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New eye drop trial targets chronic dry eye in transplant survivors

NCT ID NCT06852768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Beach Eye Medical Group

    Huntington Beach, California, 92648, United States

  • Beverly Hills Institute of Ophthalmology

    Beverly Hills, California, 90210, United States

  • BostonSight

    Boston, Massachusetts, 02494, United States

  • Eyewell, LLC.

    Boston, Massachusetts, 02215, United States

  • Glenn Eye Center

    Lexington, Kentucky, 40511, United States

  • Regenerative Ocular Immunobiologics, LLC.

    Palm Harbor, Florida, 34684, United States