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NCT05191706PHASE4Recruiting

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

EyePoint Pharmaceuticals, Inc.

Start Date

1/4/2022

Completion Date

2/1/2026

Summary

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 Criteria

Age Range: No minimum to 3 years

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

Interventions

DRUG

Dexamethasone

DRUG

Prednisolone Acetate Ophthalmic

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Conditions

Cataract

Locations

EyePoint Investigational Site

Huntington Beach, California 92647

United States

EyePoint Investigational Site

Palo Alto, California 94303

United States

EyePoint Investigative Site

Boston, Massachusetts 02118

United States

EyePoint Investigational Site

Jackson, Mississippi 39216

United States

EyePoint Investigational Site

Omaha, Nebraska 68114

United States

EyePoint Investigational Site

Buffalo, New York 14209

United States

EyePoint Investigative Site

New York, New York 10032

United States

EyePoint Investigational Site

Rochester, New York 14642

United States

EyePoint Investigational Site

Charleston, South Carolina 29425

United States