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Quang Nguyen, Jess Whitson, Tony Realini, Stephen Goode, Matthew McMenemy; Six-Month Results From a Phase 3 Randomized Trial of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2%. Invest. Ophthalmol. Vis. Sci. 2013;54(15):449.
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This study compared the intraocular pressure (IOP)-lowering efficacy and safety of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). This abstract focuses on safety outcomes.
This was a phase 3, double-masked, multicenter, 3-month safety and efficacy study with a 3-month safety extension. After washout, eligible patients were randomly assigned 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine 3 times daily. IOP was assessed at 8 AM, 10 AM, 3 PM, and 5 PM at 2 weeks, 6 weeks, 3 months, and 6 months. Safety assessments included adverse events (AEs), best-corrected visual acuity (BCVA), slit-lamp biomicroscopy, pachymetry, perimetry, funduscopy, and blood pressure/pulse.
A total of 690 patients were enrolled; 548 completed the 6-month visit. Interim results from the 3-month visit were presented previously. At 6 months, the BBFC group demonstrated the largest IOP reduction from baseline at all time points (20%-31%) compared with the brinzolamide group (16%-22%) and the brimonidine group (12%-25%). Of the 690 patients in the safety population, 175 (25%) experienced at least 1 treatment-related AE (BBFC, 33%; brinzolamide, 19%; brimonidine, 25%). At 6 months, the most common treatment-related AEs for BBFC were eye irritation (6.3%), eye allergy (6.3%), and conjunctivitis (5.0%), for brinzolamide they were dysgeusia (10.3%) and blurred vision (6.8%), and for brimonidine they were conjunctivitis (6.0%) and conjunctivitis allergic (4.3%). No serious AEs were related to treatment. Patients using BBFC or brimonidine experienced a slight decrease in mean blood pressure (3-6 mm Hg) and pulse rate (1 beat/minute). No relevant changes were noted in BCVA, anterior or posterior segment examination, pachymetry or perimetry.
In patients with OAG or OH, no increased topical ocular or systemic risk was identified with BBFC compared with the individual components during 6 months of dosing. Overall, the safety profile of BBFC was similar to its components and did not result in additional risk to patients compared with the known risks of the individual components.
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