CLINICAL TRIALS Three-Month Randomized Trial of Fixed-Combination Brinzolamide, 1%, and Brimonidine, 0.2% Gregory Katz, MD; Harvey DuBiner, MD; John Samples, MD; Steven Vold, MD; Kenneth Sall, MD Importance: This study evaluates the contribution of Main Outcomes and Measures: Mean IOP at the 3-month visit at all time points (8 AM,10 AM,3 PM, and the individual components of an investigational non–- 5 PM). antagonist fixed combination of brinzolamide, 1%, and brimonidine, 0.2%. This study and its sister study pro- Results: A total of 660 patients were enrolled. Baseline vide the first randomized data showing the intraocular mean IOP values were similar among treatment groups pressure (IOP)-lowering activity and the toxicity pro- at all 4 time points. At 3 months, the mean IOP of the file of this novel topical antihypertensive fixed combi- brinzolamide-brimonidine group (16.3-19.8 mm Hg) was nation. significantly lower than that of either the brinzolamide group (19.3-20.9 mm Hg; P.002) or the brimonidine Objective: To compare IOP-lowering efficacy of fixed- group (17.9-22.5 mm Hg; P.001) across all time points. combination brinzolamide, 1%, and brimonidine, 0.2%, One of 10 serious adverse events (chest pain, brinzo- with that of its components in patients with open-angle lamide group) was judged as
JAMA Ophthalmology – American Medical Association
Published: Jun 1, 2013
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