Dry EyePhase 1/2NCT07298811
Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease
A Phase 1/2 study testing Ocular surface microbiota transplantation in people with Dry Eye, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Ocular surface microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Ocular surface microbiota transplantation, placebo transplantation
- Keywords
- Ocular surface microbiota transplantation, Dry eye, Adjunctive therapy, Preliminary study
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular surface microbiota transplantationBiological
Ocular surface microbiota transplantation
placebo transplantationBiological
placebo transplantation operation
| Study group | Role | What they receive |
|---|---|---|
| ocular surface microbiota transplantation group | Active comparator | Transplant operation to dry eye patients Receives: Biological: Ocular surface microbiota transplantation |
| placebo transplantation group | Placebo comparator | placebo transplantation to dry eye patients Receives: Biological: placebo transplantation |
| Healthy donor group | No intervention | Healthy volunteers who serve as donors for ocular surface microbiota (OSM) transplantation. Participants in this group undergo screening and ocular surface sample collection only. No therapeutic intervention or study drug is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Secondary outcomes (6)
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).
Measured: 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*).
Measured: 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.
Measured: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Fluorescein Break-Up Time (FBUT)
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.
Measured: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Score on the Ocular Surface Disease Index (OSDI) Questionnaire
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).
Measured: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Change in tear fluid inflammatory cytokine levels
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).
Measured: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start26 Dec 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298811
- Sponsor's protocol ID
- I-Yiyan Lun Shen[2025]No.(105)
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07298811
- Acronym / sponsor ID
- I-Yiyan Lun Shen[2025]No.(105)
- Conditions
- Dry Eye
- Keywords
- Ocular surface microbiota transplantation, Dry eye, Adjunctive therapy, Preliminary study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ocular surface microbiota transplantation group | Active comparator | Biological: Ocular surface microbiota transplantationTransplant operation to dry eye patients |
| placebo transplantation group | Placebo comparator | Biological: placebo transplantationplacebo transplantation to dry eye patients |
| Healthy donor group | No intervention | –Healthy volunteers who serve as donors for ocular surface microbiota (OSM) transplantation. Participants in this group undergo screening and ocular surface sample collection only. No therapeutic intervention or study drug is administered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular surface microbiota transplantationOcular surface microbiota transplantation | Biological | ocular surface microbiota transplantation group |
| placebo transplantationplacebo transplantation operation | Biological | placebo transplantation group |
Primary outcome
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).
6 secondary outcomes
Total Corneal Fluorescein Staining (tCFS)
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
Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Schirmer I Test
Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Fluorescein Break-Up Time (FBUT)
Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
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.
Change in tear fluid inflammatory cytokine levels
Time frame: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ocular surface microbiota transplantation in people with Dry Eye, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.