Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Phase 3 Completed 407 enrolled Bausch & Lomb Incorporated

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Timeline

Start: 2010-02
Primary completion: 2010-09
Completion: 2010-10

Outcome

Met primary endpoint

paper 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC PMID 24136301 ↗

paper while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P < 0.001 for both). PMID 24136301 ↗

Publications

Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loteprednol Etabonate	Other / unclassified	0.5 %	Topical

Indications

No indication recorded.