Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07298811

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Normal ocular surface structure and function, with no ocular diseases or related symptoms, and good visual function.

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.
  • 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.

Treatment and study plan

Ocular surface microbiota transplantation

Biological

Ocular surface microbiota transplantation

Placebo Group

Biological

Fake transplant operation

Primary outcomes

  1. Score on the Visual Analog Scale (VAS) for Ocular Discomfort

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    The severity of ocular discomfort (e.g., dryness, pain) is assessed using a 100-mm Visual Analog Scale (VAS). Participants mark their level of discomfort on a line from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The score is the distance measured in millimeters (mm). A higher score indicates more severe symptoms (worse outcome).

Secondary outcomes

  1. Corneal Fluorescein Staining Score (using the NEI scale)

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Corneal epithelial damage is assessed by fluorescein staining and graded according to the National Eye Institute (NEI) scale. Each of the five corneal areas is scored from 0 (no staining) to 3 (severe confluent staining). The total score is the sum of all areas, ranging from 0 to 15. A higher score indicates more severe corneal damage (worse outcome).

  2. Change in conjunctival sac microbiota composition assessed by 16S rRNA gene sequencing

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Microbiota from conjunctival sac swab samples is analyzed using 16S rRNA gene sequencing. Key outcomes include: 1) Alpha diversity change (Shannon Index, unitless), where a higher index indicates greater microbial richness and evenness; 2) Beta diversity change (Weighted UniFrac distance, unitless), measuring compositional shifts between samples; and 3) Change in relative abundance (%) of specific bacterial taxa (e.g., *Corynebacterium*, *Pseudomonas*).

  3. Result of Schirmer I Test (without anesthesia)

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Tear production is measured by the Schirmer I test (without topical anesthesia). A standardized paper strip is placed in the lateral canthus for 5 minutes. The length of wetting is measured in millimeters (mm). A lower value indicates reduced tear secretion.

  4. Tear Film Break-Up Time (TBUT)

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Tear film stability is assessed by measuring the tear film break-up time (TBUT). After instillation of fluorescein, the time interval between the last complete blink and the first appearance of a dry spot on the cornea is recorded in seconds (s). A shorter time indicates greater tear film instability.

  5. Score on the Ocular Surface Disease Index (OSDI) Questionnaire

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Symptoms related to dry eye disease and their impact on vision-related function are assessed using the Ocular Surface Disease Index (OSDI) questionnaire. The total score ranges from 0 to 100, calculated based on responses to 12 items. A higher score indicates more severe disability (worse outcome).

  6. Change in tear fluid inflammatory cytokine levels

    Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.

    Levels of inflammatory cytokines in tear fluid samples are measured using a multiplex immunoassay (e.g., Luminex assay or ELISA). The concentration of specific cytokines (e.g., IL-1β, IL-6, IL-8, TNF-α) is reported in picograms per milliliter (pg/mL). An increase in concentration indicates a higher level of inflammation (worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Yifeng Yu, Ph.D

CONTACT

[email protected]

+8613979180258

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.