A Phase 3 interventional study of Epi-ON corneal cross-linking (CXL) in Down Syndrome (DS), Keratoconus and Pellucid Marginal Degeneration, sponsored by Woolfson Eye Institute. Recruiting at 12 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Woolfson Eye Institute · Phase 3, Interventional, and Treatment
Among 204 studies in Down Syndrome with a site in United States — 47 open to participants now, 55 under way, 4 of them phase 3. Down Syndrome · United States.
Among the 204 studies in Down Syndrome with a site in United States, this one is the 14th largest by planned enrollment of the 130 interventional ones, is one of 10 that started in 2025, is one of 10 in phase 3, reaches primary completion later than 38 of the 54 other live ones, and was the 184th registered.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 225 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →47 of the 204 studies in Down Syndrome with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 8 Years and older · all sexes · no healthy volunteers.
The full table on the hub →204 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 10 started in 2025.
Median enrollment 40 across the 130 interventional studies, 433 across the 74 observational. Of the 139 that completed or were terminated, 42 (30%) have results posted.
47 of 204 have an industry lead sponsor. The 10 most frequent:
Woolfson Eye Institute is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Woolfson Eye Institute has 1 study filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
14 of the studies in Down Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03914625Phase 3National Cancer Institute (NCI)A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia | 2027-09-30 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07008989Boston CollegeA VIRTUAL Three-month Intervention Study of the Effects of a Smartphone Application (HippoCamera) on Memory in Teens and Young Adults With Down Syndrome | 2026-12-31 |
| NCT05196984Massachusetts Institute of TechnologyGamma Frequency Stimulation in Individuals With Down Syndrome | 2026-12-31 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
Among the 204 studies in Down Syndrome with a site in United States, from their registry updates:
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:
Participants will:
Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
7. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
8. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
9. Inability to return for required postoperative examinations. 10. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Epi-ON corneal cross-linking (CXL)
Combination Product: Epi-ON corneal cross-linking (CXL)
Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light for 20 minutes.
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes.
Primarily using measurements to assess improvement of vision.
Time frame: From enrollment to the end of treatment at 6 months.
Improvement of vision as assessed by corrected distance visual acuity (CDVA).
Change in CDVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: From enrollment to the end of treatment at 6 months.
Improvement in vision as measured by high order aberrations (HOA).
At the Sponsor-Investigator's discretion, the change in HOA from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: From enrollment until end of follow-up period at 6 months.
Improvement in vision as assessed by change in coma.
At the Sponsor-Investigator's discretion, the change in coma from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: Enrollment through the follow-up phase at 6 months.
Improved vision as assessed by Uncorrected Visual Acuity (UCVA).
Change in UCVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: Enrollment through the end of the follow-up period at 6 months.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Nov 2028, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
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Woolfson Eye Institute