Donor ocular microbiota transplant to treat dry eye

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.

This test tries transplanting healthy donor ocular surface microbiota alongside standard treatment to see if it improves symptoms and eye surface health in adults with moderate to severe dry eye.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07298811 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study gives adults with moderate to severe dry eye either an ocular surface microbiota transplant or a placebo in addition to standard dry eye medications. Healthy family members serve as screening donors for the transplant material. The study measures safety, symptom change, and objective ocular surface signs over a scheduled follow-up period. Investigators will also analyze changes in the structure of the ocular surface microbiota before and after treatment.

Who should consider this trial

Good fit: Adults 18–70 years old with moderate to severe mixed dry eye (including FBUT ≤ 5 seconds and at least one symptom) who can follow prescribed therapies and provide informed consent are appropriate candidates.

Not a fit: Patients with uncontrolled systemic chronic diseases, significant ocular comorbidities, or those who do not meet the moderate-to-severe dry eye criteria or cannot comply with study procedures are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the transplant could reduce dry eye symptoms and restore a healthier ocular surface microbiota, potentially decreasing dependence on chronic topical therapies.

How similar studies have performed: Ocular surface microbiota transplantation is largely experimental with limited human data, though microbiome-based therapies in other body sites have produced mixed early results.

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.

Where this trial is running

Nanchang, Jiangxi

• Yifeng Yu — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Yifeng Yu, Ph.D

Conditions Dry Eye; dry eye; ocular surface diseases; Microbiota transplantation