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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: Recruiting Phase 3 study of Keratoconus and Down Syndrome (DS), sponsored by Woolfson Eye Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Primarily using measurements to assess improvement of vision.
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 |
What NCT07135167 shows while recruiting
NCT07135167 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,170-participant average among 21 other Keratoconus trials with a reported enrollment target (81% lower).
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 lists 12 locations in 3 states (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.
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 NCT07135167's enrollment target sits among peer trials
225 12th of 21 higher than 10 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
-
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
RECRUITING · Phase 3
-
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus
ACTIVE NOT RECRUITING · Phase 3
-
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
ACTIVE NOT RECRUITING · Phase 3
-
Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
COMPLETED · Phase 3
-
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
RECRUITING
-
OCT in Diagnosis of Irregular Corneas
RECRUITING
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