Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05191706

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

EyePoint Investigational Site, Huntington Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

single anterior chamber injection

Prednisolone Acetate Ophthalmic

Drug

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

Primary outcomes

  1. Grade of anterior chamber cells (ACC)

    Time frame: Post-Operative Day 14

Secondary outcomes

  1. Grade of anterior chamber flare (ACF)

    Time frame: Post-Operative Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Ramiro Ribeiro, MD, PhD

CONTACT

[email protected]

833-393-7646

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.