Abstract
Abstract: :
Purpose: To evaluate the efficacy and safety of the latanoprost/timolol maleate fixed combination given once each evening versus brimonidine 0.2% and timolol maleate 0.5% solution given twice daily as concomitant therapy in primary open-angle glaucoma or ocular hypertensive patients. Methods: Qualified subjects were begun on timolol maleate 0.5% twice daily alone for one month, then randomized to either the fixed combination or brimonidine and timolol maleate concomitant therapy for six-weeks, then switched to the other treatment regimen for six weeks. The intraocular pressure was measured every two hours between 08:00 and 20:00 hours at baseline and at the end of Period I and Period II. Results: This study found in 32 subjects that the diurnal curve of the intraocular pressure on timolol maleate alone (20.9 2.8 mm Hg) decreased to 17.9 3.2 mm Hg on the fixed combination and 19.0 2.4 mm Hg on brimonidine and timolol maleate (P = 0.02) At individual time points the intraocular pressures were statistically similar between the groups at the 08:00 trough and 2 and 4 hours after dosing. However, beyond 4 hours after dosing the fixed combination demonstrated lower intraocular pressures at every two-hour time point (P < 0.04). The greatest difference was at +12 hours after dosing (2.3 mm Hg [P < 0.001]). Safety was similar between groups for both solicited and unsolicited side effects. Conclusion: This study suggests that in the afternoon and evening hours the fixed combination latanoprost/timolol maleate reduces the intraocular pressure more than brimonidine and timolol maleate given concomitantly twice daily compared to timolol maleate alone.
Keywords: 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 352 clinical (human) or epidemiologic studies: natural history • 355 clinical (human) or epidemiologic studies: risk factor assessment