PURPOSE: To compare the tolerance and peak intraocular pressure (IOP)-lowering efficacy of brimonidine and latanoprost as adjunctive therapy in patients with ocular hypertension or glaucoma uncontrolled on beta-blockers. DESIGN: A prospective, multicenter, double-masked, parallel-design clinical trial. PARTICIPANTS: One hundred fifteen patients with IOP inadequately controlled on topical beta-blocker monotherapy. METHODS: Patients were randomly assigned to receive brimonidine, 0.2%, twice a day or latanoprost, 0.005%, every day as adjunctive therapy for 3 months. After 1 month of adjunctive treatment, patients who failed to meet a target 15% reduction in IOP at peak drug effect were crossed over to the other study medication. The target sample size of 51/group gave a power of 0.80 to detect a difference of 1 mmHg in mean IOP lowering between groups. MAIN OUTCOME MEASURES: The primary outcome variables were reduction in IOP from baseline at peak drug effect, response rate, and quality of life as measured using the Glaucoma Disability Index. RESULTS:Mean beta-blocker-treated baseline IOP was comparable between treatment groups (approximately 21.3 mm Hg). After 1 month of adjunctive therapy, brimonidine and latanoprost provided comparable IOP lowering (4.88 mmHg [22.8%] with brimonidine and 5.01 mmHg [23.5%] with latanoprost, P = 0.798). Response rates were similar in both groups, with 44 of 54 brimonidine patients and 43 of 53 latanoprost patients achieving the minimum target 15% IOP reduction at peak drug effect at month 1 (P = 0.963). Among patients who were successful at month 1 and continued on the initial study medication, mean IOP reductions were 4.55 mmHg with brimonidine and 5.49 mmHg with latanoprost (P = 0.149) at month 3. There was no significant difference in the ability of brimonidine and latanoprost to maintain at least a 15% additional reduction in IOP for 3 months (28 of 38 patients on brimonidine vs. 30 of 36 patients on latanoprost achieved > or =15% IOP reduction at month 3; P = 0.314). Patients in the latanoprost group were more likely to report negative quality-of-life variables than patients in the brimonidine group. Significantly more latanoprost patients reported watery or teary eyes (34 of 53, 64.2% vs. 23 of 54, 42.6% with brimonidine; P = 0.025) and hands and feet that became cold easily (24 of 53, 45.3% vs. 12 of 54, 22.2% with brimonidine; P = 0.012). CONCLUSIONS: As adjunct therapy with beta-blockers, brimonidine twice daily and latanoprost every day were comparable in lowering IOP at peak effect, but brimonidine was better tolerated, with fewer reports of adverse quality-of-life effects.
RCT Entities:
PURPOSE: To compare the tolerance and peak intraocular pressure (IOP)-lowering efficacy of brimonidine and latanoprost as adjunctive therapy in patients with ocular hypertension or glaucoma uncontrolled on beta-blockers. DESIGN: A prospective, multicenter, double-masked, parallel-design clinical trial. PARTICIPANTS: One hundred fifteen patients with IOP inadequately controlled on topical beta-blocker monotherapy. METHODS:Patients were randomly assigned to receive brimonidine, 0.2%, twice a day or latanoprost, 0.005%, every day as adjunctive therapy for 3 months. After 1 month of adjunctive treatment, patients who failed to meet a target 15% reduction in IOP at peak drug effect were crossed over to the other study medication. The target sample size of 51/group gave a power of 0.80 to detect a difference of 1 mmHg in mean IOP lowering between groups. MAIN OUTCOME MEASURES: The primary outcome variables were reduction in IOP from baseline at peak drug effect, response rate, and quality of life as measured using the Glaucoma Disability Index. RESULTS: Mean beta-blocker-treated baseline IOP was comparable between treatment groups (approximately 21.3 mm Hg). After 1 month of adjunctive therapy, brimonidine and latanoprost provided comparable IOP lowering (4.88 mmHg [22.8%] with brimonidine and 5.01 mmHg [23.5%] with latanoprost, P = 0.798). Response rates were similar in both groups, with 44 of 54 brimonidinepatients and 43 of 53 latanoprostpatients achieving the minimum target 15% IOP reduction at peak drug effect at month 1 (P = 0.963). Among patients who were successful at month 1 and continued on the initial study medication, mean IOP reductions were 4.55 mmHg with brimonidine and 5.49 mmHg with latanoprost (P = 0.149) at month 3. There was no significant difference in the ability of brimonidine and latanoprost to maintain at least a 15% additional reduction in IOP for 3 months (28 of 38 patients on brimonidine vs. 30 of 36 patients on latanoprost achieved > or =15% IOP reduction at month 3; P = 0.314). Patients in the latanoprost group were more likely to report negative quality-of-life variables than patients in the brimonidine group. Significantly more latanoprostpatients reported watery or teary eyes (34 of 53, 64.2% vs. 23 of 54, 42.6% with brimonidine; P = 0.025) and hands and feet that became cold easily (24 of 53, 45.3% vs. 12 of 54, 22.2% with brimonidine; P = 0.012). CONCLUSIONS: As adjunct therapy with beta-blockers, brimonidine twice daily and latanoprost every day were comparable in lowering IOP at peak effect, but brimonidine was better tolerated, with fewer reports of adverse quality-of-life effects.