Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus
NCT ID: NCT06100952
Last Updated: 2025-02-20
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
2023-11-01
2025-11-30
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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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
Countries
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Other Identifiers
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CXL-006-B
Identifier Type: -
Identifier Source: org_study_id
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