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

The purpose of this study was to determine the effectiveness and safety of brimonidine 0.2% (Alphagan((R)), Allergan Inc., Irvine, CA) as mono-, combi nation, or replacement therapy for reducing intraocular pressure (IOP) in p atients with primary open-angle glaucoma or ocular hypertension. The study method was an open-label, comparative clinical evaluation involvi ng 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 we re 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 ev aluate adverse events and the change in IOP from visit 1 to visit 3, Patien t data were grouped according to specific drug regimen, and drug regimens w ere categorized into supergroups of mono-, combination, and replacement the rapy. 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 -2.3 3 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 "e xcellent". In conclusion, brimonidine is safe and effectively lowers IOP when used as mono-, combination, or replacement therapy as observed in a large community population.