Trials / Active Not Recruiting
Active Not RecruitingNCT06100939
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 (APRICITY-A)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Epion Therapeutics · Industry
- Sex
- All
- Age
- 8 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment | Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source |
| COMBINATION_PRODUCT | Placebo and sham treatment | Drug: placebo ophthalmic solution Device: UV-3000 light source |
Timeline
- Start date
- 2023-10-30
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2023-10-25
- Last updated
- 2025-05-01
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06100939. Inclusion in this directory is not an endorsement.