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Rajesh K. Rajpal, Raphaele Siou-Mermet, Tara Erb, Timothy L. Comstock; Clinical Efficacy Of Loteprednol Etabonate Gel 0.5% In The Treatment Of Ocular Inflammation And Pain After Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2012;53(14):6690.
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To determine the safety and efficacy of a new, non-settling gel formulation of loteprednol etabonate (LE) in the treatment of pain and inflammation following cataract surgery.
Two multicenter, randomized, double-masked studies were conducted. In each study, patients with anterior chamber cell (ACC) severity ≥Grade 2 after cataract surgery were randomized to receive LE gel 0.5% or vehicle QID for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and no (Grade 0) pain at postoperative Day 8. Safety measures included adverse events (AE), intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort).
The ITT population included 406 patients (203 per treatment group) in the first study and 407 patients (n=206 for LE gel 0.5%, n=201 for vehicle) in the second study. In the first study, 30.5% and 16.3% of patients in the LE gel and vehicle groups, respectively, had complete resolution of ACC at Day 8, whereas 72.9% and 41.9% patients, respectively, had no (Grade 0) pain at Day 8 (P<0.001 for both). In the second study, 31.1% and 13.9% of patients in the LE gel and vehicle groups, respectively, had complete resolution of ACC at Day 8, whereas 75.7% and 45.8% patients, respectively, had no pain at Day 8 (P<0.001 for both). Significant treatment differences for resolution of ACC and no pain favoring LE gel were also found at Days 15 and 18 in both studies. One patient in each treatment group in the first study and one patient in the LE gel group in the second study exhibited a transient increase in IOP ≥10 mm Hg. Tolerability analyses for discharge, dryness, itching, pain, photophobia, and tearing favored LE gel at different timepoints in both studies. More than 85% of patients in each treatment group in both studies reported no discomfort upon instillation.
LE gel 0.5% appears safe and effective in the treatment of postoperative inflammation and pain. Additional formulation changes, including a lower preservative concentration and a more physiological pH, may provide added benefit to patients.
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