Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: Integrated analysis of two Phase III clinical studies
Clinical Ophthalmology Aug 07, 2019
Fong R, et al. - Researchers tested the safety and effectiveness of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) vs vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies. For this investigation, patients ≥ 18 years of age with anterior chamber (AC) cells ≥ grade 2 (6–15 cells) on day 1 following cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. The integrated intent-to-treat population involved 742 patients. The authors concluded that LE (submicron) gel 0.38% administered TID is safe and effective in treating ocular inflammation and pain after cataract surgery, with minimal risk of IOP elevation. Most AEs related to treatment were mild and occurred less often with 0.38% LE gel than with vehicles.
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