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NCT Number: NCT07298811

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Yifeng Yu

Nanchang, Jiangxi, 330008, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients with moderate-to-severe DED were as follows: (1) age 18-70 years, regardless of sex; (2) a diagnosis of DED based on the 2016 Asian Dry Eye Society guidelines and the TFOS DEWS II criteria. Moderate-to-severe DED was defined as meeting the DED diagnostic criteria and having at least one of the following: an OSDI score ≥23 (indicating symptomatic dry eye), FBUT ≤5 s, or Schirmer I test ≤5 mm/5 min; (3) willingness and ability to comply with routine treatment and OSM transplantation during the study period. (4) Voluntary participation in this clinical study and provision of written informed consent. Exclusion criteria were as follows: (1) history of chronic diseases; (2) current or previous eyelid, conjunctival, or lacrimal duct disease; (3) history of ocular surgery or contact lens wear; (4) concurrent active infection of the eye or other systemic sites; (5) history of recurrent viral keratitis or the presence of significant neurotrophic keratitis; (6) use of systemic medications within the past 2 months; (7) severe organ disease; (8) immunodeficiency; (9) participation in another clinical trial within the past month or current participation in another clinical trial; (10) allergy to any component of the study device or study reagents; (11) chronic use of medications or probiotic-containing supplements; (12) unhealthy lifestyle habits or environmental factors (e.g., smoking or alcohol abuse); (13) any other conditions considered incompatible with the study.

Healthy donor inclusion criteria were as follows: (1) Age 18-50 years; (2) The donor for OSM transplantation was a family member of the recipient and had a consanguineous (biological) relationship with the recipient; (3) Normal structure and function of the ocular surface, no ocular diseases or related symptoms, and normal visual function. Exclusion criteria were as follows: (1) infectious diseases such as HIV or hepatitis B; (2) potential viral or other infections of the ocular surface; (3) current or previous eyelid, conjunctival, or lacrimal duct disease; (4) use of systemic medications, antibiotics, herbal medicines, or probiotics within the past 1 month; (5) pregnancy or any other condition that may affect the study results.

Treatment and study plan

Ocular surface microbiota transplantation

Biological

Ocular surface microbiota transplantation

placebo transplantation Group

Biological

placebo transplantation operation

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Total Corneal Fluorescein Staining (tCFS)

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

    A fluorescein sodium strip moistened with sterile saline was applied to the inferotemporal conjunctival sac. The subject was instructed to blink several times, after which the tear film was examined under a slit lamp using cobalt blue light. tCFS was graded according to the modified National Eye Institute (NEI) scale. The stained cornea was divided into five zones (central, superior, temporal, nasal, and inferior), each scored on a scale of 0 to 4. The individual zone scores were summed to obtain a total score (range, 0-20).

  2. Change in conjunctival sac microbiota composition assessed by 16S rRNA gene sequencing

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

    Microbiota from conjunctival sac swab samples is analyzed using 16S rRNA gene sequencing. Key outcomes include: 1) Alpha diversity change (Shannon Index, unitless), where a higher index indicates greater microbial richness and evenness; 2) Beta diversity change (Weighted UniFrac distance, unitless), measuring compositional shifts between samples; and 3) Change in relative abundance (%) of specific bacterial taxa (e.g., *Corynebacterium*, *Pseudomonas*).

  3. Schirmer I Test

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

    The subject was instructed to close the eyes, and timing was started immediately. After 5 minutes, the strip was removed and the length of the wetted portion was measured. The length of wetting is measured in millimeters (mm). A lower value indicates reduced tear secretion.

  4. Fluorescein Break-Up Time (FBUT)

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

    Tear film stability is assessed by measuring the tear film break-up time. After instillation of fluorescein, the time interval between the last complete blink and the first appearance of a dry spot on the cornea is recorded in seconds (s). A shorter time indicates greater tear film instability.

  5. Score on the Ocular Surface Disease Index (OSDI) Questionnaire

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

    Symptoms related to dry eye disease and their impact on vision-related function are assessed using the Ocular Surface Disease Index (OSDI) questionnaire. The total score ranges from 0 to 100. A higher score indicates more severe disability (worse outcome).

  6. Change in tear fluid inflammatory cytokine levels

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

    Levels of inflammatory cytokines in tear fluid samples are measured using a multiplex immunoassay (e.g., Luminex assay or ELISA). The concentration of specific cytokines (e.g., IL-1β, IL-6, IL-8, TNF-α) is reported in picograms per milliliter (pg/mL). An increase in concentration indicates a higher level of inflammation (worse outcome).

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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