Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

Phase 3 Completed 1001 enrolled Alcon Research

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.

Timeline

Start: 2011-02
Primary completion: 2012-03
Completion: 2012-03

Outcome

Met primary endpoint

paper At 3 months, the mean IOP of the brinzolamide-brimonidine group (16.3-19.8 mm Hg) was significantly lower than that of either PMID 23579344 ↗

Publications

Katz G, Dubiner H, Samples J, Vold S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol. 2013 Jun;131(6):724-30. doi: 10.1001/jamaophthalmol.2013.188.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Brimonidine	Unknown	0.2 %	Topical
Comparator	Brinzolamide	Small molecule	1 %	Topical
Subject	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension	Unknown	—	Topical