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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) (Apricity-B)
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 | 2023-11-01 |
| Completion | 2025-11 |
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