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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05191706

Enrollment

Registered

2022-01-13

Start date

2022-01-04

Completion date

2026-02-28

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

pediatric, cataract

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

Interventions

DRUGDexamethasone

single anterior chamber injection

DRUGPrednisolone Acetate Ophthalmic

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Grade of anterior chamber cells (ACC)	Post-Operative Day 14

Secondary

Measure	Time frame
Grade of anterior chamber flare (ACF)	Post-Operative Day 14

Countries

United States

Contacts

Primary ContactRamiro Ribeiro, MD, PhD

rribeiro@eyepointpharma.com833-393-7646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026