Abstract
Purpose::
To evaluate 24-hour intraocular pressure control between morning and evening dosing of travoprost/timolol maleate fixed combination in patients with open-angle glaucoma.
Methods::
The design was a prospective, randomized, double-masked, active-controlled, crossover comparison. Following a medicine free period, patients were randomized to travoprost/timolol maleate fixed combination dosed in the morning or evening. Following 8 weeks of treatment intraocular pressure was measured at 10 AM, 2 PM, 6 PM, 10 PM, 2 AM and 6 AM. Patients then were treated with the opposite dosing regimen for another 8 weeks and the 24-hour intraocular pressure curve was repeated.
Results::
In 32 completed subjects the untreated mean 24-hour intraocular pressure was 27.7 ± 3.5 mm Hg. Both dosing regimens reduced the intraocular pressure from untreated baseline at each time point and for the 24-hour intraocular pressure curve (P < 0.0001). When treatments were compared directly, evening dosing (18.4 ± 3.3 mm Hg) provided a statistically lower 24-hour curve for the absolute intraocular pressure than morning dosing (19.2 ± 3.5 mm Hg, P = 0.001) as well as for the 10 AM, 2 PM, 6 PM and 6 AM time points (P ≤ 0.03). Evening dosing provided a lower 24-hour intraocular pressure fluctuation (3.8 ± 1.6 mm Hg) compared to morning dosing (5.1 ± 1.6 mm Hg, P = 0.0002) and lower peak intraocular pressure (20.4 ± 3.8 mm Hg) compared to morning dosing (21.7 ± 3.9, P = 0.0003). Safety was similar between groups with conjunctival hyperemia being the most common adverse event (n = 7, 22%) for both regimens (P = 1.0).
Conclusions::
This study suggests that both morning and evening dosing of travoprost/timolol maleate fixed combination provide effective 24-hour intraocular pressure reduction. However, evening dosing demonstrates better quality of 24-hour intraocular pressure control.
Clinical Trial::
www.clinicaltrials.gov NCT00331240
Keywords: intraocular pressure • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials