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

NCT07298811 | Recruiting Phase 1 DMC

• 1 other identifier: IIT-I-2025-081
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Keywords

dry eye; ocular surface diseases; Microbiota transplantation

Outcome Measures

Primary Outcomes (1)

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

  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).

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

Secondary Outcomes (6)

• Corneal Fluorescein Staining Score (using the NEI scale)

  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

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

• Result of Schirmer I Test (without anesthesia)

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

• Tear Film Break-Up Time (TBUT)

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

• Score on the Ocular Surface Disease Index (OSDI) Questionnaire

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

Study Arms (2)

Transplant group

ACTIVE COMPARATOR

Transplant operation to dry eye patients

Biological: Ocular surface microbiota transplantation

Placebo group

PLACEBO COMPARATOR

Fake transplantation to dry eye patients

Biological: Placebo Group

Interventions

Ocular surface microbiota transplantation BIOLOGICAL

Ocular surface microbiota transplantation

Transplant group

Placebo Group BIOLOGICAL

Fake transplant operation

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Yifeng Yu

Nanchang, Jiangxi, 330008, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Yifeng Yu, Ph.D

CONTACT

+8613979180258; 171018170@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Ph.D.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (1)