The Ocular Microbiome in Patients With Dry Eye Disease

NCT04656197 | Completed

• 1 other identifier: BASEC 2019-01670
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

Ocular metagenome

Outcome Measures

Primary Outcomes (1)

• Characterization of the ocular microbiome

  at baseline

Secondary Outcomes (1)

• Identification of differences of the ocular microbiome between patients and controls

  at baseline

Study Arms (2)

Patients with dry eye disease

Other: Ocular microbiome

Healthy controls

Other: Ocular microbiome

Interventions

Ocular microbiome OTHER

Taxonomical and functional characterization of the ocular microbiome

Healthy controls; Patients with dry eye disease

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients willing to sign informed consent
• Patients 60 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Ophthalmology, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34369983 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolated from eye swabs

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Martin Zinkernagel, Prof. Dr. Dr.

  Department of Ophthalmology, Inselspital, Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: September 30, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)