NCT04193917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed
Last Updated

December 24, 2024

Status Verified

July 1, 2024

Enrollment Period

4.2 years

First QC Date

December 4, 2019

Last Update Submit

December 19, 2024

Conditions

Ocular Surface Microbiome

Keywords

Ocular surface microbiomeTemporal stabilityConfounding factors

Outcome Measures

Primary Outcomes (2)

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

    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

    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

Study Arms (1)

conjunctival swab

OTHER

A conjunctival swab of both eyes will be taken

Diagnostic Test: Conjunctival swab

Interventions

Conjunctival swabDIAGNOSTIC_TEST

A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.

conjunctival swab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven, Department of Ophthalmology

Leuven, 3000, Belgium

Location

Study Officials

  • Heleen Delbeke, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: A conjunctival swab will be taken from healthy volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 10, 2019

Study Start

November 24, 2019

Primary Completion

January 23, 2024

Study Completion

January 23, 2024

Last Updated

December 24, 2024

Record last verified: 2024-07

Locations

BE(1)