Confounding Factors in Ocular Surface Microbiome Research (CoFa)

December 19, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator will take a conjunctival sample of both eyes of a group of volunteers together with an extensive questionnaire. Furthermore, 50 volunteers will be sampled repeatedly during one year or two years.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The subject is fluent in written and verbal Dutch
  • The subject is capable of giving informed consent

Exclusion Criteria:

  • Use of glaucoma drops
  • Use of antibiotic drops < 1 month before sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: conjunctival swab
A conjunctival swab of both eyes will be taken
Diagnostic test: Conjunctival swab
A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment
Time Frame: 20 minutes for samples and filling the questionnaires
A conjunctival swab and extensive questionnaire will be taken to search for a core ocular surface microbiome and confounding factors
20 minutes for samples and filling the questionnaires
Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time
Time Frame: 20 minutes for the first sample and questionnaire, 5 minutes for all other visits
A conjunctival swab will be taken on different points in time to investigate the temporal stability of the conjunctival microbial flora
20 minutes for the first sample and questionnaire, 5 minutes for all other visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Heleen Delbeke, MD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2019

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S63155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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