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

February 21, 2024 updated by: EyePoint Pharmaceuticals, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • EyePoint Investigational Site
      • Palo Alto, California, United States, 94303
        • Recruiting
        • EyePoint Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • EyePoint Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • EyePoint Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • EyePoint Investigational Site
    • New York
      • Buffalo, New York, United States, 14209
        • Recruiting
        • EyePoint Investigational Site
      • New York, New York, United States, 10032
        • Recruiting
        • EyePoint Investigative Site
      • Rochester, New York, United States, 14642
        • Recruiting
        • EyePoint Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • EyePoint Investigational Site

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.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEXYCU (dexamethasoneintraocular suspension) 9%
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
Drug: Dexamethasone
single anterior chamber injection
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.
Drug: Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade of anterior chamber cells (ACC)
Time Frame: Post-Operative Day 14
Post-Operative Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade of anterior chamber flare (ACF)
Time Frame: Post-Operative Day 14
Post-Operative Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-DIP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe