Conditions: Ocular Inflammation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: no

Brief summary:
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Detailed description:

Arms:
arm 1: Loteprednol Etabonate 0.5% arm 2: Vehicle of Ophthalmic Loteprednol Etabonate

Interventions: intervention 1: Loteprednol Etabonate intervention 2: Vehicle of Ophthalmic Loteprednol Etabonate
Intervention descriptions: intervention 1: Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. intervention 2: Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Protocol document: