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: Placebo and sham treatment; Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

• Registration Number: NCT06100952
• 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: 2023-11-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-11
• Study Completion: 2025-11

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
Control Treatment	Placebo and sham treatment	Placebo and sham for epithelium-on corneal cross-linking
Active Treatment	Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment	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 (12)

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