12-MONTH RESULTS OF AN ONGOING RANDOMIZED TRIAL COMPARING BRIMONIDINETARTRATE 0.2-PERCENT AND TIMOLOL 0.5-PERCENT GIVEN TWICE-DAILY IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION

Objective: To compare the long-term safety and ocular-hypotensive effi cacy of brimonidine tartrate 0.2% with timolol maleate 0.5% administer ed twice daily in patients with glaucoma or ocular hypertension. Desig n: A double-masked, parallel-group, active-controlled, multicenter cli nical trial of 12 months' duration, Participants: Four hundred eighty- three patients with glaucoma or ocular hypertension were enrolled. Of these; 463 were evaluated according to the protocol criteria (280 in t he brimonidine tartrate group and 183 in the timolol group).Interventi ons: Brimonidine tartrate 0.2% or timolol maleate 0.5% was administere d twice daily. Main Outcome Measures: The primary efficacy variable wa s intraocular pressure (IOP). Results: Brimonidine and timolol produce d significant (P < 0.001) and sustained mean reductions in IOP through out the I-year follow-up when measured at hour 0 (trough) and at hour 2 (peak), At weeks I and 2 and month 12, significantly greater mean de creases in IOP measured at peak (P less than or equal to 0.007) were o bserved in patients treated with brimonidine as compared to timolol, w hereas the mean decrease in IOP measured at trough was significantly g reater in patients treated with timolol as compared to brimonidine (P < 0.001) at all follow-up visits. Both drugs were well-tolerated. The incidence of adverse events was similar in both treatment groups, exce pt for ocular allergy, oral dryness, and conjunctival follicles, which occurred more frequently in the brimonidine group, and burning-stingi ng, which occurred more frequently in the timolol group, Patients rece iving timolol experienced significant decreases in heart rate at all f ollow-up visits. Conclusions Topically applied twice daily for 12 mont hs, brimonidine tartrate 0.2% was safe and effective in lowering IOP i n patients with glaucoma or ocular hypertension.