Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate

Criteria

Inclusion Criteria:

Visit 1 (Screening Visit)

• Be willing and able to comply with all treatment and follow-up/study procedures.

• Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

• Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.

• Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

• Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.

• Have known hypersensitivity or contraindication to the study drug(s) or their components.