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Recruiting NCT04658238

Ocular Microbiome and Immune System in Dry Eyes

— Observational Dry Eye Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ocular microbiome, Ocular immune system.
Who it may be relevant to
Registry conditions: Dry Eye Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The primary objectives of this study are the characterization of the ocular microbiome as well as of the local immune system in participants with and without dry eye disease. Secondary objectives are the identification of differences in the ocular microbiome as well as in the immune system between participants with and without dry eye disease to ultimately find associations between the ocular microbiome and the immune system in dry eye disease.

Detailed description

Although dry eye disease is considered to be one of the most common ocular surface diseases worldwide, treatment options are only very limited and severe side effects are common. However, recent studies showed that the ocular microbiome may be crucial for maintaining ocular surface homeostasis. Disruption of this homeostasis, called dysbiosis, may lead to inflammation that is a key component in the pathogenesis of dry eye disease. It has been suggested that bacteria are invasive in ocular mucosal tissue, thereby effectively hidden from clearance by the local immune system and rendering the inflammation chronic. Therefore, the investigators hypothesize that the ocular microbiome may induce changes in the mucosal immune system of the eye, which in turn may accelerate the development of dry eyes. Since there is a crucial role of both, the ocular microbiome and the local mucosal immune system, on several diseases, the overall aim of this project is to assess the associations of the mucosal immune system and the ocular microbiome in dry eye disease.

Interventions

  • Other Ocular microbiome
    Taxonomical and functional characterization of the ocular microbiome
  • Other Ocular immune system
    Functional characterization of the tear fluid proteome, histology of conjunctival tissue and molecular assays

Primary outcome measures

  • Ocular microbiome and local immune system in controls [Time frame: At baseline]
  • Ocular microbiome and local immune system in patients [Time frame: At baseline]
Secondary outcome measures (2)
  • Differences of the ocular microbiome and the local immune system between patients and controls [Time frame: At baseline]
  • Correlations between the ocular microbiome and the local immune system [Time frame: At baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • Department of Ophthalmology, Inselspital — Bern

Publications

  • Sporri L, Studer JM, Kreuzer M, Rotzetter J, Scharer D, Largiader CR, Jaggi D, Zinkernagel MS, Zysset-Burri DC. Linking the microbiome to the complement system in geographic atrophy. NPJ Genom Med. 2026 Feb 2;11(1):14. doi: 10.1038/s41525-026-00550-7. PMID 41629364

Identifiers

NCT: NCT04658238 · BASEC 2020-00775

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