Purpose: To compare the clinical effectiveness and the impact on quality of life of twice-daily brimonidine 0.2% with those of twice-daily betaxolol 0.25% in patients with glaucoma or ocular hypertension.
Methods: A prospective, double-masked, randomized, comparative, multicenter, 4-month "real-life" clinical trial involving 188 patients. Medications were instilled twice daily. Efficacy was determined through measurement of intraocular pressure; safety and tolerability were measured using reports of adverse events, a quality of life survey (Glaucoma Disability Index), heart rate, and blood pressure. Patients with an inadequate response in intraocular pressure after 1 month or those who experienced significant adverse events in the first month were switched to the alternative study arm and remained taking the alternative medication for a total of 4 months or left the study. The main outcome measure was clinical success, as determined by evaluation of the efficacy, safety, and tolerability of drug treatment, and was achieved when the investigator recommended that the patient continue the treatment after completion of the study.
Results: As initial therapy, clinical success was achieved in 74% of patients treated with brimonidine, as compared with 57% of patients treated with betaxolol (P = 0.027). The overall mean decrease in intraocular pressure from baseline was 5.9 mm Hg with brimonidine and 3.8 mm Hg with betaxolol. Both treatments were well tolerated, and there were no significant between-group differences in the incidence of adverse events or in the quality of life summary scores.
Conclusions: Twice-daily brimonidine 0.2% and betaxolol 0.25% suspension were safe and effective as first-line therapy for glaucoma and ocular hypertension. In this study, brimonidine showed clinical effectiveness superior to that of betaxolol.