The effectiveness and safety of brimonidine as mono-, combination, or replacement therapy for patients with primary open-angle glaucoma or ocular hypertension: a post hoc analysis of an open-label community trial. Glaucoma Trial Study Group.

The purpose of this study was to determine the effectiveness and safety of brimonidine 0.2% (Alphagan, Allergan Inc., Irvine, CA) as mono-, combination, or replacement therapy for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The study method was an open-label, comparative clinical evaluation involving 2335 patients. During the 2-month trial, data were collected at baseline (visit 1), month 1 (visit 2), and month 2 (visit 3). Various parameters were evaluated, including glaucoma medications (visit 1), IOP (visit 1-visit 3), and adverse events. A subset cohort of 1254 patients was selected that met specific study criteria. Data from these 1254 patients were used to evaluate adverse events and the change in IOP from visit 1 to visit 3. Patient data were grouped according to specific drug regimen, and drug regimens were categorized into supergroups of mono-, combination, and replacement therapy. The results of the study revealed that the overall mean change in IOP for 1) monotherapy (n = 240) was -5.07 mm Hg (-20.2%), 2) combination therapy (n = 554) was -4.01 mm Hg (-16.9%), 3) replacement therapy (n = 460) was -2.33 mm Hg (-9.8%), and 4) overall (n = 1254) was -3.59 mm Hg (-14.9%) (p < 0.001 for all changes). Overall, 6.0% of the subjects reported adverse events, with no hypersensitivity or unexpected systemic or ocular adverse events. Eighty-five percent (85%) of clinicians rated brimonidine as "good" to "excellent". In conclusion, brimonidine is safe and effectively lowers IOP when used as mono-, combination, or replacement therapy as observed in a large community population.