Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Yifeng Yu
Nanchang, Jiangxi, China, 330008
Actively Recruiting
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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