Overview

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Eligibility

Inclusion Criteria:

• Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
• If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
• Has a post-traumatic cataract.
• Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
• Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
• Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
• Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
• Other protocol-specified exclusion criteria may apply