ClinicalTrials.Veeva

Menu

Ocular Microbiome and Immune System in Dry Eyes

I

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Dry Eye Disease

Treatments

Other: Ocular microbiome
Other: Ocular immune system

Study type

Observational

Funder types

Other

Identifiers

NCT04658238
BASEC 2020-00775

Details and patient eligibility

About

The primary objectives of this study are the characterization of the ocular microbiome as well as of the local immune system in participants with and without dry eye disease. Secondary objectives are the identification of differences in the ocular microbiome as well as in the immune system between participants with and without dry eye disease to ultimately find associations between the ocular microbiome and the immune system in dry eye disease.

Full description

Although dry eye disease is considered to be one of the most common ocular surface diseases worldwide, treatment options are only very limited and severe side effects are common. However, recent studies showed that the ocular microbiome may be crucial for maintaining ocular surface homeostasis. Disruption of this homeostasis, called dysbiosis, may lead to inflammation that is a key component in the pathogenesis of dry eye disease. It has been suggested that bacteria are invasive in ocular mucosal tissue, thereby effectively hidden from clearance by the local immune system and rendering the inflammation chronic. Therefore, the investigators hypothesize that the ocular microbiome may induce changes in the mucosal immune system of the eye, which in turn may accelerate the development of dry eyes. Since there is a crucial role of both, the ocular microbiome and the local mucosal immune system, on several diseases, the overall aim of this project is to assess the associations of the mucosal immune system and the ocular microbiome in dry eye disease.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Willing to sign informed consent
  • 18 years of age or older

Exclusion criteria

  • Not willing or able to sign informed consent
  • Younger than 18 years
  • 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

Trial design

600 participants in 2 patient groups

Dry eye disease
Description:
Patients with dry eye disease
Treatment:
Other: Ocular immune system
Other: Ocular microbiome
Healthy controls
Description:
Healthy controls without dry eye disease
Treatment:
Other: Ocular immune system
Other: Ocular microbiome

Trial contacts and locations

1

Loading...

Central trial contact

Denise Zysset, PhD; Martin Zinkernagel, Prof. Dr. Dr.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems