Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
NCT ID: NCT05191706
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2022-01-04
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DEXYCU (dexamethasoneintraocular suspension) 9%
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
Dexamethasone
single anterior chamber injection
Prednisolone acetate ophthalmic suspension (USP) 1%
Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.
Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper
Interventions
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Dexamethasone
single anterior chamber injection
Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
3 Years
ALL
No
Sponsors
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EyePoint Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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EyePoint Investigational Site
Huntington Beach, California, United States
EyePoint Investigational Site
Palo Alto, California, United States
EyePoint Investigative Site
Boston, Massachusetts, United States
EyePoint Investigational Site
Jackson, Mississippi, United States
EyePoint Investigational Site
Omaha, Nebraska, United States
EyePoint Investigational Site
Buffalo, New York, United States
EyePoint Investigative Site
New York, New York, United States
EyePoint Investigational Site
Rochester, New York, United States
EyePoint Investigational Site
Charleston, South Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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EYP-DIP-001
Identifier Type: -
Identifier Source: org_study_id
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