Health TrialsbyHealthPanel

Ocular Microbiome and Immune System in Dry Eyes

ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing to sign informed consent

18 years of age or older

Disqualifiers

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)

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Ocular microbiome

    Other intervention

    Taxonomical and functional characterization of the ocular microbiome

  • Ocular immune system

    Other intervention

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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Dry eye disease2 interventions
Group B: Healthy controls2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline
2

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.

Time frame
At baseline

Secondary outcomes

1

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

Identification of differences of the ocular microbiome and the local immune system between patients and controls. The variables used for the differentiation of these two cohorts in terms of the microbiome are the relative abundances of identified microbial taxa and of corresponding functional features (i.e. genes and pathways) of the taxa. The variables used for the differentiation of the cohorts in terms of the immune system are quantitative values of cytokines and immune cells.

Time frame
At baseline
2

Correlations between the ocular microbiome and the local immune system

Identification of correlations between the ocular microbiome and the local immune system. For variables used see Outcome 3.

Time frame
At baseline

Other outcomes

1

Stability of the ocular surface microbiome

Sequential sample collection of eye swabs

Time frame
3-6 months after baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Stiftung OPOS

Collaborator

Fondation Bertarelli

Collaborator

Source ClinicalTrials.gov
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