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NCT06100952 · ClinicalTrials.gov registry record · Phase 3
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus
A Phase 3 study of Keratoconus, sponsored by Epion Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 12
- Study locations
NCT06100952: Active Phase 3 study of Keratoconus, sponsored by Epion Therapeutics.
NCT06100952 is a Phase 3 study of Keratoconus that is active but no longer recruiting, run by Epion Therapeutics. The registered enrollment target is 400 participants, below the 1,161-participant average among 21 other Keratoconus trials with a reported enrollment target (66% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06100952, a Phase 3 study of Keratoconus, is active but no longer recruiting, sponsored by Epion Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 12
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
- COMBINATION_PRODUCT Placebo and sham treatment
Study Locations (12)
Arizona
- Schwartz Laser Eye Center - Scottsdale
- Catalina Eye Center - Tucson
California
- Inland Eye Specialists - Murrieta
Colorado
- University of Colorado - Aurora
Illinois
- Chicago Cornea Consultants - Highland Park
Massachusetts
- Claris Vision LLC Eye Health Vision Centers - Dartmouth - North Dartmouth
Nebraska
- Truhlsen Eye Institute - Omaha
North Carolina
- Providence Eye and Laser Specialists - Charlotte
Tennessee
- VRF Eye Specialty Group - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-11 |
| Phase | Phase 3 |
What the registry record for NCT06100952 still lists
NCT06100952 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,161-participant average among 21 other Keratoconus trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Keratoconus appearing as the primary indexed condition, and to 2 interventions - of which Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment is the first listed.
NCT06100952 lists 12 locations in 11 states (Arizona, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT06100952 about?
NCT06100952 is a clinical study titled "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
What is the current status of trial NCT06100952?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2023-11-01. Estimated completion is 2025-11.
What conditions does trial NCT06100952 study?
This clinical trial studies the following conditions: Keratoconus.
What interventions are being tested in trial NCT06100952?
The interventions under investigation include: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment (COMBINATION_PRODUCT), Placebo and sham treatment (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06100952?
This trial is sponsored by Epion Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100952 being conducted?
This trial has 12 study locations across Arizona, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Keratoconus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06100952's enrollment target sits among peer trials
400 6th of 21 higher than 15 of 21 other Keratoconus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
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Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
ACTIVE NOT RECRUITING · Phase 3
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COMPLETED · Phase 3
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