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

Description

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

Conditions

Cataract

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
Cataract
Intervention / Treatment

-

Contacts and Locations

Huntington Beach

EyePoint Investigational Site, Huntington Beach, California, United States, 92647

Palo Alto

EyePoint Investigational Site, Palo Alto, California, United States, 94303

Boston

EyePoint Investigative Site, Boston, Massachusetts, United States, 02118

Jackson

EyePoint Investigational Site, Jackson, Mississippi, United States, 39216

Omaha

EyePoint Investigational Site, Omaha, Nebraska, United States, 68114

Buffalo

EyePoint Investigational Site, Buffalo, New York, United States, 14209

New York

EyePoint Investigative Site, New York, New York, United States, 10032

Rochester

EyePoint Investigational Site, Rochester, New York, United States, 14642

Charleston

EyePoint Investigational Site, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

to 3 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EyePoint Pharmaceuticals, Inc.,

Study Record Dates

2025-02