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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-B)
Key Details
Gender
All
Age Range
8 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-11-01
Completion Date
2025-11
Last Updated
2025-02-20
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 (12)
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Catalina Eye Center
Tucson, Arizona, United States
Inland Eye Specialists
Murrieta, California, United States
University of Colorado
Aurora, Colorado, United States
Chicago Cornea Consultants
Highland Park, Illinois, United States
Claris Vision LLC Eye Health Vision Centers - Dartmouth
North Dartmouth, Massachusetts, United States
Truhlsen Eye Institute
Omaha, Nebraska, United States
Providence Eye and Laser Specialists
Charlotte, North Carolina, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Dell Laser Consultants
Austin, Texas, United States
Hoopes Vision
Draper, Utah, United States
Virginia Eye Consultants
Norfolk, Virginia, United States