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

NCT ID: NCT06100952

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keratoconus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Treatment

Epithelium-on corneal cross-linking

Group Type EXPERIMENTAL

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Intervention Type COMBINATION_PRODUCT

Drug: Ribostat riboflavin and sodium iodide ophthalmic solution

Device: UV-3000 ultraviolet A light source

Control Treatment

Placebo and sham for epithelium-on corneal cross-linking

Group Type PLACEBO_COMPARATOR

Placebo and sham treatment

Intervention Type COMBINATION_PRODUCT

Drug: placebo ophthalmic solution

Device: UV-3000 light source

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Drug: Ribostat riboflavin and sodium iodide ophthalmic solution

Device: UV-3000 ultraviolet A light source

Intervention Type COMBINATION_PRODUCT

Placebo and sham treatment

Drug: placebo ophthalmic solution

Device: UV-3000 light source

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Epion Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Belin, MD

Role: STUDY_DIRECTOR

Epion Therapeutics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Site Status

Catalina Eye Center

Tucson, Arizona, United States

Site Status

Inland Eye Specialists

Murrieta, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Chicago Cornea Consultants

Highland Park, Illinois, United States

Site Status

Claris Vision LLC Eye Health Vision Centers - Dartmouth

North Dartmouth, Massachusetts, United States

Site Status

Truhlsen Eye Institute

Omaha, Nebraska, United States

Site Status

Providence Eye and Laser Specialists

Charlotte, North Carolina, United States

Site Status

VRF Eye Specialty Group

Memphis, Tennessee, United States

Site Status

Dell Laser Consultants

Austin, Texas, United States

Site Status

Hoopes Vision

Draper, Utah, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CXL-006-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Berkeley Orthokeratology Study
NCT00000123 COMPLETED PHASE3