Conditions: Inflammation Pain Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: Loteprednol Etabonate Gel 0.38% administered two times daily (BID) arm 2: Vehicle gel administered two times daily (BID)

Interventions: intervention 1: Loteprednol Etabonate Gel (BID) intervention 2: Vehicle Gel (BID)
Intervention descriptions: intervention 1: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days intervention 2: One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Protocol document: