Efficacy of the fixed combinations of bimatoprost or latanoprost plus timolol in patients uncontrolled with prostaglandin monotherapy : a multicenter, randomized, investigator-masked, clinical study

PURPOSE: To compare the efficacy and tolerability of a once-daily evening dose of bimatoprost/timolol fixed combination (BTFC) with that of a once-daily evening dose of latanoprost/timolol fixed combination (LTFC) in patients not controlled with prostaglandins analogues monotherapy. METHODS: A total of 82 patients on prostaglandin analogues monotherapy were enrolled in this prospective, multicenter, investigator masked, clinical study and were randomized to either BTFC (n=47) or LTFC (n=35) topical therapy once at night for 12 weeks. The primary endpoint of the study was to compare the mean daily intraocular pressure (IOP) reduction from baseline between the two treatment arms. Secondary endpoints included the mean daily IOP at 1 and 3 months compared to baseline and the percentage of patients showing a mean IOP reduction from baseline greater than or equal to 15% or 20%. RESULTS: Mean IOP at baseline was 22.7+/-2.0 and 22.1+/-2.6 mmHg in the BTFC and LTFC groups, respectively (p=0.23). Both treatments were effective in reducing the IOP from baseline. The mean IOP reduction was significantly greater in the BTFC group than in the LTFC group (-21.4% vs -13.7%, p<0.001). A higher percentage of patients in the BTFC group showed a mean IOP reduction from baseline >or=15% (72.3% vs 40.0%) and >or=20% (61.7% vs 17.1%) compared to patients in the LTFC group. CONCLUSIONS: Both BTFC and LTFC were more effective versus the monotherapy with prostaglandin analogues. BTFC demonstrated higher performance than LTFC in terms of relative IOP reduction.