Could 'Good' eye bacteria ease dry eye? new trial launches
NCT ID NCT07298811
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests whether transplanting healthy bacteria from the eye's surface can help people with moderate to severe dry eye. Forty participants will either receive the bacteria transplant or a fake procedure. Researchers will measure changes in eye discomfort and surface damage over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ocular surface microbiota transplantation
- What this could lead to
- If it works, this could offer a new way to manage dry eye by restoring healthy bacteria on the eye's surface.
- What could go wrong
- This is a very early, small trial (40 people) testing safety and basic effectiveness. The approach is novel and may not provide lasting relief or work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
30 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Yifeng Yu
Nanchang, Jiangxi, 330008, China
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