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The Ocular Microbiome in Patients With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT04656197
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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
Dry Eye Disease 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
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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 : September 30, 2019
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Characterization of the ocular microbiome [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. Identification of differences of the ocular microbiome between patients and controls [ Time Frame: at baseline ]

Biospecimen Retention:   Samples With DNA
DNA isolated from eye swabs

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656197


Locations
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Switzerland
Department of Ophthalmology, Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Martin Zinkernagel, Prof. Dr. Dr. Department of Ophthalmology, Inselspital, Bern
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04656197    
Other Study ID Numbers: BASEC 2019-01670
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Ocular metagenome
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases