A comparison of the safety and efficacy of twice daily brimonidine 0.2% versus betaxolol 0.25% in subjects with elevated intraocular pressure. The Brimonidine Study Group III.

The safety and ocular hypotensive efficacy of twice-daily administration of brimonidine 0.2% solution or betaxolol 0.25% suspension were compared in subjects with open-angle glaucoma or ocular hypertension. A total of 206 adult patients were enrolled in a prospective, 3-month, multicentered, randomized, double-masked, parallel-group study. Both drugs significantly (p < 0.001) reduced peak and trough intraocular pressure (IOP) at every scheduled follow-up visit over the 3-month study. At peak, the overall mean decrease from baseline IOP was greater (p = 0.004) in the brimonidine-treated group (5.8 mm Hg) than in the betaxolol-treated group (3.8 mm Hg). At trough, the overall mean decrease from baseline (p < 0.001) was 3.9 mm Hg in the brimonidine-treated group and 3.2 mm Hg in the betaxolol-treated group. The IOP-lowering effect of brimonidine was sustained throughout the 3-month study period. Terminations from the study due to lack of efficacy included 2.9% (3/103) of patients in the brimonidine group and 4.2% (4/96) of those in the betaxolol group. The overall incidence of adverse events was similar in both treatment groups, with the only significant (p = 0.027) between-group difference being that ocular blurring was reported more often by patients receiving betaxolol suspension than by those receiving brimonidine treatment. Instillation of drug was reported to be comfortable (p = 0.036) by more brimonidine-treated patients than betaxolol-treated patients. Overall, brimonidine 0.2% solution was well-tolerated, safe and clinically and statistically more effective than betaxolol 0.25% suspension in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.