Efficacy and Safety of Latanoprost/timolol Maleate Fixed Combination versus Brimonidine Given Twice Daily and Latanoprost Given Each Evening

Abstract

Abstract: : Purpose: To evaluate the efficacy and safety of the latanoprost/timolol maleate fixed combination (LTFC) given once each morning versus concomitant therapy of brimonidine 0.2% given twice daily and latanoprost 0.005% given each evening in primary open-angle glaucoma or ocular hypertensive patients. Methods: A prospective, randomized, double-masked, active-controlled comparison in which qualified subjects had all glaucoma medicines discontinued for one month and then were randomized to either LTFC or brimonidine and latanoprost concomitant therapy for six-weeks. They then were switched to the other treatment regimen. The intraocular pressure (IOP) was measured at 08:00, 12:00 and 16:00 hours at baseline and at the end of Period 1 and Period 2. Results: This study found in 32 subjects that 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 mm Hg on brimonidine and latanoprost (P = 0.31). At 08:00 and 16:00 hours the IOPs were statistically similar between the groups (P > 0.05). At 12:00 hours the latanoprost and brimonidine treatment IOP was statistically lower (16.2 ± 3.2) than the LTFC (18.0 ± 2.8 mm Hg). However, the reduced pressure 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). Conclusions: This study suggests that both the LTFC dosed each morning and concomitant therapy of brimonidine twice daily and latanoprost dosed each evening provide statistically similar diurnal IOP reduction from an untreated baseline.

Keywords: drug toxicity/drug effects • intraocular pressure • clinical (human) or epidemiologic studies: tre