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

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Inflammation

Cataract

Pain

Treatments

Drug: Vehicle Gel (BID)

Drug: Loteprednol Etabonate Gel (BID)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02208297

843

Details and patient eligibility

About

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

Full description

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Enrollment

326 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.