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

Epion Therapeutics398 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

398

Conditions

Keratoconus

Interventions

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatmentCOMBINATION_PRODUCT

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

Placebo and sham treatmentCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (12)

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Catalina Eye Center

Tucson, Arizona, United States

Inland Eye Specialists

Murrieta, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 12 months

Secondary Outcomes

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.

Time frame: Baseline to 12 months

Data from ClinicalTrials.gov

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