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Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
Sponsor: Epion Therapeutics
Summary
A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
Official title: A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus (APRICITY-A)
Key Details
Gender
All
Age Range
8 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-10-30
Completion Date
2025-10
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source
Placebo and sham treatment
Drug: placebo ophthalmic solution Device: UV-3000 light source
Locations (13)
Nvision Eye Centers Rowland Heights
Rowland Heights, California, United States
Goodman Eye Center
San Francisco, California, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States
Boston Vision
Brookline, Massachusetts, United States
Ophthalmology Associates
St Louis, Missouri, United States
The Eye Doctors at CNY Eye Care
East Syracuse, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Devers Eye Institute
Portland, Oregon, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
UPMC Vision Institute
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States