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Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

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

NCT05191706•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

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).

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.

Locations (9)

EyePoint Investigational Site

Huntington Beach, California, United States

EyePoint Investigational Site

Palo Alto, California, United States

EyePoint Investigative Site

Boston, Massachusetts, United States

EyePoint Investigational Site

Jackson, Mississippi, United States

EyePoint Investigational Site

Omaha, Nebraska, United States

EyePoint Investigational Site

Buffalo, New York, United States

EyePoint Investigative Site

New York, New York, United States

EyePoint Investigational Site

Rochester, New York, United States

EyePoint Investigational Site

Charleston, South Carolina, United States

Key Dates

Start Date

January 4, 2022

Primary Completion Date

January 1, 2026

Completion Date

February 1, 2026

Last Updated

April 3, 2025

Enrollment

ESTIMATED participants

Conditions

Cataract

Interventions

Dexamethasone

DRUG

Prednisolone Acetate Ophthalmic

DRUG

Contacts

Ramiro Ribeiro, MD, PhD

CONTACT

833-393-7646 rribeiro@eyepointpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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