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

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 (APRICITY-B)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Combination product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment; Combination product: Placebo and sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
    • Tucson, Arizona, United States, 85712
      • Catalina Eye Center
  • California
    • Murrieta, California, United States, 92562
      • Inland Eye Specialists
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Illinois
    • Highland Park, Illinois, United States, 60035
      • Chicago Cornea Consultants
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Claris Vision LLC Eye Health Vision Centers - Dartmouth
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Truhlsen Eye Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28226
      • Providence Eye and Laser Specialists
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • VRF Eye Specialty Group
  • Texas
    • Austin, Texas, United States, 78746
      • Dell Laser Consultants
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; Epithelium-on corneal cross-linking	Combination product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment; Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source
Placebo Comparator: Control Treatment; Placebo and sham for epithelium-on corneal cross-linking	Combination product: Placebo and sham treatment; Drug: placebo ophthalmic solution Device: UV-3000 light source

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Epion Therapeutics
• Investigators: Study Director: Michael Belin, MD, Epion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamin B Complex; Vitamins; Photosensitizing Agents; Riboflavin
• Other Study ID Numbers: CXL-006-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No