A DOUBLE-MASKED, PLACEBO-CONTROLLED EVALUATION OF 0.5-PERCENT LOTEPREDNOL ETABONATE IN THE TREATMENT OF POSTOPERATIVE INFLAMMATION

Objective: This study aimed to compare the efficacy and safety of lote prednol etabonate (LE) 0.5% to placebo (vehicle) in controlling the an terior chamber cell and flare reaction in patients undergoing cataract surgery with intraocular lens (IOL) implantation. Design: Randomized, double-masked, placebo-controlled, parallel group multicenter study. Participants: A total of 203 patients undergoing elective cataract rem oval and posterior chamber intraocular lens implantation who, on the d ay after surgery, exhibited a minimum anterior chamber inflammation sc ore (ACI, sum of cell and flare reaction) rating of 3 (0-9 scale). Int ervention: All patients received either LE 0.5% or placebo (vehicle) f our times daily in the eye that was operated on for up to 14 days afte r surgery. Main Outcome Measures: Resolution of ACI by final, on-treat ment visit was measured. Results: The proportion of patients with ACI resolved by the final visit was 56 (55%) of 102 in the LE group and 28 (28%) of 100 in the placebo group (P < 0.001). For all the individual components of ACI (cell and flare), as well as other signs and sympto ms, the resolution rate and mean change from baseline favored LE, Expa nding the efficacy criterion to include patients with mild inflammatio n at final visit, the efficacy of LE was 95 (93%) of 102 in contrast t o 65 (65%) of 100 for placebo. Among the 39 patients who did not compl ete the study, the majority were discontinued for inadequate anti-infl ammatory effect: 25 (25%) of 101 placebo patients and 5 (5%) of 102 of LE patients. The difference in the treatment failure rates, as well t he difference in the time course of failures, was both clinically mean ingful and statistically significant in favor of LE (P < 0.001). Both treatments were well-tolerated. No clinically significant elevations i n intraocular pressure (greater than or equal to 10 mmHg) were seen in the LE treatment group. One patient in the placebo treatment group me t this criterion. Conclusions: Loteprednol etabonate showed a clinical ly meaningful reduction in the signs and symptoms of postoperative ant erior chamber inflammation when compared with that of placebo and had an acceptable safety profile compared with placebo.