Why Won't dry eye heal? scientists check nerve damage in GVHD patients
NCT ID NCT04700657
First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This study explores whether nerve damage in the cornea causes stubborn dry eye in people with ocular graft-versus-host disease (GVHD), a complication of stem cell transplants. Researchers will measure corneal sensation in 30 GVHD patients and compare it to healthy controls. The goal is to understand why symptoms persist and how nerve health relates to other signs of dry eye.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If this study finds a link between corneal nerve damage and stubborn dry eye in GVHD, it could point toward new ways to treat or manage this condition.
- What could go wrong
- This is a small, early observational study with only 30 participants, so results may not apply to everyone. It is designed to gather knowledge, not test a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
30 eyes from 15 patients affected by ocular GVHD, and 30 healthy control eyes from 15 age-matched normal volunteers.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Chronic GVHD is diagnosed based on the history of allogeneic HSCT (Hematopoietic stem cell transplant) and the presence of systemic GVHD in organs other than the eye. In the ocular GVHD group, dry eye symptoms start after the development of systemic GVHD. If post-HSCT dry eye precedes GVHD clinical signs in other organs, the investigators will use the 2013 diagnostic criteria by International chronic ocular GVHD consensus group. * The investigators will recruit patients for the study. The investigators plan to include ocular GVHD patients that are of age 18 years or older who have typical symptoms of dry eye with an Ocular Surface Disease Index (OSDI) score greater than 13 and corneal fluorescein staining (CFS) score of 3 or more (National Eye Institute \[NEI\] grading scale, 0-15). Normal age-matched volunteer group will include people whose OSDI less or equal to 13 and CFS score less than 3. The patients will continue their current systemic and ocular medications, which may include one or combination of preservative free artificial tears, restasis or xiidra, serum tears, ointment, or scleral contact lens. Exclusion Criteria: * patients with a history of herpetic simplex or zoster keratitis, ocular or neurologic surgery (including laser or refractive surgical procedure) within 3 months before enrollment, trauma, diabetes with signs of peripheral neuropathy. * patients with active corneal thinning or infection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Glick Eye Institute - Indiana University
RECRUITINGIndianapolis, Indiana, 46202, United States