Can exosome eye drops soothe Sjögren's dry eyes?
NCT ID NCT07192666
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early trial tests whether exosome eye drops can safely relieve dry eye symptoms in people with Sjögren's syndrome. Twelve adults whose dry eyes haven't improved with standard treatments will use the drops four times daily for two weeks. The main goal is to check for side effects; researchers will also look for signs of better eye comfort and less eye damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exosome eye drops
- What this could lead to
- If it works, this could point toward a new way to ease dry eye symptoms in people with Sjögren's syndrome.
- What could go wrong
- This is a very early, small trial (12 people) focused on safety, not proof of effectiveness. The drops may not improve symptoms, and side effects are unknown.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 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 to 65 years
- 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: * Aged 18-65 years old, including the boundary value, no gender restriction; * Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement. * The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids. * Extra-ocular manifestations of Sjögren's syndrome clinically stable. * Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period. * Willing to participate in the study, understand and sign the informed consent form (ICF). Exclusion Criteria: * Known allergy to any component of the investigational drug. * Active ocular infection. * Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns. * History of any ocular surgery within the preceding 6 months, including cataract surgery. * Participation in another interventional clinical study. * Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products. * Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system. * Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug. * Subjects deemed unsuitable for participation in this trial by the investigator.
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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 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.
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