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

NCT06100952 | Active Not Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: CXL-006-B
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 12

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

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)

  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.

  Baseline to 12 months

Secondary Outcomes (1)

• Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)

  Baseline to 12 months

Study Arms (2)

Active Treatment

EXPERIMENTAL

Epithelium-on corneal cross-linking

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

Control Treatment

PLACEBO COMPARATOR

Placebo and sham for epithelium-on corneal cross-linking

Combination Product: Placebo and sham treatment

Interventions

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment COMBINATION_PRODUCT

Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source

Active Treatment

Placebo and sham treatment COMBINATION_PRODUCT

Drug: placebo ophthalmic solution Device: UV-3000 light source

Control Treatment

Eligibility Criteria

• Age: 8 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of keratoconus

You may not qualify if:

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

Sponsors & Collaborators

• Epion Therapeutics: lead

Study Sites (12)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Catalina Eye Center

Tucson, Arizona, 85712, United States

Location

Inland Eye Specialists

Murrieta, California, 92562, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Chicago Cornea Consultants

Highland Park, Illinois, 60035, United States

Location

Claris Vision LLC Eye Health Vision Centers - Dartmouth

North Dartmouth, Massachusetts, 02747, United States

Location

Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

Providence Eye and Laser Specialists

Charlotte, North Carolina, 28226, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Dell Laser Consultants

Austin, Texas, 78746, United States

Location

Hoopes Vision

Draper, Utah, 84020, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Michael Belin, MD

  Epion Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)