NCT Number: NCT04658238
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bern, 3010, Switzerland
Location status: Recruiting
Denise Zysset, PhD
CONTACT
Denise Zysset, PhD
SUB_INVESTIGATOR
Martin Zinkernagel, Prof. Dr. Dr.
CONTACT
Martin Zinkernagel, Prof. Dr. Dr.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taxonomical and functional characterization of the ocular microbiome
Functional characterization of the tear fluid proteome, histology of conjunctival tissue and molecular assays
Time frame: At baseline
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
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
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
Identification of correlations between the ocular microbiome and the local immune system. For variables used see Outcome 3.
Time frame: 3-6 months after baseline
Sequential sample collection of eye swabs
Contact information is provided by the study sponsor or research team.
Denise Zysset, PhD
CONTACT
Martin Zinkernagel, Prof. Dr. Dr.
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Associations of the Ocular Microbiome and the Immune System in Dry Eye Disease
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