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NCT04656197 Clinical Trial

The Ocular Microbiome in Patients With Dry Eye Disease

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04656197
Other study ID # BASEC 2019-01670
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date March 4, 2020

Study information
Verified date November 2020
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ocular microbiome
Taxonomical and functional characterization of the ocular microbiome

Locations
Country Name City State
Switzerland Department of Ophthalmology, Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of the ocular microbiome at baseline
Secondary Identification of differences of the ocular microbiome between patients and controls at baseline
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