Conditions: Inflammation Pain Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 514
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

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

Arms:
arm 1: Loteprednol Etabonate Gel 0.38% administered two times daily (BID). arm 2: Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). arm 3: Loteprednol Gel 0.38% administered three times daily (TID). arm 4: Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).

Interventions: intervention 1: Loteprednol Etabonate Gel (BID) intervention 2: Loteprednol Etabonate Gel (TID) intervention 3: Vehicle (BID) intervention 4: Vehicle (TID)
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 LE gel instilled into the study eye three times per day (TID) for 14 days. intervention 3: One drop of vehicle instilled into the study eye two times per day (BID) for 14 days intervention 4: One drop of vehicle instilled into the study eye three times per day (TID) for 14 days

Protocol document: