Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Epion Therapeutics

Conditions:

Keratoconus

Eligibility:

All Genders

8-45 years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • Diagnosis of keratoconus

Exclusion

  • Minimal corneal thickness \< 350 microns
  • Non-keratoconic ectatic disease
  • Contraindications or hypersensitivities to any required study medications
  • Pregnancy or breastfeeding
  • Certain concomitant ocular conditions

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2025

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06100952

Start Date

November 1 2023

End Date

November 1 2025

Last Update

February 20 2025

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Schwartz Laser Eye Center

Scottsdale, Arizona, United States, 85260

2

Catalina Eye Center

Tucson, Arizona, United States, 85712

3

Inland Eye Specialists

Murrieta, California, United States, 92562

4

University of Colorado

Aurora, Colorado, United States, 80045