Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
NCT ID: NCT06100939
Last Updated: 2025-05-01
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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ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2023-10-30
2025-10-31
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
DOUBLE
Study Groups
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Active Treatment
Epithelium-on corneal cross-linking
Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
Drug: Ribostat riboflavin and sodium iodide ophthalmic solution
Device: UV-3000 ultraviolet A light source
Control Treatment
Placebo and sham for epithelium-on corneal cross-linking
Placebo and sham treatment
Drug: placebo ophthalmic solution
Device: UV-3000 light source
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-keratoconic ectatic disease
* Contraindications or hypersensitivities to any required study medications
* Pregnancy or breastfeeding
* Certain concomitant ocular conditions
8 Years
45 Years
ALL
No
Sponsors
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Epion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Belin, MD
Role: STUDY_DIRECTOR
Epion Therapeutics
Locations
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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
Countries
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Other Identifiers
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CXL-006-A
Identifier Type: -
Identifier Source: org_study_id
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