Ongoing clinical assessment of the safety profile and efficacy of brimonidine compared with timolol: Year-three results

Objective: We compared the safety profile and efficacy of brimonidine 0.2% BID with those of timolol 0.5% BID over 3 years in patients with ocular hyp ertension and glaucoma. Methods: Ninety-four eligible patients from an ongoing multicenter, interve ntional, double-masked clinical trial were followed through year 3, 48 rece iving brimonidine 0.2% and 46 receiving timolol 0.5%. Study visits occurred at months 24, 27, 30, 33, and 36. The primary efficacy variable was mean r eduction from baseline intraocular pressure (IOP) at trough. Visual acuity, visual fields, and safety variables (adverse events, ocular symptoms, hear t rate, blood pressure, and laboratory test results) were monitored through out the study. Results: The 2 treatment groups were well matched, with no significant diff erences in demographic or clinical characteristics. Both drug regimens caus ed significant mean reductions from baseline IOP at trough during year 3 (P < 0.001), with no significant differences between groups at any study visi t. The overall mean reduction from baseline IOP at trough was 5.02 mm Hg wi th brimonidine and 5.57 mm Hg with timolol (P = 0.383). Brimonidine caused reductions in IOP at trough that were equivalent to those with timolol at m onths 30 and 36 (within the 95% CI). Visual fields were unchanged or improv ed in 95% of patients in both treatment groups. Both drug regimens appeared to be safe and were well tolerated. Ocular allergy occurred in 2 brimonidi ne-treated patients (4.2%). There were no statistically significant differe nces in adverse-event reports and no clinically significant effects on any ocular or systemic safety variable in either group. Conclusions: Brimonidine 0.2% BID continues to appear to be safe, well tole rated, and effective in the long-term management of ocular hypertension and glaucoma. Over 3 years, it provided sustained IOP-lowering efficacy and vi sual-field preservation equal to those with timolol 0.5% BID.