The Ocular Microbiome in Patients With Dry Eye Disease

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT04656197
Collaborator
(none)
80
1
5.1
15.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ocular 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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Identification of the Ocular Microbiome and Its Role on Dry Eye Disease
Actual Study Start Date :
Sep 30, 2019
Actual Primary Completion Date :
Mar 4, 2020
Actual Study Completion Date :
Mar 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with dry eye disease

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

Healthy controls

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

Outcome Measures

Primary Outcome Measures

  1. Characterization of the ocular microbiome [at baseline]

Secondary Outcome Measures

  1. Identification of differences of the ocular microbiome between patients and controls [at baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, Inselspital Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Martin Zinkernagel, Prof. Dr. Dr., Department of Ophthalmology, Inselspital, Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT04656197
Other Study ID Numbers:
  • BASEC 2019-01670
First Posted:
Dec 7, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Inselspital, Berne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2020