Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease
NCT ID: NCT07298811
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2025-10-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Transplant group
Transplant operation to dry eye patients
Ocular surface microbiota transplantation
Ocular surface microbiota transplantation
Placebo group
Fake transplantation to dry eye patients
Placebo Group
Fake transplant operation
Interventions
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Ocular surface microbiota transplantation
Ocular surface microbiota transplantation
Placebo Group
Fake transplant operation
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 70 years, male or female.
* Meets the diagnostic criteria for moderate to severe mixed dry eye according to the Expert Consensus on Dry Eye (2020), including:
* At least one subjective symptom (e.g., dryness, foreign body sensation, burning, fatigue, discomfort, redness, or vision fluctuation).
* Fluorescein tear film break-up time (FBUT) ≤ 5 seconds.
* Willing and able to actively cooperate with the prescribed course of standard dry eye medications and ocular surface microbiota transplantation therapy for the study duration.
* Voluntarily agrees to participate and signs the informed consent form.
* Healthy Donor Group:
* A family member of a participating subject.
* Aged 18 to 50 years.
* Normal ocular surface structure and function, with no ocular diseases or related symptoms, and good visual function.
Exclusion Criteria
* History of systemic chronic diseases (e.g., uncontrolled diabetes, autoimmune disorders).
* Current or past history of eyelid abnormalities, conjunctival disease, or lacrimal duct obstruction.
* History of any ocular surgery or regular wear of corneal contact lenses.
* Active infection in the eye(s) or any other part of the body.
* History of multiple episodes of viral keratitis or presence of significant neurotrophic keratitis.
* Any other condition deemed by the investigator to be unsuitable for participation.
* Healthy Donor Group:
* Known infectious diseases (e.g., HIV, Hepatitis B).
* Signs or symptoms suggestive of active ocular surface infection or other viral infections.
* Current or past history of eyelid, conjunctival, or lacrimal duct diseases.
* Use of systemic medications (including antibiotics), traditional Chinese herbal medicine, or probiotic supplements within 1 month prior to screening.
* Pregnancy, lactation, or any other condition that may potentially affect the study outcomes.
18 Years
70 Years
ALL
Yes
Sponsors
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Second Affiliated Hospital of Nanchang University
OTHER
Responsible Party
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Yifeng Yu
Associate Chief Physician, Ph.D.
Locations
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Yifeng Yu
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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yifeng Yu, Ph.D
Role: primary
Other Identifiers
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IIT-I-2025-081
Identifier Type: -
Identifier Source: org_study_id