Ocular Microbiome and Immune System in Dry Eyes

Last updated: March 26, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Ocular immune system

Ocular microbiome

Clinical Study ID

NCT04658238
BASEC 2020-00775
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to sign informed consent

  • 18 years of age or older

Exclusion

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

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Ocular immune system
Phase:
Study Start date:
October 01, 2020
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Department of Ophthalmology, Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

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