Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
RecruitingPhase 4
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Who can join
Up to age 3 · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- Dexamethasone (drug)
- Prednisolone Acetate Ophthalmic (drug)
Sponsor: EyePoint Pharmaceuticals, Inc. · Participants: 60 · Started: Jan 4, 2022
Contact the study team
- Ramiro Ribeiro, MD, PhD · Phone: 833-393-7646
Official record on ClinicalTrials.gov — NCT05191706
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.