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

NCT06100939 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-05-01

No results posted yet for this study

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

Interventions

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

COMBINATION_PRODUCT

Placebo and sham treatment

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

Sponsors & Collaborators

  • Epion Therapeutics

    lead INDUSTRY

Principal Investigators

  • Michael Belin, MD · Epion Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100939 on ClinicalTrials.gov