The efficacy and safety of brinzolamide 1% ophthalmic suspension (Azopt (R)) as a primary therapy in patients with open-angle glaucoma or ocular hypertension

A randomized, multicenter, double-masked, prospective, parallel study was d esigned to establish the intraocular pressure (IOP)-lowering efficacy, safe ty, and tolerability of brinzolamide 1.0% (Azopt(R)) as a primary therapy c ompared with dorzolamide 2.0% (Trusopt(R)) and placebo in patients diagnose d with open-angle glaucoma (with or without a pseudoexfoliative or a pigmen tary dispersion component) or ocular hypertension. Brinzolamide 1.0%, dosed two times (b.i.d.) and three times (t.i.d.) a day, dorzolamide 2.0% (t.i.d .), and placebo (t.i.d) were administered to patients during a 3-month trea tment period. Diurnally corrected IOP reduction from baseline, including pe ak and trough times, was the primary end point. Sample sizes were chosen to establish statistical equivalence between treatments. Mean IOP changes obs erved on treatment were as follows: -3.4 mm Hg (-13.2%) to -4.1 mm Hg (-16. 7%) with brinzolamide 1.0% b.i.d.; -4.1 mm Hg (-16.6%) to -4.8 mm Hg (-19.1 %) with brinzolamide 1% t.i.d.; and -4.3 mm Hg (-16.9%) to -4.9 mm PIS (-20 .1%)with dorzolamide 2.0%. IOP reductions after administration of brinzolam ide 1.0% b.i.d. and t.i.d. were equivalent to each other and also clinicall y and statistically equivalent to those with dorzolamide 2.0% t.i.d. The in cidence of ocular discomfort (burning and stinging) upon instillation was s ignificantly higher for dorzolamide (10.7%) than brinzolamide (b.i.d. or t. i.d., 3.0% each). The most frequent nonocular event reported was taste perv ersion, which was less (3.7%) with brinzolamide 1.0% b.i.d., but brinzolami de t.i.d. was similar to dorzolamide t.i.d. (6.8% vs. 5.3%). Brinzolamide 1 .0% b.i.d., brinzolamide 1.0% t.i.d., and dorzolamide 2.0% t.i.d. equaled e ach other in IOP-lowering efficacy, and brinzolamide was significantly more comfortable than dorzolamide upon instillation. (C) 2000 by Elsevier Scien ce Inc. All rights reserved.