Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT07298811

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

Led by Second Affiliated Hospital of Nanchang University · Updated on 2025-12-23

40

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years, male or female
  • Diagnosed with moderate to severe mixed dry eye
  • At least one dry eye symptom such as dryness, burning, fatigue, or vision fluctuation
  • Fluorescein tear film break-up time (FBUT) of 5 seconds or less
  • Willing and able to follow standard dry eye treatment and microbiota transplantation during the study
  • Voluntarily agrees and signs informed consent
  • Healthy donors must be family members aged 18 to 50 with normal eye health and no eye disease or symptoms
Not Eligible

You will not qualify if you...

  • History of uncontrolled systemic chronic diseases like diabetes or autoimmune disorders
  • Eyelid abnormalities, conjunctival disease, or lacrimal duct obstruction
  • Previous eye surgery or regular use of corneal contact lenses
  • Active eye or other body infections
  • History of multiple viral keratitis episodes or significant neurotrophic keratitis
  • Any condition the investigator judges unsuitable for participation
  • Healthy donors with infectious diseases such as HIV or Hepatitis B
  • Signs or symptoms of active eye surface or viral infections
  • History of eyelid, conjunctival, or lacrimal duct diseases
  • Use of systemic antibiotics, herbal medicines, or probiotics within one month before screening
  • Pregnancy, breastfeeding, or conditions that might affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yifeng Yu

Nanchang, Jiangxi, China, 330008

Actively Recruiting

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Research Team

Y

Yifeng Yu, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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