NCT04658238

Ocular Microbiome and Immune System in Dry Eyes

Associations of the Ocular Microbiome and the Immune System in Dry Eye Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
OTHER	Ocular microbiome	Taxonomical and functional characterization of the ocular microbiome
OTHER	Ocular immune system	Functional characterization of the tear fluid proteome, histology of conjunctival tissue and molecular assays

Timeline

• Start date: 2020-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-12-08
• Last updated: 2025-04-01

Locations

1 site across 1 country: Switzerland