NCT07298811CompletedPhase 1
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.
Second Affiliated Hospital of Nanchang University2 sites in 1 country30 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Score on the Visual Analog Scale (VAS) for Ocular Discomfort
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
ocular surface microbiota transplantation group
Active Comparator
Transplant operation to dry eye patients
Intervention: Ocular surface microbiota transplantation (Biological)
placebo transplantation group
Placebo Comparator
placebo transplantation to dry eye patients
Intervention: placebo transplantation Group (Biological)
Outcomes
Primary Outcomes
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
- Corneal Fluorescein Staining Score (using the NEI scale)(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(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Result of Schirmer I Test (without anesthesia)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Tear Film Break-Up Time (TBUT)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Change in tear fluid inflammatory cytokine levels(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Score on the Ocular Surface Disease Index (OSDI) Questionnaire(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Total Corneal Fluorescein Staining (tCFS)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Schirmer I Test(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Fluorescein Break-Up Time (FBUT)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
Investigators
Yifeng Yu
Associate Chief Physician, Ph.D.
Second Affiliated Hospital of Nanchang University
Study Sites (2)
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