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Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease: a Randomized, Single-blind,-Controlled Trial.

NCT07298811•Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.

Detailed Description

Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Dry Eye Patient Group:
•* 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.
+1 more criteria

Exclusion Criteria

•Dry Eye Patient Group:
•* 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.
+3 more criteria

Locations (1)

Yifeng Yu

Nanchang, Jiangxi, China

Key Dates

Start Date

October 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

December 23, 2025

Enrollment

ESTIMATED participants

Conditions

Dry Eye

Interventions

Ocular surface microbiota transplantation

BIOLOGICAL

Placebo Group

BIOLOGICAL

Contacts

Yifeng Yu, Ph.D

CONTACT

+8613979180258 171018170@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Inclusion Criteria

Exclusion Criteria

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