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Recruiting NCT07298811

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

Phase I / Phase II Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ocular surface microbiota transplantation, Placebo Group.
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Biological Ocular surface microbiota transplantation
    Ocular surface microbiota transplantation
  • Biological Placebo Group
    Fake transplant operation

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]
  • 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.]
  • 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 Film Break-Up Time (TBUT) [Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]
  • 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.]
  • Change in tear fluid inflammatory cytokine levels [Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Yifeng Yu — Nanchang

Identifiers

NCT: NCT07298811 · IIT-I-2025-081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