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Can a new eye drop soothe the burning dryness of ocular GVHD?

NCT ID NCT07776210

Disease control Sponsor: Regenerative Ocular Immunobiologics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether an experimental eye drop called d-MAPPS can reduce eye surface damage and ease symptoms like dryness and discomfort in adults with chronic ocular graft-versus-host disease (oGVHD), a complication of stem cell transplants. Participants will use the drops four times a day for 90 days, and researchers will compare changes in corneal staining and symptom scores against a placebo. The goal is to see if this treatment can improve both the signs and the daily burden of this painful condition.

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)
What this could lead to
If successful, this could provide a new treatment to relieve painful dry eye and improve vision-related quality of life in people with chronic ocular graft-versus-host disease.
What could go wrong
This is a small, early-stage pivotal trial with only 30 participants, so results may not apply broadly. The treatment is applied locally and may not fully reverse severe eye damage.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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 or older. * Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation. * Investigator determines the participant is medically stable and appropriate for study participation. * Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline. * UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline. * Modified Oxford Corneal Staining Score of at least 1 in at least one eye. * Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments. * Written informed consent obtained before study procedures. * Willing and able to comply with study visits, study treatment, and protocol requirements. * Background therapies stable for at least 30 days before Baseline. Exclusion Criteria: * Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment. * Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis. * Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study. * Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline. * Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease. * Participation in another investigational study within 30 days before Screening or concurrent enrollment. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular graft versus host disease OGVHD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beverly Hills Institute of Ophthalmology

    RECRUITING

    Beverly Hills, California, 90210, United States

  • Beverly Hills Optometry

    RECRUITING

    Beverly Hills, California, 90211, United States

  • BostonSight

    RECRUITING

    Boston, Massachusetts, 02494, United States

  • Eyewell, LLC.

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Regenerative Ocular Immunobiologics, LLC.

    NOT_YET_RECRUITING

    Palm Harbor, Florida, 34684, United States

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