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Completed

NCT Number: NCT06100952

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Schwartz Laser Eye Center, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Combination Product

Drug: Ribostat riboflavin and sodium iodide ophthalmic solution

Device: UV-3000 ultraviolet A light source

Placebo and sham treatment

Combination Product

Drug: placebo ophthalmic solution

Device: UV-3000 light source

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Epion Therapeutics

Industry

Registry information

Official study 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-B)

Acronym: Apricity-B

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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