The Ocular Microbiome in Patients With Dry Eye Disease

Study Overview
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Brief Summary
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The primary objective of this study is the characterization of the ocular microbiome in a healthy cohort and in patients with dry eye disease using whole-metagenome shotgun sequencing. Secondary objectives are the identification of differences between the ocular microbiome of healthy controls and patients with dry eye disease as well as between the ocular and the gut microbiome.

Detailed Description
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Dry eye disease is considered to be the most common ocular surface disease worldwide. Recent studies revealed that the ocular microbiome plays an important role in maintaining ocular surface homeostasis and health. Commensals colonizing the ocular surface seem to support the local innate immune system. As the ocular microbiome coordinates several functions together with ocular mucosal and immune epithelial cells, alteration of the microbiome can lead to changes in the integrity of the ocular surface. This can lead to the development of ocular surface related diseases such as dry eye. Inflammation seems to be a key component of dry eye disease in terms of being a propagator as well as a consequence. In contrast to earlier approaches of identifying the microbiome by cultivating with only limited results, it is now possible to provide more details regarding all microbiota residing on the ocular surface due to modern sequencing techniques. Thus, the overall aim of this study is the identification of the role of the ocular microbiome in dry eye disease.

Official Title
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Identification of the Ocular Microbiome and Its Role on Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: Ocular microbiome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to sign informed consent Patients 60 years of age or older Exclusion Criteria: Patients not willing or able to sign informed consent Patients younger than 60 years Smoking Wearing contact lenses 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with dry eye disease<br> | Other: Ocular microbiome<br>* Taxonomical and functional characterization of the ocular microbiome<br>|
| Healthy controls<br> | Other: Ocular microbiome<br>* Taxonomical and functional characterization of the ocular microbiome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the ocular microbiome |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of differences of the ocular microbiome between patients and controls |  | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular metagenome