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D. Mikropoulos, A. G. P. Konstas, B. Haidich, K. S. Ntampos, W. C. Stewart; 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Compared With Travoprost When Both Are Dosed in the Evening in Primary Open-Angle Glaucoma. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1212.
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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.
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).
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.
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