Ocular Microbiome and Immune System in Dry Eyes

NCT04658238 | Recruiting

• 1 other identifier: BASEC 2020-00775
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Disease

Keywords

microbiome; immune system

Outcome Measures

Primary Outcomes (2)

• Ocular microbiome and local immune system in controls

  Qualitative and quantitative characterization of the ocular microbiome and the local immune system in participants with no signs of dry eye disease. The primary variable for the characterization of the ocular microbiome is the identification of microbial taxa and the functional analysis of the identified taxa using eye swabs and conjunctival tissue samples. The primary variable for the characterization of the immune system is the identification of components of the ocular mucosal immune system (i.e. immune cells, anti- and proinflammatory cytokines) using conjunctival tissue samples and tear fluid. Baseline factors such as age, sex, BMI, medication, risk factors for dry eyes such as smoking and contact lenses may have an influence on the ocular microbiome.

  At baseline

• Ocular microbiome and local immune system in patients

  Qualitative and quantitative characterization of the ocular microbiome and the local immune system in participants with clinical signs of dry eye disease. For primary variable for characterization see Outcome 1. The variables for grading of dry eyes are tear film osmolarity, split lamp examination, tear secretion and subjective measurement by the "Ocular Surface Disease Index©" (OSDI©)" questionnaire.

  At baseline

Secondary Outcomes (2)

• Differences of the ocular microbiome and the local immune system between patients and controls

  At baseline

• Correlations between the ocular microbiome and the local immune system

  At baseline

Other Outcomes (1)

• Stability of the ocular surface microbiome

  3-6 months after baseline

Study Arms (2)

Dry eye disease

Patients with dry eye disease

Other: Ocular microbiome; Other: Ocular immune system

Healthy controls

Healthy controls without dry eye disease

Other: Ocular microbiome; Other: Ocular immune system

Interventions

Ocular microbiome OTHER

Taxonomical and functional characterization of the ocular microbiome

Dry eye disease; Healthy controls

Ocular immune system OTHER

Functional characterization of the tear fluid proteome, histology of conjunctival tissue and molecular assays

Dry eye disease; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive ongoing recruitment of subjects attending routine follow-ups through the involved investigators in daily clinical practice at Department of Ophthalmology, Inselspital, Bern

You may qualify if:

• Willing to sign informed consent
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Stiftung OPOS: collaborator
• Fondation Bertarelli: collaborator

Study Sites (1)

Department of Ophthalmology, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

• 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. doi: 10.1038/s41525-026-00550-7. Online ahead of print.

  PMID: 41629364 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolated from swabs frozen conjunctival tissue frozen tear fluid

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Martin Zinkernagel, Prof. Dr. Dr.

  Department of Ophthalmology, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Zinkernagel, Prof. Dr. Dr.

CONTACT

+41 31 632 95 65; martin.zinkernagel@insel.ch

Denise Zysset, PhD

CONTACT

+41 31 632 85 10; denise.zysset@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CH (1)