Efficacy and safety of the latanoprost/timolol maleate fixed combination vs concomitant brimonidine and latanoprost therapy

Abstract

Aims. To evaluate the efficacy and safety of latanoprost/timolol maleate fixed combination (LTFC) given once daily vs the concomitant therapy of brimonidine twice daily and latanoprost once daily in primary open-angle glaucoma or ocular hypertensive subjects. Methods. A prospective, double-masked, active-controlled comparison in which qualified subjects had all glaucoma medicines discontinued for 1 month and then were randomized to either LTFC or brimonidine and latanoprost concomitant therapy for 6 weeks. They were then switched to the other treatment regimen. The intraocular pressure (IOP) was measured at 0800, 1200, and 1600 h at baseline and at the end of Periods 1 and Period 2. Results. In 32 subjects, the diurnal curve of the untreated IOP of 26.0±3.4 decreased to 17.8±2.5 on LTFC and 17.2±2.8 mmHg on brimonidine and latanoprost (P = 0.31). At 0800 and 1600 h, the IOPs were statistically similar between the groups (P > 0.05). At 1200 h the latanoprost and brimonidine treatment IOP was statistically lower (16.2±3.2) than LTFC (18.0±2.8 mmHg). However, the reduced IOP from untreated baseline was not statistically different at each time point and for the diurnal curve for each therapy (P < 0.05). Safety was similar between groups for both solicited and unsolicited side effects (P > 0.05). Conclusion. This study suggests that LTFC and concomitant therapy of brimonidine and latanoprost provide statistically similar diurnal IOP reduction from an untreated baseline. © 2004 Nature Publishing Group All rights reserved.