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

Phase 3

Active, not recruiting

• Conditions: Keratoconus
• Interventions: Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment; Combination Product: Placebo and sham treatment

• Registration Number: NCT06100939
• Lead Sponsor: Epion Therapeutics

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 Keratoconus

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Study Start: 2023-10-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Diagnosis of keratoconus

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment	Epithelium-on corneal cross-linking
Control Treatment	Placebo and sham treatment	Placebo and sham for epithelium-on corneal cross-linking

Primary Outcome Measures

Name	Time	Method
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)	Baseline to 12 months	BSCDVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The score ranges from 0 to 100, with a higher score representing better visual functioning.

Secondary Outcome Measures

Name	Time	Method
Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)	Baseline to 12 months	The score on the NEI-VFQ-25 ranges from 0 to 100, with a higher score indicating greater functioning.

Trial Locations

Locations (13)

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; 🇺🇸 Saint 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