Abstract
Methods: :
This study was a prospective, double-masked, crossover, active-controlled, randomized comparison. Following a 6-week washout, patients were randomized to the travoprost/timolol fixed combination or travoprost for 8 weeks. Patients were then switched to the opposite treatment for 8 weeks. At the end of the washout and treatment periods a 24-hour intraocular pressure (IOP) curve was performed.
Results: :
In total, 34 patients were enrolled of whom 32 completed. One patient was discontinued from the fixed combination because of ocular intolerance and the other from travoprost due to headaches and gastro-intestinal disturbance. The fixed combination group demonstrated a lower absolute IOP, and greater reduction from untreated baseline, than travoprost for the 24-hour curve and at each time point (P<0.047). Further, the mean 24-hour IOP fluctuation was lower with fixed combination therapy (3.0 mmHg) compared to travoprost (4.0 mmHg, P = 0.001). Additionally, the mean maximum and mean minimum IOPs were less with the fixed combination (P<0.001, for both comparisons). No statistical difference existed between the two treatment groups for any adverse event. The most common adverse event was conjunctival hyperemia which was found in 24% (n=8) of patients treated with travoprost and 15% (n = 5) for the fixed combination (P = 0.25).
Conclusions: :
This study suggests that when both drugs are dosed in the evening the travoprost/timolol fixed combination provides improved IOP reduction over the 24-hour curve and for each individual time point in primary open-angle glaucoma patients.
Clinical Trial: :
www.clinicaltrials.gov NCT00444184
Keywords: intraocular pressure • drug toxicity/drug effects • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials