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

Last updated: February 18, 2025
Sponsor: Epion Therapeutics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Eye Disease

Vision Loss

Treatment

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Placebo and sham treatment

Clinical Study ID

NCT06100952
CXL-006-B
  • 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:
November 01, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Schwartz Laser Eye Center

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Catalina Eye Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Inland Eye Specialists

    Murrieta, California 92562
    United States

    Site Not Available

  • Batra Vision Medical Group

    San Leandro, California 94578
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Chicago Cornea Consultants

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • Claris Vision LLC Eye Health Vision Centers - Dartmouth

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Truhlsen Eye Institute

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Providence Eye and Laser Specialists

    Charlotte, North Carolina 28226
    United States

    Site Not Available

  • VRF Eye Specialty Group

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Dell Laser Consultants

    Austin, Texas 78746
    United States

    Site Not Available

  • Hoopes Vision

    Draper, Utah 84020
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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