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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

Sponsor: EyePoint Pharmaceuticals, Inc. · Participants: 60 · Started: Jan 4, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05191706

Locations in the U.S.

CaliforniaEyePoint Investigational Site, Huntington Beach
MassachusettsEyePoint Investigative Site, Boston
MississippiEyePoint Investigational Site, Jackson
NebraskaEyePoint Investigational Site, Omaha
New YorkEyePoint Investigational Site, Buffalo
EyePoint Investigative Site, New York
EyePoint Investigational Site, Rochester
South CarolinaEyePoint Investigational Site, Charleston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.