Microbial ColonizationNCT05414994
Assessment of the Ocular Microbiome in Health and Disease
An observational study of Microbial Colonization and Eye Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Eye Diseases, Ophthalmopathy
- What is being tested?
- Eye swab
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 30 Sep 2026
- Phase
- Observational
- 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
Study population: We anticipate there will be approximately 20% failure rate due to the low bacterial load in these samples and so we will have to collect more samples to account for the loss of data. We estimate that 20 patients in each cohort of eyes with ocular disease - 100 total patients and 500 normal eyes will give us sufficient power to explore this topic.
Who may be able to join
- We will include subjects who meet all of the following criteria:
- 18 years of age or older
- Provide informed consent
- Cohort A - normal eyes with no ocular disease
- Cohort B - primary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months
- Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)
Show all 9Show fewer
- Cohort D - Dry AMD (age related macular degeneration)
- Cohort E - Wet AMD
- Cohort F - diabetic retinopathy
Who cannot join
- We will exclude subjects who meet all of the following criteria:
- Prior ocular disease either of the anterior or posterior segment
- Any medical comorbidities except well controlled DH and HTN
- Unable to follow up with study procedures as described
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.
Read the detailed description
The microbiome is defined as a community of microbial organisms that reside in a specific host niche. There is a growing body of literature on the association between gut microbiome and disease entities such as inflammatory bowel disease, colon cancer and presumably an association that might influence response to treatment in some patients.
Recent data suggest the existence of a resident ocular microbiota that may play a protective role in corneal infections [1-4]. However, not much is known about the ocular microbiome and its association with disease or response to treatment. The National Eye Institute (NEI) recently hosted a symposium to discuss challenges to characterize the ocular microbiome and its role in promoting or preventing ocular diseases. One of the major challenges discussed is the lack of a normative population- based database describing the ocular microbiome.
In response the NEI as part of the Anterior segment initiative put out an RFA requesting proposals on methods of collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies); processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites) and characterizing microorganisms in a low biomass niche, specifically the ocular surface using16S rRNA marker gene, whole metagenome sequencing (WMS), and metatranscriptomics approaches.
- Conditions
- Microbial Colonization, Eye Diseases, Ophthalmopathy
- Being tested
- Eye swab
- Medical subject headings
- Communicable Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye swabOther
This is a simple swab under the eyelids of both eyes
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | normal eyes with no ocular disease Receives: Other: Eye swab | |
| Cohort B | primary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months Receives: Other: Eye swab | |
| Cohort C | non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable) Receives: Other: Eye swab | |
| Cohort D | Dry AMD (age related macular degeneration) Receives: Other: Eye swab | |
| Cohort E | Wet AMD Receives: Other: Eye swab | |
| Cohort F | diabetic retinopathy, any stage Receives: Other: Eye swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Ocular Microbiome
Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.
Measured: 3 years
Secondary outcomes (1)
Whole Metagenome Sequencing Methods
Number of ocular microbial species in different age and ethnic groups by the development of whole metagenome sequencing methods optimized for low biomass samples to characterize the ocular surface (anterior segment) microbiome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start7 Sep 2023
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sapna Gangaputra, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414994
- Sponsor's protocol ID
- 10001
- Status last verified
- Oct 2026
- First submitted
- 19 May 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ocular Microbiome in Health and Disease
- ClinicalTrials.gov ID
- NCT05414994
- Acronym / sponsor ID
- 10001
- Conditions
- Microbial Colonization, Eye Diseases, Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 10 Jun 2022 (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.
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.
Detailed description
The microbiome is defined as a community of microbial organisms that reside in a specific host niche. There is a growing body of literature on the association between gut microbiome and disease entities such as inflammatory bowel disease, colon cancer and presumably an association that might influence response to treatment in some patients.
Recent data suggest the existence of a resident ocular microbiota that may play a protective role in corneal infections [1-4]. However, not much is known about the ocular microbiome and its association with disease or response to treatment. The National Eye Institute (NEI) recently hosted a symposium to discuss challenges to characterize the ocular microbiome and its role in promoting or preventing ocular diseases. One of the major challenges discussed is the lack of a normative population- based database describing the ocular microbiome.
In response the NEI as part of the Anterior segment initiative put out an RFA requesting proposals on methods of collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies); processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites) and characterizing microorganisms in a low biomass niche, specifically the ocular surface using16S rRNA marker gene, whole metagenome sequencing (WMS), and metatranscriptomics approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Eye swabnormal eyes with no ocular disease |
| Cohort B | – | Other: Eye swabprimary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months |
| Cohort C | – | Other: Eye swabnon-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable) |
| Cohort D | – | Other: Eye swabDry AMD (age related macular degeneration) |
| Cohort E | – | Other: Eye swabWet AMD |
| Cohort F | – | Other: Eye swabdiabetic retinopathy, any stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We anticipate there will be approximately 20% failure rate due to the low bacterial load in these samples and so we will have to collect more samples to account for the loss of data. We estimate that 20 patients in each cohort of eyes with ocular disease - 100 total patients and 500 normal eyes will give us sufficient power to explore this topic.
Key inclusion criteria (9 listed)
- 18 years of age or older
- Provide informed consent
- Cohort A - normal eyes with no ocular disease
- Cohort B - primary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months
- Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)
Key exclusion criteria (4 listed)
- Prior ocular disease either of the anterior or posterior segment
- Any medical comorbidities except well controlled DH and HTN
- Unable to follow up with study procedures as described
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 |
|---|---|---|
| Eye swabThis is a simple swab under the eyelids of both eyes | Other | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F |
Primary outcome
Normal Ocular Microbiome
Time frame: 3 years
Number of patients in middle Tennessee with a normal ocular microbiome by development of a normative database.
1 secondary outcome
Whole Metagenome Sequencing Methods
Time frame: 3 years
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Eye Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
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 9 inclusion and 4 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 21 Oct 2026. 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 United States. 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?
Normal Ocular Microbiome (time frame: 3 years). 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 21 Oct 2026.