Confounding Factors in Ocular Surface Microbiome Research

Ocular Surface Microbiome Clinical Trial

— CoFa  

Official title:

Confounding Factors in Ocular Surface Microbiome Research

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04193917
• Other study ID #: S63155
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ocular Surface Microbiome

Intervention

Diagnostic Test:
• Conjunctival swab
A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, Department of Ophthalmology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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