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Clinical Trials in the USA / NCT05191706
Recruiting Phase 4

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

NCT05191706 · tracked via the Priya Life Science USA tracker
Sponsor
EyePoint Pharmaceuticals, Inc.
Phase
Phase 4
Started
2022-01-04
Last updated
2025-04-03

Condition(s) studied

Cataract

Investigational drug(s) / intervention(s)

DexamethasonePrednisolone Acetate Ophthalmic

Dexamethasone: single anterior chamber injection

Prednisolone Acetate Ophthalmic: topical administration four times a day for 28 days, followed by treatment taper

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

Sex
ALL
Min age
Max age
3 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
EyePoint Investigational Site Huntington Beach California Recruiting
EyePoint Investigational Site Palo Alto California Active Not Recruiting
EyePoint Investigative Site Boston Massachusetts Recruiting
EyePoint Investigational Site Jackson Mississippi Recruiting
EyePoint Investigational Site Omaha Nebraska Recruiting
EyePoint Investigational Site Buffalo New York Recruiting
EyePoint Investigative Site New York New York Recruiting
EyePoint Investigational Site Rochester New York Recruiting
EyePoint Investigational Site Charleston South Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05191706 on ClinicalTrials.gov ↗ ← All trials in the USA