A randomized, controlled comparison of macroscopic @entity3169 in XXXX treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost.

@entity1 @entity726 @entity450 @entity2790 @entity3169
PURPOSE: To evaluate @entity3169 associated with bimatoprost 0.01% treatment in @entity1 who replace latanoprost 0.005% with bimatoprost 0.01%. METHODS: Randomized, double-masked, vehicle-controlled, multicenter study of @entity1 with @entity2790 or @entity726 whose intraocular pressure (IOP) was adequately controlled on latanoprost monotherapy. At baseline, @entity1 discontinued latanoprost and were randomized to treatment with once-daily bimatoprost 0.01% (n = 151) or vehicle (n = 71). The primary endpoint was the peak change in macroscopic @entity450 ( @entity3169 evaluated by gross visual inspection) from baseline to month 1. RESULTS: Bimatoprost 0.01% was noninferior to vehicle in the mean [standard deviation] peak change from baseline macroscopic @entity450 at month 1 (0.18 [0.46] in the bimatoprost 0.01% group vs 0.02 [0.32] in the vehicle group, P = 0.009). The between-group difference was 0.15 (95% confidence interval [CI]: 0.04, 0.26), which was within the predefined margin for noninferiority of 0.5 on a @entity450 grading scale of 0 to +3. There were no statistically significant between-group differences in the percentage of @entity1 with a >= 1-grade increase in macroscopic @entity450 from baseline. Mean IOP was decreased from baseline (-0.7 to -1.3 mm Hg) in the bimatoprost 0.01% group (P  <= 0.002) and was increased from baseline (+3.3 to +3.6 mm Hg) in the vehicle group (P < 0.001) at month 1. There were no statistically significant between-group differences in adverse events. CONCLUSIONS: Bimatoprost 0.01% was noninferior to vehicle with respect to @entity3169 in this study population. Replacement of latanoprost with bimatoprost 0.01% in @entity1 with @entity2790 or @entity726 can result in additional IOP reduction without clinically important @entity450 .
