Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Recruiting now · Phase 4
Conditions studied: Cataract
In brief
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
Key facts
- Study ID
- NCT05191706
- Run by
- EyePoint Pharmaceuticals, Inc.
- People needed
- 60
- Starts
- 2022-01-04
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-04-03
Who can join
Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.
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).
- Other protocol-specified inclusion criteria may apply.
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.
- Other protocol-specified exclusion criteria may apply
Where it is running
- EyePoint Investigational Site — Charleston, South Carolina, United States (enrolling)
- EyePoint Investigational Site — Huntington Beach, California, United States (enrolling)
- EyePoint Investigative Site — Boston, Massachusetts, United States (enrolling)
- EyePoint Investigational Site — Jackson, Mississippi, United States (enrolling)
- EyePoint Investigational Site — Omaha, Nebraska, United States (enrolling)
- EyePoint Investigational Site — Buffalo, New York, United States (enrolling)
- EyePoint Investigative Site — New York, New York, United States (enrolling)
- EyePoint Investigational Site — Rochester, New York, United States (enrolling)
- EyePoint Investigational Site — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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