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) (Apricity-A)

NCT06100939 Phase 3 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Epion Therapeutics
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	400
Start date	2023-10-30
Completion	2025-10

Conditions

• Keratoconus

Interventions

• Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
• Placebo and sham treatment

Primary outcomes

• Best Spectacle-Corrected Distance Visual Acuity (BSCDVA) — 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.

Countries

United States