NCT05191706

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2022

Longer than P75 for phase_4

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

December 13, 2021

Last Update Submit

April 1, 2025

Conditions

Cataract

Keywords

pediatriccataract

Outcome Measures

Primary Outcomes (1)

  • Grade of anterior chamber cells (ACC)

    Post-Operative Day 14

Secondary Outcomes (1)

  • Grade of anterior chamber flare (ACF)

    Post-Operative Day 14

Study Arms (2)

DEXYCU (dexamethasoneintraocular suspension) 9%

EXPERIMENTAL

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

Drug: Dexamethasone

Prednisolone acetate ophthalmic suspension (USP) 1%

ACTIVE COMPARATOR

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

Interventions

DexamethasoneDRUG

single anterior chamber injection

DEXYCU (dexamethasoneintraocular suspension) 9%
Prednisolone Acetate OphthalmicDRUG

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

Prednisolone acetate ophthalmic suspension (USP) 1%

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

EyePoint Investigational Site

Huntington Beach, California, 92647, United States

RECRUITING

EyePoint Investigational Site

Palo Alto, California, 94303, United States

ACTIVE NOT RECRUITING

EyePoint Investigative Site

Boston, Massachusetts, 02118, United States

RECRUITING

EyePoint Investigational Site

Jackson, Mississippi, 39216, United States

RECRUITING

EyePoint Investigational Site

Omaha, Nebraska, 68114, United States

RECRUITING

EyePoint Investigational Site

Buffalo, New York, 14209, United States

RECRUITING

EyePoint Investigative Site

New York, New York, 10032, United States

RECRUITING

EyePoint Investigational Site

Rochester, New York, 14642, United States

RECRUITING

EyePoint Investigational Site

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Ramiro Ribeiro, MD, PhD

CONTACT

833-393-7646rribeiro@eyepointpharma.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 13, 2022

Study Start

January 4, 2022

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)