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NCT07135167 · ClinicalTrials.gov registry record · Phase 3
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
A Phase 3 study of Keratoconus and Down Syndrome (DS), sponsored by Woolfson Eye Institute.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 12
- Study locations
NCT07135167 is a Phase 3 study of Keratoconus and Down Syndrome (DS) that is actively recruiting participants, run by Woolfson Eye Institute. The registered enrollment target is 225 participants, below the 1,170-participant average among 21 other Keratoconus trials with a reported enrollment target (81% lower). The trial reports 12 study locations across 3 states.
The verdict
NCT07135167, a Phase 3 study of Keratoconus and Down Syndrome (DS), is actively recruiting participants, sponsored by Woolfson Eye Institute.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 12
- Study locations
Study Summary
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be 8 years of age or older and have a diagnosis of Down syndrome. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).
Conditions Studied
Interventions
- COMBINATION_PRODUCT Epi-ON corneal cross-linking (CXL)
Study Locations (12)
Georgia
- Woolfson Eye Institute - Atlanta
- Woolfson Eye Institute - Atlanta
- Woolfson Eye Institute - Canton
- Woolfson Eye Institute - Cumming
- Woolfson Eye Institute - Douglasville
- Woolfson Eye Institute - Lawrenceville
- Woolfson Eye Institute - Marietta
- Woolfson Eye Institute - Snellville
Tennessee
- Woolfson Eye Institute - Chattanooga
- Woolfson Eye Institute - Johnson City
- Woolfson Eye Institute - Knoxville
North Carolina
- Woolfson Eye Institute - Asheville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07135167
The ClinicalTrials.gov registry entry for NCT07135167 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,170-participant average among 21 other Keratoconus trials with a reported enrollment target (81% lower). The listed sponsor is Woolfson Eye Institute, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Keratoconus appearing as the primary indexed condition, and to 1 intervention - of which Epi-ON corneal cross-linking (CXL) is the first listed.
NCT07135167 reports 12 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Tennessee, North Carolina.
Frequently Asked Questions
What is clinical trial NCT07135167 about?
NCT07135167 is a clinical study titled "Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome". The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performe...
What is the current status of trial NCT07135167?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2025-08-01. Estimated completion is 2028-12-31.
What conditions does trial NCT07135167 study?
This clinical trial studies the following conditions: Keratoconus, Down Syndrome (DS), Forme Fruste Keratoconus (FFK), Pellucid Marginal Degeneration.
What interventions are being tested in trial NCT07135167?
The interventions under investigation include: Epi-ON corneal cross-linking (CXL) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07135167?
This trial is sponsored by Woolfson Eye Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07135167 being conducted?
This trial has 12 study locations across Georgia, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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