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NCT06100939 Clinical Trial

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

Keratoconus Clinical Trial

— Apricity-A  

Official title:
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-A)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06100939
Other study ID # CXL-006-A
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 30, 2023
Est. completion date October 2025

Study information
Verified date January 2024
Source Epion Therapeutics
Contact Michael Belin, MD
Phone 781-281-4525
Email support@epiontx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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 and sham treatment
Drug: placebo ophthalmic solution Device: UV-3000 light source

Locations
Country Name City State
United States Boston Vision Brookline Massachusetts
United States University of Virginia Charlottesville Virginia
United States Cincinnati Eye Institute Cincinnati Ohio
United States The Eye Doctors at CNY Eye Care East Syracuse New York
United States Chicago Cornea Consultants Hoffman Estates Illinois
United States Center for Excellence in Eye Care Miami Florida
United States Dean McGee Eye Institute Oklahoma City Oklahoma
United States Devers Eye Institute Portland Oregon
United States Nvision Eye Centers Rowland Heights Rowland Heights California
United States Ophthalmology Associates Saint Louis Missouri
United States Goodman Eye Center San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Epion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
See also
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Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
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Recruiting NCT00841386 - Treatment of Keratoconus Using Collagen Cross-Linking Phase 2/Phase 3
Completed NCT00347074 - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients N/A
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Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
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Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Completed NCT02444923 - Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders N/A