Clinical trial Recruiting at 1 site Observational Ages 18 and up

Exploring the link between the eye's microbiome and immune system in dry eye disease

Official title: Associations of the Ocular Microbiome and the Immune System in Dry Eye Disease

Run by Insel Gruppe AG, University Hospital Bern · NCT04658238 · Data updated 2026-11-12

This study looks at the eye's bacteria and immune system in people with and without dry eye disease to see how they might be connected and what could help improve symptoms.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Locations1 site (Bern)
StatusRecruiting
StartedOctober 1, 2020
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 1, 2025
Trial IDNCT04658238 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older, both with and without dry eye disease.

Probably not a fit

Patients who have recently used systemic or topical antibiotics or have undergone ocular surgery in the past three months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the ocular microbiome and the local immune system in individuals with and without dry eye disease. By comparing these two groups, the study seeks to identify differences in the ocular microbiome and immune responses that may contribute to the development of dry eye disease. The researchers hypothesize that dysbiosis of the ocular microbiome could lead to chronic inflammation, impacting the mucosal immune system and exacerbating dry eye symptoms. The findings could provide insights into the underlying mechanisms of dry eye disease and potential new avenues for treatment.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of dry eye disease, potentially offering new therapeutic strategies.

How similar studies have gone: While the role of the ocular microbiome in eye health is an emerging field, similar studies have shown promising results in understanding the microbiome's impact on various diseases.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Willing to sign informed consent
* 18 years of age or older

Exclusion Criteria:

* Not willing or able to sign informed consent
* Younger than 18 years
* Recent (3 month) history of use of systemic and/or topical antibiotics
* Usage of medical eye drops (Lacrycon and other moisturizing eye drops are allowed)
* Recent (3 month) history of ocular surgery

Where it's running

  • Department of Ophthalmology, Inselspital
    Bern, Switzerland
    Recruiting

Study contacts

  • Principal investigator: Martin Zinkernagel, Prof. Dr. Dr. — Department of Ophthalmology, Inselspital
  • Study coordinator: Martin Zinkernagel, Prof. Dr. Dr.
  • Email: martin.zinkernagel@insel.ch
  • Phone: +41 31 632 95 65

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.