Clinical trial NCT04656197: The Ocular Microbiome in Patients With Dry Eye Disease
Official title: Identification of the Ocular Microbiome and Its Role on Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Keywords: Ocular metagenome
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive ongoing recruitment of subjects attending routine follow-ups through the involved investigators in daily clinical practice at Department of Ophthalmology, Inselspital, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of the ocular microbiome
timeFrame: at baseline
Secondary outcomes:
measure: Identification of differences of the ocular microbiome between patients and controls
timeFrame: at baseline
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, Inselspital
Study officials:
affiliation: Department of Ophthalmology, Inselspital, Bern
name: Martin Zinkernagel, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zysset-Burri DC, Schlegel I, Lincke JB, Jaggi D, Keller I, Heller M, Lagache SB, Wolf S, Zinkernagel MS. Understanding the Interactions Between the Ocular Surface Microbiome and the Tear Proteome. Invest Ophthalmol Vis Sci. 2021 Aug 2;62(10):8. doi: 10.1167/iovs.62.10.8.