Status:
RECRUITING
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
Cataract
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE4
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 Chi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05191706
Start Date
January 4 2022
End Date
February 1 2026
Last Update
April 3 2025
Active Locations (9)
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1
EyePoint Investigational Site
Huntington Beach, California, United States, 92647
2
EyePoint Investigational Site
Palo Alto, California, United States, 94303
3
EyePoint Investigative Site
Boston, Massachusetts, United States, 02118
4
EyePoint Investigational Site
Jackson, Mississippi, United States, 39216