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Purpose: The aim of this study was to compare the safety and intraocular pressure (IOP)- lowering efficacy of a fixed combination of brimonidine 0.2% and timolol 0.5% (fixed brimonidine/ timolol) versus each drug used as monotherapy.

Methods: Patients with glaucoma or ocular hypertension were randomized to receive fixed brimonidine/timolol BID (n = 385), brimonidine 0.2% TID (n = 382), or timolol 0.5% BID (n = 392) in a multicenter, double-masked study. The primary outcome measure was decrease from baseline IOP.

Results: Over all follow-up measurements, the mean decrease from baseline IOP ranged from 4.9 to 7.6 mmHg with brimonidine/timolol, from 3.1 to 5.5 mmHg with brimonidine, and from 4.3 to 6.2 mmHg with timolol. Mean IOP reductions from baseline were significantly larger with fixed brimonidine/timolol than with timolol at all follow-up measurements (P ≤ 0.026); the difference was greater than 1.5 mmHg at 10 AM (peak effect for each treatment). Mean IOP reductions from baseline were significantly larger with fixed brimonidine/ timolol than with brimonidine at 8 AM, 10 AM, and 3 PM (P < 0.001); the difference was greater than 1.5 mmHg. The rate of discontinuations owing to adverse events was 3.6% in the fixed timolol/brimonidine group.

Conclusions: The fixed combination of brimonidine and timolol was well-tolerated and provided significantly better IOP control compared with either brimonidine or timolol used alone.