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

ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 to 70 years, male or female.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ocular surface microbiota transplantation
  • Placebo Group

Treatment groups

40 Participants
are divided into 2 treatment groups