in the treatment of patients with glaucoma.     

A pharmacoeconomic analysis to determine the relative cost-effectiveness of bimatoprost 0.03% eye drops and brimonidine 0.2% eye drops in patients of primary open-angle glaucoma/ocular hypertension

Aims: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).Statistics:Independent samples t-test was used to compare the efficacy of both drugs.Results: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.Conclusion:In spite of being costlier, bimatoprost is more efficacious and cost-effective than brimonidine.     

Brimonidine 0.2% given two or three times daily versus timolol maleate 0.5% in primary open-angle glaucoma

PURPOSE: To evaluate the efficacy and safety of brimonidine 0.2% two or three times daily versus timolol maleate 0.5% solution twice daily. METHODS: Patients with primary open-angle glaucoma were randomized by Latin square technique to one of the three treatment sequences in this crossover, prospective double-masked trial. Each treatment period consisted of 6 weeks of chronic dosing followed by a diurnal curve for the intraocular pressure measured at 08:00, 10:00, 16:00, 18:00, 20:00, 22:00, and 24:00 hours. Intraocular pressure was measured by applanation tonometry. RESULTS: Thirty patients completed this trial. The average diurnal intraocular pressures in the trial were measured for timolol maleate (17.7 +/- 2.7 mm Hg), brimonidine given three times daily (18.0 +/- 2.2 mm Hg), and brimonidine given twice daily (19.2 +/- 2.4 mm Hg). There was a statistical difference between groups (P <.005). When groups were compared by pairs, three times daily dosing with brimonidine and timolol maleate both reduced the pressure more than twice daily brimonidine at every time point past 10:00 hours and for the diurnal curve (P <.05). In contrast, three times daily brimonidine and timolol maleate were statistically similar for the diurnal pressure, and each time point, except timolol maleate, decreased the pressure more at 16:00 (P =.042). Safety was similar between groups. CONCLUSIONS: This study demonstrated that both timolol maleate twice daily and brimonidine three times daily provide a similar intraocular pressure reduction to each other. Timolol maleate twice daily and brimonidine three times daily provide a greater decrease in pressure in the late afternoon and nighttime hours, compared with brimonidine twice daily.     

Timolol 0.5%/dorzolamide 2% fixed combination versus timolol 0.5%/pilocarpine 2% fixed combination in primary open-angle glaucoma or ocular hypertensive patients

PURPOSE: To establish the efficacy and safety of timolol maleate/dorzolamide fixed combination (TDFC) versus timolol maleate/pilocarpine fixed combination (TPFC), each given twice daily, in primary open-angle glaucoma or ocular hypertensive patients. METHODS: In this prospective, multicentred, double-masked trial, 37 patients were treated twice daily with timolol for 4 weeks. They were then randomized to one of the treatment medications for 6 weeks, after which they were treated with timolol again for 2 weeks before being placed on the opposite treatment medication for 6 weeks. RESULTS: A total of 36 patients completed the trial. Their mean baseline intraocular pressure (IOP) was 22.3 +/- 3.7 mmHg. Following 6 weeks of treatment, the mean trough (08.00 hours) IOP was 18.0 +/- 2.2 mmHg for TDFC and 17.4 +/- 2.0 mmHg for TPFC (p = 0.22). The mean diurnal curve IOP was 18.1 +/- 2.2 mmHg for TDFC and 16.7 +/- 1.9 mmHg for TPFC (p = 0.0007). At the remaining time-points (10.00, 18.00 and 20.00 hours), TPFC IOPs were statistically lower than TDFC IOPs (p < 0.03). There were statistically more unsolicited reports of vision change and ocular pain associated with TPFC (p = 0.04). Six patients were discontinued early from TPFC therapy (17%) versus two from TDFC (6%) (p = 0.13). CONCLUSIONS: This study suggests that TPFC can provide at least a similar efficacious reduction in IOP as TDFC in patients with primary open-angle glaucoma or ocular hypertension.     

0.2%酒石酸溴莫尼定联合0.25%倍他洛尔的短期降眼压疗效及安全性研究

目的观察0.2%酒石酸溴莫尼定滴眼液联合应用0.25%倍他洛尔混悬液对原发性开角型青光眼及高眼压症患者3个月的降眼压疗效及安全性。设计前瞻性病例系列。研究对象原发性开角型青光眼32例(57眼),高眼压症14例(27眼)。方法给予0.2%酒石酸溴莫尼定滴眼液及0.25%倍他洛尔混悬液早晚各2次点眼,分别于用药后2、4、8、12周复查,观察用药前后的眼压及不良反应,共观察3个月。主要指标眼压、不良反应。结果用药后2~12周眼压平均降低5.71~7.38mm Hg,平均降幅为21.94%~39.01%;左右眼间降眼压效果无明显区别(P>0.05);男女性别之间降眼压效果亦无显著差异(P>0.05)。随访期间,3例患者出现不能耐受的眼部刺激症状而退出试验。7例(8.33%)出现眼分泌物增多;5例(5.95%)出现眼部刺痛;10例(11.9%)出现眼部烧灼感;7例出现口苦(8.33%);3例(3.57%)出现眉弓胀痛伴头痛;视力及前节无显著变化。结论本文的短期研究显示,0.2%酒石酸溴莫尼定滴眼液联合0.25%倍他洛尔混悬液对原发性开角型青光眼及高眼压症患者具有较好的降眼压效果,副作用少。     

