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The Ocular Microbiome in Patients With Dry Eye Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04656197
Enrollment
80
Registered
2020-12-07
Start date
2019-09-30
Completion date
2020-03-04
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

Ocular metagenome

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.

Interventions

Taxonomical and functional characterization of the ocular microbiome

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Characterization of the ocular microbiomeat baseline

Secondary

MeasureTime frame
Identification of differences of the ocular microbiome between patients and controlsat baseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026