Raymond Fong1, Bruce E Silverstein1, James H Peace1, Jon I Williams1, Jason L Vittitow2. 1. From the Manhattan Eye, Ear and Throat Hospital (Fong) and Lenox Hill Hospital (Fong), New York, New York, Shasta Eye Medical Group (Silverstein), Redding, United Medical Research Institute (Peace), Inglewood, Clinical Affairs, Bausch + Lomb (Williams), Irvine, California and Clinical Affairs, Bausch + Lomb (Vittitow), Bridgewater, New Jersey, USA. 2. From the Manhattan Eye, Ear and Throat Hospital (Fong) and Lenox Hill Hospital (Fong), New York, New York, Shasta Eye Medical Group (Silverstein), Redding, United Medical Research Institute (Peace), Inglewood, Clinical Affairs, Bausch + Lomb (Williams), Irvine, California and Clinical Affairs, Bausch + Lomb (Vittitow), Bridgewater, New Jersey, USA. Electronic address: jason.vittitow@bausch.com.
Abstract
PURPOSE: To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. SETTING: Forty-five United States ophthalmology practices. DESIGN: Double-masked vehicle-controlled randomized parallel group study. METHODS:Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). RESULTS: The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort. CONCLUSION: In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.
RCT Entities:
PURPOSE: To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. SETTING: Forty-five United States ophthalmology practices. DESIGN: Double-masked vehicle-controlled randomized parallel group study. METHODS:Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). RESULTS: The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort. CONCLUSION: In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.