Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Recruiting
Phase 3
Interventional Study
Down Syndrome (DS)
Keratoconus
Pellucid Marginal Degeneration
Forme Fruste Keratoconus (FFK)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 8 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 225 (estimated)
- Sponsor
- Woolfson Eye Institute · Other
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About This Trial
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) li…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Be at least 8 years of age or older, male or female, of any race.
2. Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedur…
Contacts