DOUBLE-MASKED, PLACEBO-CONTROLLED EVALUATION OF LOTEPREDNOL ETABONATE0.5-PERCENT FOR POSTOPERATIVE INFLAMMATION

Purpose: To compare the efficacy and safety of loteprednol etabonate 0 .5% with those of a placebo (vehicle) in controlling anterior chamber cell and flare reaction in patients having cataract surgery with intra ocular lens (IOL) implantation. Methods: This randomized, double-maske d, placebo-control, parallel-group multicenter study comprised patient s who exhibited a minimum anterior chamber inflammation (ACI) score (s um of cell and flare reaction) of 3 (0 to 9 scale) on the day after ca taract removal with posterior chamber IOL implantation. All 227 patien ts received loteprednol etabonate 0.5% or the placebo 4 times a day in the operated eye for up to 14 day after surgery. Five patients withou t valid on-treatment follow-up visits were not evaluated for efficacy. Results: By the final visit, the ACI had resolved in 64% (70/109) of patients in the lotepredonal etabonate group and 29% (33/113) of those in the placebo group (P < .001). The resolution rate and mean change from baseline of the individual components of ACI (cell and flare), as well as other signs and symptoms, was better in the loteprednol etabo nate group. Both treatments were well tolerated. Among the 53 patients who did not complete the study, 34 (29%) were placebo patients discon tinued for inadequate anti-inflammatory effect. The treatment failure rate and the time course of failures were lower in the loteprednol eta bonate group; the differences were clinically meaningful and statistic ally significant (P < .001). The patients in the lotepredonal etabonat e group had an intraocular pressure elevation of 10 mm Hg or more over the preoperative screening value. Conclusion: Loteprednol etabonate 0 .5% led to a clinically meaningful reduction in the signs and symptoms of postoperative ACI and had an acceptable safety profile when compar ed with a placebo.