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CompletedPhase 3

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

Key facts

Who runs it
Epion Therapeutics
Where
Brookline, Charlottesville, Cincinnati, East Syracuse, Hoffman Estates, Houston, Miami, Philadelphia, Pittsburgh, Portland, Rowland Heights, San Francisco, and St Louis, United StatesSee the 13 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
396 people enrolled
Started
30 Oct 2023
Ended
12 Jun 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
  • Placebo and sham treatment
Record updated
25 June 2026

Who can take part

Age
8 years to 45 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Diagnosis of keratoconus

Who cannot take part

  • Contraindications or hypersensitivities to any required study medications
  • Certain concomitant ocular conditions
  • Non-keratoconic ectatic disease
  • Minimal corneal thickness < 350 microns
  • Pregnancy or breastfeeding

Where in United States

  • Boston VisionBrookline, United States
  • University of VirginiaCharlottesville, United States
  • Cincinnati Eye InstituteCincinnati, United States
  • The Eye Doctors at CNY Eye CareEast Syracuse, United States
  • Chicago Cornea ConsultantsHoffman Estates, United States
  • Baylor College of MedicineHouston, United States
  • Center for Excellence in Eye CareMiami, United States
  • Wills Eye HospitalPhiladelphia, United States
  • UPMC Vision InstitutePittsburgh, United States
  • Devers Eye InstitutePortland, United States
  • Nvision Eye Centers Rowland HeightsRowland Heights, United States
  • Goodman Eye CenterSan Francisco, United States
  • Ophthalmology AssociatesSt Louis, United States

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Active TreatmentTreatment being tested

    Epithelium-on corneal cross-linking

    Treatment: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

  • Control TreatmentPlacebo, for comparison

    Placebo and sham for epithelium-on corneal cross-linking

    Treatment: Placebo and sham treatment

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Record updated
25 June 2026