Efficacy of combined administration of 0.2% brimonidine and 0.5% betaxolol in treatment of primary open angle glaucoma and ocular hypertension

OBJECTIVE:To observe the efficacy of combined use of brimonidine and betaxolol in treatment of primary open angle glaucoma (POAG) and ocular hypertension.;METHODS:A total of 54 patients (90 eyes) with POAG and ocular hypertension were randomly divided into three groups (receiving betaxolol, brimonidine and combined administration of betaxolol and brimonidine respectively). The administration was given twice daily in all groups (0.5% betaxolol, 0.2% brimonidine and 0.5% betaxolol combined with 0.2% brimonidine). The changes in intraocular pressure (IOP) were observed before, and 2, 4, 6, and 8 weeks after treatment. In addition, the adverse reactions were also recorded post-treatment.;RESULTS:The mean IOPs at all the time points after treatment were significantly reduced compared with pre-treatment levels (P < 0.05). Patients receiving brimonidine had a greater reduction in IOP compared with their counterparts in the betaxolol group but the difference was not statistically significant. The IOP decline was significantly higher in the combined therapy group than in the other two groups (P < 0.01). Few cases presented with slight discomfort, such as sensation of foreign bodies, ocular irritation, dizziness, headache, fatigue, and dryness of mouth and nose. No severe adverse reactions were noted following administration.;CONCLUSIONS:Combined use of brimonidine and betaxolol is an efficacious treatment of reducing IOP without severe side effects.     

Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma

Aim

The aim of this study is to compare the 24-hour efficacy of dorzolamide/timolol-fixed combination (DTFC) and brimonidine/timolol-fixed combination (BTFC) in primary open-angle glaucoma (POAG).

Methods

One eye each of 77 POAG patients was included in this prospective, observer-masked, crossover comparison. Following a 2-month timolol run-in period, patients had three intraocular pressure (IOP) measurements at 1000, 1200 and 1400 h while on timolol treatment. Patients showing at least a 20% IOP reduction on timolol were randomised to 3 months of therapy with DTFC or BTFC, and then were crossed over to the opposite therapy.

Results

Sixty POAG patients completed the study. The mean 24-hour IOP was significantly reduced with both the fixed combinations compared with the timolol-treated diurnal IOP (P<0.001). When the two fixed combinations were compared directly, DTFC demonstrated a lower mean 24-hour IOP level as compared with BTFC (mean difference: −0.7 mm Hg, 95% confidence interval (CI): (−1.0, −0.3), P<0.001). At two individual time points, DTFC significantly reduced IOP more than BTFC: at 1800 h (−1.0 mm Hg, 95% CI (−1.6,−0.5), P=0.001) and at 0200 (−0.9 mm Hg, 95% CI: (−1.4,−0.5), P=0.001). No significant difference existed for the other time points.

Conclusion

Both the fixed combinations significantly reduce 24-hour IOP in POAG. DTFC provided significantly better 24-hour efficacy.     

Comparison of the efficacy and safety of latanoprost 0.005% compared to brimonidine 0.2% or dorzolamide 2% when added to a topical beta-adrenergic blocker in patients with primary open-angle glaucoma or ocular hypertension.

The purpose of this study was to evaluate the ocular hypotensive efficacy and safety of latanoprost 0.005% (Xalatan, Pharmacia & Upjohn), brimonidine (Alphagan, Allergan), and dorzolamide (Trusopt, Merck Inc.) when added to a beta-blocker in patients with ocular hypertension or primary open-angle glaucoma. This was a multicenter, retrospective analysis which included all reviewed patient records in which latanoprost, brimonidine or dorzolamide were added to a beta-blocker for at least three months. Patients who were treated for less than three months, who failed therapy due to ineffectiveness of the medicine or an adverse event also were included. The study included 141 patients. Latanoprost (n = 50) showed an intraocular pressure of 16.7 +/- 3.3 mm Hg (-6.3 +/- 4.1 mm Hg, P < 0.001), brimonidine (n = 24) 17.4 +/- 4.9 mm Hg (-4.2 +/- 4.5 mm Hg, P < 0.001), and dorzolamide (n = 67) 20.1 +/- 6.1 mm Hg (-3.1 +/- 5.1 mm Hg, P < 0.001) at three months. A significant difference was observed in the absolute level of intraocular pressure (P < 0.005) and the change from baseline between groups (P < 0.005) at three months. A significant difference was observed between groups in the success rate of therapy between latanoprost (70%), brimonidine (58%) and dorzolamide (40%) (P = 0.008). No significant differences were observed between groups for rate or type of adverse events leading to discontinued therapy. This study showed that latanoprost, when added to beta-blockers, compares favorably in ocular hypotensive efficacy and is similar in safety to brimonidine and dorzolamide.     

