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

Completed · Phase 3

Conditions studied: Inflammation, Pain, Cataract

In brief

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

Key facts

Study ID

NCT02208297

Run by

Bausch & Lomb Incorporated

People needed

326

Starts

2014-09-01

Expected to finish

2015-03-01

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb Incorporated — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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