Loteprednol Etabonate Ophthalmic Gel 0.5% Following Cataract Surgery: Integrated Analysis of Two Clinical Studies

Introduction We aimed to evaluate the safety and efficacy of loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials. Methods Patients with anterior chamber cell (ACC) inflammation ≥ grade 2 (6–15 cells) 1 day post-surgery were randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day instilled in the study eye for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative Day 8. Safety endpoints included adverse events (AEs), changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and funduscopy findings. Gel comfort was graded by patients according to drop sensation. Results The intent-to-treat population included 813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain ( P