Ocular Surface MicrobiomeCoFaNCT04193917
Confounding Factors in Ocular Surface Microbiome Research
A study testing Conjunctival swab in people with Ocular Surface Microbiome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Microbiome
- What is being tested?
- Conjunctival swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Nov 2019to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is fluent in written and verbal Dutch
- The subject is capable of giving informed consent
Who cannot join
- Use of glaucoma drops
- Use of antibiotic drops < 1 month before sampling
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven, Department of Ophthalmology
Leuven, 3000
About this study
To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.
Read the 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.
- Conditions
- Ocular Surface Microbiome
- Being tested
- Conjunctival swab
- Keywords
- Ocular surface microbiome, Temporal stability, Confounding factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjunctival swabDiagnostic test
A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| conjunctival swab | Other | A conjunctival swab of both eyes will be taken Receives: Diagnostic Test: Conjunctival swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 20 minutes for the first sample and questionnaire, 5 minutes for all other visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start24 Nov 2019
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface MicrobiomeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A conjunctival swab will be taken from healthy volunteers
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heleen Delbeke, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193917
- Sponsor's protocol ID
- S63155
- Acronym
- CoFa
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2019
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confounding Factors in Ocular Surface Microbiome Research
- ClinicalTrials.gov ID
- NCT04193917
- Acronym / sponsor ID
- CoFa / S63155
- Conditions
- Ocular Surface Microbiome
- Keywords
- Ocular surface microbiome, Temporal stability, Confounding factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 24 Nov 2019 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A conjunctival swab will be taken from healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| conjunctival swab | Other | Diagnostic Test: Conjunctival swabA conjunctival swab of both eyes will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is fluent in written and verbal Dutch
- The subject is capable of giving informed consent
Key exclusion criteria (2 listed)
- Use of glaucoma drops
- Use of antibiotic drops < 1 month before sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjunctival swabA conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire. | Diagnostic test | conjunctival swab |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heleen Delbeke, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conjunctival swab in people with Ocular Surface Microbiome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.