Ocular Microbiome and Immune System in Dry Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Dry eye disease

Patients with dry eye disease

Ocular microbiome

Intervention Type OTHER

Taxonomical and functional characterization of the ocular microbiome

Ocular immune system

Intervention Type OTHER

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

Healthy controls

Healthy controls without dry eye disease

Ocular microbiome

Intervention Type OTHER

Taxonomical and functional characterization of the ocular microbiome

Ocular immune system

Intervention Type OTHER

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

Interventions

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