CoFa: Confounding Factors in Ocular Surface Microbiome Research

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04193917
Collaborator
(none)
450
1
26.2
17.2

Study Details

Study Description

Brief Summary

To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Conjunctival swab
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A conjunctival swab will be taken from healthy volunteersA conjunctival swab will be taken from healthy volunteers
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Confounding Factors in Ocular Surface Microbiome Research
Actual Study Start Date :
Nov 24, 2019
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Jan 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment [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

  2. Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven, Department of Ophthalmology Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04193917
Other Study ID Numbers:
  • S63155
First Posted:
Dec 10, 2019
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven

Study Results

No Results Posted as of May 23, 2022