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)
Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 45
Healthy Volunteers: f
View:
• Diagnosis of keratoconus
Locations
United States
Arizona
Schwartz Laser Eye Center
Scottsdale
Catalina Eye Center
Tucson
California
Inland Eye Specialists
Murrieta
Colorado
University of Colorado
Aurora
Illinois
Chicago Cornea Consultants
Highland Park
Massachusetts
Claris Vision LLC Eye Health Vision Centers - Dartmouth
North Dartmouth
North Carolina
Providence Eye and Laser Specialists
Charlotte
Nebraska
Truhlsen Eye Institute
Omaha
Tennessee
VRF Eye Specialty Group
Memphis
Texas
Dell Laser Consultants
Austin
Utah
Hoopes Vision
Draper
Virginia
Virginia Eye Consultants
Norfolk
Time Frame
Start Date: 2023-11-01
Completion Date: 2025-11
Participants
Target number of participants: 400
Treatments
Experimental: Active Treatment
Epithelium-on corneal cross-linking
Placebo_comparator: Control Treatment
Placebo and sham for epithelium-on corneal cross-linking
Related Therapeutic Areas
Sponsors
Leads: Epion Therapeutics