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

January 23, 2024 updated by: Epion Therapeutics

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Schwartz Laser Eye Center
        • Contact:
          • Jay Schwartz, MD
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Catalina Eye Center
        • Contact:
          • Ovette Villavicencio, MD
    • California
      • Murrieta, California, United States, 92562
        • Recruiting
        • Inland Eye Specialists
        • Contact:
          • Duncan Johnson, MD
      • San Leandro, California, United States, 94578
        • Recruiting
        • Batra Vision Medical Group
        • Contact:
          • Nicholas Batra, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Michael Taravella, MD
    • Illinois
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • Chicago Cornea Consultants
        • Contact:
          • Rachel Epstein, MD
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • Claris Vision LLC Eye Health Vision Centers - Dartmouth
        • Contact:
          • Kenneth Kenyon, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Not yet recruiting
        • Truhlsen Eye Institute
        • Contact:
          • Brian Armstrong, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • Recruiting
        • Providence Eye and Laser Specialists
        • Contact:
          • Reza Mozayeni, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • VRF Eye Specialty Group
        • Contact:
          • Subba Gollamudi, MD
    • Texas
      • Austin, Texas, United States, 78746
        • Recruiting
        • Dell Laser Consultants
        • Contact:
          • Steven Dell, MD
    • Utah
      • Draper, Utah, United States, 84020
        • Recruiting
        • Hoopes Vision
        • Contact:
          • Majid Moshirfar, MD
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Eye Consultants
        • Contact:
          • John Sheppard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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.
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)
Time Frame: Baseline to 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Epion Therapeutics

Investigators

  • Study Director: Michael Belin, MD, Epion Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-006-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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