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

Second Affiliated Hospital of Nanchang University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye

Interventions

Ocular surface microbiota transplantationBIOLOGICAL

Ocular surface microbiota transplantation

placebo transplantation GroupBIOLOGICAL

placebo transplantation operation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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 for patients with moderate-to-severe DED 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. * Healthy donor 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.

Locations (1)

Yifeng Yu

Nanchang, Jiangxi, China

Outcomes

Primary Outcomes

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

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).

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

Secondary Outcomes

Total Corneal Fluorescein Staining (tCFS)

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).

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

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

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\*).

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

Schirmer I Test

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.

Data from ClinicalTrials.gov

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