New eye drop trial targets chronic dry eye in transplant survivors
NCT ID NCT06852768
First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This early-phase trial tests whether d-MAPPS eye drops can safely and effectively treat chronic ocular graft-versus-host disease (oGVHD), a painful dry eye condition that can occur after a stem cell transplant. One adult participant will use the drops or a placebo four times daily for 90 days. Researchers will track symptom changes using dry eye questionnaires and eye scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- d-MAPPS ophthalmic solution (eye drops made from a biological substance)
- What this could lead to
- If it works, this could point toward a new treatment for chronic dry eye caused by graft-versus-host disease, potentially easing symptoms like grittiness and irritation.
- What could go wrong
- This is a very early, small trial with only 1 participant, so results may not apply to others. The treatment is compared to placebo, and it may not prove effective or safe in larger studies.
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.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Age ≥ 18 years. * Willing and able to provide written informed consent. * Willing and able to comply with study assessments for the full duration of the study. * Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual. * Minimum Oxford Schema grad of ≥ 1 in at least one eye. * OSDI scored of ≥ 22. * UNC DEMS score of ≥ 3. * In good stable overall health. Exclusion Criteria: * History of Rheumatoid Arthritis, Lupus, Scleroderma. * Ocular or periocular malignancy. * Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry. * Any history of topical tacrolimus use. * Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month. * Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry. * Current use of topical steroids more than twice a day. * Corneal epithelial defect \> 1mm2. * Any history of herpetic keratitis. * Participation in another simultaneous medical research study. * Signs of current infection, including fever and current treatment with antibiotics. * All vaccination including COVID are prohibited during this study. * Signs of current infection, including fever and current treatment with antibiotics. * All vaccinations including COVID are prohibited during this study. * Intra-ocular surgery or ocular laser surgery within 3 months. * Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study. * Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
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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.
Contacts and locations
Locations
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Beach Eye Medical Group
Huntington Beach, California, 92648, United States
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Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210, United States
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BostonSight
Boston, Massachusetts, 02494, United States
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Eyewell, LLC.
Boston, Massachusetts, 02215, United States
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Glenn Eye Center
Lexington, Kentucky, 40511, United States
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Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, 34684, United States