Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus

Last updated: April 29, 2025
Sponsor: Epion Therapeutics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Vision Loss

Eye Disease

Treatment

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Placebo and sham treatment

Clinical Study ID

NCT06100939
CXL-006-A
  • Ages 8-45
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of keratoconus

Exclusion

Exclusion Criteria:

  • Minimal corneal thickness < 350 microns

  • Non-keratoconic ectatic disease

  • Contraindications or hypersensitivities to any required study medications

  • Pregnancy or breastfeeding

  • Certain concomitant ocular conditions

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
Phase: 3
Study Start date:
October 30, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Nvision Eye Centers Rowland Heights

    Rowland Heights, California 91748
    United States

    Site Not Available

  • Goodman Eye Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Corneal Consultants of Colorado

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Center for Excellence in Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • Chicago Cornea Consultants

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Boston Vision

    Brookline, Massachusetts 02445
    United States

    Site Not Available

  • Ophthalmology Associates

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • The Eye Doctors at CNY Eye Care

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Devers Eye Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • UPMC Vision Institute

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Utah Eye Centers

    Ogden, Utah 84403
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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