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

Last updated: April 1, 2025
Sponsor: EyePoint Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

Dexamethasone

Prednisolone Acetate Ophthalmic

Clinical Study ID

NCT05191706
EYP-DIP-001
  • Ages < 3
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Undergoing uncomplicated cataract surgery with or without a posterior chamberintraocular lens (IOL) implantation.

  • If a contact lens is used for correction of post-operative aphakia, it must be asilicone elastomer lens or a rigid gas permeable lens (no water content).

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal,hematological, endocrine, neurological, psychiatric, respiratory, or other medicalcondition that could increase the risk to the subject as determined by theinvestigator.

  • Has a post-traumatic cataract.

  • Presence of active or suspected viral, bacterial, or fungal disease in the studyeye.

  • Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with orwithout treatment with anti-glaucoma monotherapy.

  • Subjects who have received a periocular corticosteroid injection in the study eye inthe 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Dexamethasone
Phase: 4
Study Start date:
January 04, 2022
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • EyePoint Investigational Site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Palo Alto, California 94303
    United States

    Site Not Available

  • EyePoint Investigative Site

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Buffalo, New York 14209
    United States

    Active - Recruiting

  • EyePoint Investigative Site

    New York, New York 10032
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Rochester, New York 14642
    United States

    Active - Recruiting

  • EyePoint Investigational Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.