Comparison of the ocular hypotensive efficacy of adjunctive brimonidine 0.15% or brinzolamide 1% in combination with travoprost 0.004%.

Abstract

To compare efficacies of adjunctive therapy with brimonidine 0.15% and adjunctive therapy with brinzolamide 1% in combination with travoprost 0.004%. Three-month randomized, parallel-group, double-masked, multicenter clinical trial. Patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension with intraocular pressure (IOP) > 18 mmHg on monotherapy with travoprost (N = 163). Patients were randomized to receive adjunctive therapy with twice-daily brimonidine (N = 79) or twice-daily brinzolamide (N = 84). Treatment efficacy was assessed after 1 and 3 months of combination therapy. Intraocular pressure was measured at 8 am, noon, and 4 pm at baseline (on travoprost monotherapy) and after 3 months of combination therapy. Mean diurnal IOP was defined as the average of the IOP measurements at these 3 time points. Adverse events were recorded at each visit. Difference between treatment groups in mean diurnal IOP at month 3, adjusted for difference in baseline IOP, using analysis of covariance. Mean diurnal IOPs (+/- standard error of the mean) at baseline were 21.7+/-0.33 mmHg in the brimonidine group and 21.1+/-0.29 mmHg in the brinzolamide group (P = 0.16). Mean diurnal IOPs at month 3 were 19.6+/-0.41 mmHg in the brimonidine group and 18.4+/-0.33 mm Hg in the brinzolamide group (P = 0.019). At month 3, mean diurnal IOPs, adjusted for difference in baseline IOP, were 19.3+/-0.27 in the brimonidine group and 18.6+/-0.25 in the brinzolamide group (P = 0.035). The combination of travoprost and brinzolamide was statistically significantly more efficacious than the combination of travoprost and brimonidine in lowering IOP. The clinical significance of this difference is uncertain.