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
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.
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.
Parallel
Dexamethasone
Drugsingle anterior chamber injection
Prednisolone Acetate Ophthalmic
Drugtopical administration four times a day for 28 days, followed by treatment taper
Grade of anterior chamber cells (ACC)
Grade of anterior chamber flare (ACF)
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