Could stem cell eye drops finally soothe stubborn dry eyes?
NCT ID NCT05784519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether eye drops made from mesenchymal stem cells can safely relieve symptoms in 10 women aged 40-60 with dry eye disease that didn't improve with artificial tears. Participants use the drops twice daily for two weeks and are followed for three months. The study focuses on symptom scores and tear production, but because it's very small and early, results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesenchymal stem cell eye drops
- What this could lead to
- If successful, this could point toward a new treatment option for people with dry eye disease that doesn't respond to standard artificial tears.
- What could go wrong
- This is a very early, small trial with only 10 participants, so results may not apply widely. The treatment is still experimental and its safety and effectiveness are not yet proven.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Oct 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.
- Ages
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40 to 60 years
- Sex
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Female participants only
- 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.
1. Inclusion Criteria: 1. As determined by the investigator, the subject is able to understand and comply with the protocol requirements; 2. Subject or subject's legal representative (if applicable) sign and date the written informed consent or any privacy authorization document required prior to the commencement of the study process; 3. Age 40-60; 4. Female patients; 5. The subject has received artificial tear sodium hyaluronate treatment with eye drops three times a day, but the treatment has no effect for two weeks, and the clinical examination results are consistent with: * OSDI score ≥13; * Schirmer test \< 10mm/5min; * Tear break-up time \< 10s; * Fluorescein sodium staining on the ocular surface was positive. 2. Exclusion Criteria: 1. Eye exclusion criteria: * Subjects with other eye diseases such as glaucoma, cataract, uveitis, optic neuritis, etc.; * The subjects had undergone eye surgery (e.g., cataract surgery) within the last three months; * Subjects who wear contact lenses for a long time and are unwilling to remove them in the study; * The subject has received eye drops in the past 24 hours that may affect the clinical study. 2. Exclusion criteria related to infectious diseases: * The subject has fungal, bacterial or viral keratitis or conjunctivitis with evidence of infection; * The subject has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; * The subject has any identified congenital or acquired immunodeficiency (e.g., common immunodeficiency, human immunodeficiency HIV infection, organ transplantation); * The subject has active tuberculosis (TB positive); * Subjects receive any live vaccine within 30 days prior to screening. 3. Exclusion criteria for general circumstances: * The subject is allergic to the stem cell eye drops; * The subject has any unstable or uncontrolled cardiovascular, pulmonary, liver, kidney, gastrointestinal, urogenital, hematological, clotting, immunological, endocrine/metabolic, or other medical condition that the investigator deems to interfere with the study or endanger the safety of the subject; * Subjects had had any surgery requiring general anesthesia within 30 days prior to enrollment, or planned to have a larger procedure during the study period surgery; * Subjects have a history of severe neurological diseases, including stroke, multiple sclerosis, brain tumors, or neurodegenerative diseases; * The subjects had active psychosis, which the researchers thought might interfere with their compliance with the study process; * Lactating female subjects, or female subjects with positive serum pregnancy test results during the screening period, or positive urine pregnancy test results prior to study drug administration.
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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
-
Drum Tower Hospital Affiliated to Nanjing University
Nanjing, China
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Other studies related to the condition(s) this trial covers.
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