Recruiting

DEXYCU

Sponsor:

EyePoint Pharmaceuticals, Inc.

Code:

NCT05191706

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Prednisolone Acetate Ophthalmic

Study Details

Brief 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

Conditions

Cataract

Study ID

NCT05191706

Start date

Jan 4, 2022

Status verified date

Apr, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DEXYCU (dexamethasoneintraocular suspension) 9%

A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.

active comparator: Prednisolone acetate ophthalmic suspension (USP) 1%

Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.

Interventions

Dexamethasone

single anterior chamber injection

Prednisolone Acetate Ophthalmic

topical administration four times a day for 28 days, followed by treatment taper

Primary outcome measure

  • Grade of anterior chamber cells (ACC) [ Time Frame: Post-Operative Day 14 ]

Central Contacts and Locations

Central contacts

Ramiro Ribeiro, MD, PhD

833-393-7646rribeiro@eyepointpharma.com

Locations

EyePoint Investigational Site

Recruiting

Huntington Beach, California, United States, 92647

EyePoint Investigative Site

Recruiting

Boston, Massachusetts, United States, 02118

EyePoint Investigational Site

Recruiting

Jackson, Mississippi, United States, 39216

EyePoint Investigational Site

Recruiting

Omaha, Nebraska, United States, 68114

EyePoint Investigational Site

Recruiting

Buffalo, New York, United States, 14209

EyePoint Investigative Site

Recruiting

New York, New York, United States, 10032

EyePoint Investigational Site

Recruiting

Rochester, New York, United States, 14642

EyePoint Investigational Site

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

EyePoint Pharmaceuticals, Inc.

Last update posted

Apr 3, 2025

Last verified

Apr, 2025

Keywords

  • pediatric
  • cataract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EyePoint Pharmaceuticals, Inc. on 2025-04-03.