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

Cataract Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191706
• Other study ID #: EYP-DIP-001
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: Dario Paggiarino, MD
• Phone: 617-610-3411
• Email: dpaggiarino[@]eyepointpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Dexamethasone
single anterior chamber injection
• Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper

Locations

Country	Name	City	State
United States	EyePoint Investigative Site	Boston	Massachusetts
United States	EyePoint Investigational Site	Buffalo	New York
United States	EyePoint Investigational Site	Charleston	South Carolina
United States	EyePoint Investigational Site	Huntington Beach	California
United States	EyePoint Investigational Site	Jackson	Mississippi
United States	EyePoint Investigative Site	New York	New York
United States	EyePoint Investigational Site	Omaha	Nebraska
United States	EyePoint Investigational Site	Palo Alto	California
United States	EyePoint Investigational Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of anterior chamber cells (ACC)		Post-Operative Day 14
Secondary	Grade of anterior chamber flare (ACF)		Post-Operative Day 14