Comparison of the safety and efficacy of dorzolamide 2% and brimonidine 0.2% in patients with glaucoma or ocular hypertension

PURPOSE: To compare the intraocular pressure (IOP) reduction between dorzolamide 2% and brimonidine 0.2% in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). METHODS: This study was a prospective, double-masked, randomized, crossover comparison of dorzolamide 2% (Trusopt) and brimonidine 0.2% (Alphagan), three times daily during two six-week study periods. The primary endpoint was mean change from baseline in trough IOP and secondary endpoints were mean change from baseline in IOP one and three hours after dosing. T-tests and a repeated-measures ANOVA were used to statistically evaluate the data. RESULTS: Of 43 patients enrolled, 41 completed the first treatment and 38 completed both treatments. Baseline IOP for dorzolamide was 24.3 mm Hg and brimonidine, 24.6 mm Hg (P = 0.9). Mean IOP reduction at trough was similar for both agents, 3.0 mm Hg (P = 0.96). Reductions at one and three hours were comparable (P = ns). Both agents were well tolerated with adverse events consistent with the package inserts. Dorzolamide was associated with more frequent stinging (P = 0.017) and burning (P < 0.001), while brimonidine was associated with more frequent dry eye (P = 0.04). CONCLUSIONS: Dorzolamide and brimonidine, as monotherapy, produced equivalent IOP-lowering efficacy at trough and at one and three hours after instillation, and both were well tolerated.     

The safety and efficacy of unoprostone 0.15% versus brimonidine 0.2%

PURPOSE: To compare the efficacy and safety of unoprostone versus brimonidine both given twice daily in ocular hypertensive or primary open-angle glaucoma subjects. METHODS: After a 1-month washout period a baseline diurnal curve was measured every 2 hours from 08:00 hours (trough) to 20:00 hours in subjects with a trough intraocular pressure (IOP) and the pressure 24 mmHg. Qualified subjects were randomized to either brimonidine or unoprostone. After 6 weeks of treatment the period 1 diurnal curve was performed. Subjects were then switched to the opposite treatment for 6 weeks and the period 2 diurnal curve was performed. RESULTS: A total of 33 subjects were included in this study. In the brimonidine-treated group the trough IOP 20.1 +/- 2.8 mmHg was reduced from baseline up to 8 hours after dosing. In the unoprostone-treated group the trough IOP was 19.5 +/- 3.0 mmHg, which was statistically equal to that of brimonidine (p = 0.21), was reduced from baseline for 12 hours after dosing. Brimonidine decreased the IOP statistically more than unoprostone at 10:00 and 12:00 hours (p < 0.0001 and p = 0.02, respectively), while unoprostone reduced the IOP more than brimonidine at 18:00 and 20:00 hours (p = 0.002 and p = 0.05, respectively). Safety levels were similar between groups, but unoprostone caused more ocular stinging than brimonidine (p = 0.008). CONCLUSION: This study suggests that twice daily brimonidine demonstrates a statistically greater peak reduction in IOP than unoprostone. However, unoprostone, but not brimonidine, decreased IOP over the complete 12-hour daytime dosing cycle.     

Fixed-combination brinzolamide 1%/brimonidine 0.2% vs monotherapy with brinzolamide or brimonidine in patients with open-angle glaucoma or ocular hypertension: results of a pooled analysis of two phase 3 studies

Purpose

To describe pooled efficacy and safety data from two phase 3 studies comparing brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) with its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.

Methods

Data were pooled from two nearly identical clinical trials comparing BBFC with its component medications, each given three times daily. The 3-month efficacy outcome was mean intraocular pressure (IOP) at 0800, 1000, 1500, and 1700 hours. Safety outcomes included adverse events (AEs), best-corrected visual acuity, examination of ocular structures, pachymetry, perimetry, and vital signs.

Results

A total of 1350 patients were enrolled and included in this analysis (BBFC, n=437; brinzolamide, n=458; brimonidine, n=455). Baseline mean IOP levels were similar among the three treatment groups. At 3 months, mean IOP of the BBFC group was significantly lower than that of either monotherapy group (P<0.0001) at all the four time points. A total of 272 patients (20.1%) experienced at least one treatment-related AE (BBFC, 24.6% brinzolamide, 18.7% brimonidine, 17.4%), the majority of which were ocular AEs. One serious AE, moderate intensity chest pain, was considered related to brinzolamide treatment and resulted in study discontinuation.

Conclusions

This analysis strengthens the conclusions drawn from the two individual phase 3 studies showing that, in patients with open-angle glaucoma or ocular hypertension, BBFC had significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine alone and a safety profile consistent with that of its individual components.