Objective: To evaluate the 24-hour efficacy and safety of the travoprost/timolol maleate fixed combination (TTFC) versus travoprost when both are dosed in the evening in primary open-angle glaucoma patients.
Methods: Prospective, double-masked, crossover, active-controlled, randomized 24-hour comparison. After a 6 week medicine-free period, patients were randomized to either TTFC or travoprost for 8 weeks and were then switched to the opposite treatment for another 8 weeks. At the end of the washout and treatment periods a 24-hour pressure curve was performed.
Results: Thirty-two patients completed the study. The TTFC group demonstrated a lower absolute intraocular pressure levels for the 24-hour curve and at all time points (P¡Ü0.047). The pressure reduction from untreated baseline was significantly different between treatments for all time points (P=0.018). The mean 24-hour pressure fluctuation was lower with TTFC (3.0 mm Hg) compared to travoprost (4.0 mm Hg, P=0.001). No statistical difference existed between the two treatment groups for any adverse event (P>0.05).
Conclusions: This study suggests that when both drugs are dosed in the evening the TTFC provides improved intraocular pressure reduction over the 24-hour curve and for each individual time point in primary open-angle glaucoma patients.
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