Status:

RECRUITING

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

Lead Sponsor:

EyePoint Pharmaceuticals, Inc.

Conditions:

Cataract

Eligibility:

All Genders

Up to 3 years

Phase:

PHASE4

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 Chi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05191706

Start Date

January 4 2022

End Date

February 1 2026

Last Update

April 3 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

EyePoint Investigational Site

Huntington Beach, California, United States, 92647

2

EyePoint Investigational Site

Palo Alto, California, United States, 94303

3

EyePoint Investigative Site

Boston, Massachusetts, United States, 02118

4

EyePoint Investigational Site

Jackson, Mississippi, United States, 39216