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Clinical Trials
September 2006

Twice-Daily 0.2% Brimonidine–0.5% Timolol Fixed-Combination Therapy vs Monotherapy With Timolol or Brimonidine in Patients With Glaucoma or Ocular HypertensionA 12-Month Randomized Trial

Author Affiliations
 

ROY W.BECKMD, PhDAuthor Affiliations: Department of Ophthalmology, University of Florida College of Medicine, Gainesville (Dr Sherwood); Glaucoma Consultants of Colorado, Littleton (Dr Craven); Allergan Inc, Irvine, Calif (Drs Chou, Schiffman, and Whitcup and Ms Batoosingh); and Clayton Eye Center, Morrow, Ga (Dr DuBiner).

Arch Ophthalmol. 2006;124(9):1230-1238. doi:10.1001/archopht.124.9.1230
Abstract

Objective  To evaluate the intraocular pressure (IOP)–lowering efficacy and safety of a fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate (fixed brimonidine-timolol) compared with the component medications.

Methods  In 2 identical, 12-month, randomized, double-masked multicenter trials, patients with ocular hypertension or glaucoma were treated with fixed brimonidine-timolol twice daily (n = 385), 0.2% brimonidine tartrate 3 times daily (n = 382), or 0.5% timolol maleate twice daily (n = 392).

Main Outcomes Measures  Mean change from baseline IOP and incidence of adverse events.

Results  The mean decrease from baseline IOP during 12-month follow-up was 4.4 to 7.6 mm Hg with fixed brimonidine-timolol, 2.7 to 5.5 mm Hg with brimonidine, and 3.9 to 6.2 mm Hg with timolol. Mean IOP reductions were significantly greater with fixed brimonidine-timolol compared with timolol at all measurements (P≤.002) and brimonidine at 8 AM, 10 AM, and 3 PM (P<.001) but not at 5 PM. The incidence of treatment-related adverse events in the fixed-combination group was lower than that in the brimonidine group (P = .006) but higher than that in the timolol group (P<.001). The rate of discontinuation for adverse events was 14.3% with the fixed combination, 30.6% with brimonidine, and 5.1% with timolol.

Conclusions  Twice-daily fixed brimonidine-timolol therapy provides sustained IOP lowering superior to monotherapy with either thrice-daily brimonidine or twice-daily timolol and is better tolerated than brimonidine but less well tolerated than timolol.

Application to Clinical Practice  Fixed brimonidine-timolol is an effective and convenient IOP-lowering therapy.

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