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

(Apricity-A Trial)

Recruiting at 15 trial locations

Overseen By Michael Belin, MD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Epion Therapeutics

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called Epithelium-On Corneal Cross-linking for people aged 8 to 45 who have Keratoconus. The treatment uses special eye drops and light to make the cornea stronger. The goal is to see if this method is safe and effective in stopping the cornea from getting worse. Corneal cross-linking using riboflavin and ultraviolet-A light has been widely adopted and refined to treat keratoconus by increasing the biomechanical strength of the cornea.

Research Team

Michael Belin, MD

Principal Investigator

Epion Therapeutics

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with keratoconus.

Treatment Details

Participant Groups

Group I: Active Treatment Experimental Treatment 1 Intervention

Epithelium-on corneal cross-linking

Group II: Control Treatment Placebo Group 1 Intervention

Placebo and sham for epithelium-on corneal cross-linking

Who Is Running the Clinical Trial?

Epion Therapeutics

Lead Sponsor

Trials

2

Recruited

800+