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Completed

NCT Number: NCT04656197

The Ocular Microbiome in Patients With Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Inselspital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocular microbiome

Other

Taxonomical and functional characterization of the ocular microbiome

Primary outcomes

  1. Characterization of the ocular microbiome

    Time frame: at baseline

Secondary outcomes

  1. Identification of differences of the ocular microbiome between patients and controls

    Time frame: at baseline

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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