The Ocular Microbiome in Patients With Dry Eye Disease

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: Ocular microbiome

• Registration Number: NCT04656197
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-09-30
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Status Verified: 2020-11
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Last Update Submitted: 2020-11-30
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with dry eye disease	Ocular microbiome	-
Healthy controls	Ocular microbiome	-

Primary Outcome Measures

Name	Time	Method
Characterization of the ocular microbiome	at baseline

Secondary Outcome Measures

Name	Time	Method
Identification of differences of the ocular microbiome between patients and controls	at baseline

Trial Locations

Locations (1)

Department of Ophthalmology, Inselspital; 🇨🇭 Bern, Switzerland