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Brimonidine and timolol fixed-combination therapy versus monotherapy: a 3-month randomized trial in patients with glaucoma or ocular hypertension.

Author(s): Craven ER, Walters TR, Williams R, Chou C, Cheetham JK, Schiffman R, Combigan Study Group

Affiliation(s): Glaucoma Consultants of Colorado, Littleton, CO, USA. ercraven@yahoo.com

Publication date & source: 2005-08, J Ocul Pharmacol Ther., 21(4):337-48.

Publication type: Clinical Trial; Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

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 < or = 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.

Page last updated: 2006-01-31

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