Dry Eye SyndromesNCT02298881
Ocular Surface Microbiome
An observational study of Dry Eye Syndromes, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 1 May 2021
- 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: Adult patients from the investigators' practices at the University of Washington Eye Institute
Who may be able to join
- Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60
- Subjects with and Ocular Surface disease Index score less than 30
- Males and females age 18 or older
Who cannot join
- Contact lens wear
- Use of oral or topical antibiotics in past 6 months
- Use of prescription eye medication in past 6 months
- Penetrating ocular or keratoplasty surgery in last 12 months
- Children under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Medicine Eye Institute
Seattle, Washington, 98104
About this study
Official title: Diversity and Dynamic Stability of the Ocular Surface Microbiome
The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.
Read the detailed description
"Dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye, Microbiome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dry eye group | People with dry eye symptoms | |
| Non-dry eye group | People with no dry eye symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
To catalog the bacteria and other micro-organisms that are naturally found on the eye surface.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJul 2013
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Principal investigator, Russell Van Gelder, University of Washington
- Investigators
- Russell N VanGelder, MD, PhD, Principal investigator, UW Medicine Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298881
- Sponsor's protocol ID
- 43018
- Other IDs
- 1R01EY022038-01A1
- Status last verified
- May 2021
- First submitted
- 18 Nov 2014
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Doan T, Akileswaran L, Andersen D, Johnson B, Ko N, Shrestha A, Shestopalov V, Lee CS, Lee AY, Van Gelder RN. Paucibacterial Microbiome and Resident DNA Virome of the Healthy Conjunctiva. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5116-5126. doi: 10.1167/iovs.16-19803.
PubMed 27699405
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diversity and Dynamic Stability of the Ocular Surface Microbiome
- ClinicalTrials.gov ID
- NCT02298881
- Acronym / sponsor ID
- 43018
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- Jul 2013
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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 purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.
Detailed description
"Dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry eye group | – | –People with dry eye symptoms |
| Non-dry eye group | – | –People with no dry eye symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients from the investigators' practices at the University of Washington Eye Institute
Key inclusion criteria (3 listed)
- Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60
- Subjects with and Ocular Surface disease Index score less than 30
- Males and females age 18 or older
Key exclusion criteria (5 listed)
- Contact lens wear
- Use of oral or topical antibiotics in past 6 months
- Use of prescription eye medication in past 6 months
- Penetrating ocular or keratoplasty surgery in last 12 months
- Children under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To catalog the bacteria and other micro-organisms that are naturally found on the eye surface.
Time frame: 6 months
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 7 May 2021.
- Derived from this study: PubMed 27699405Doan T, Akileswaran L, Andersen D, Johnson B, Ko N, Shrestha A, Shestopalov V, Lee CS, Lee AY, Van Gelder RN. Paucibacterial Microbiome and Resident DNA Virome of the Healthy Conjunctiva. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5116-5126. doi: 10.1167/iovs.16-19803.
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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.
Russell N VanGelder, MD, PhD principal investigator
UW Medicine Eye Institute
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 Dry Eye Syndromes, run by University of Washington 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 3 inclusion and 5 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 7 May 2021. 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?
To catalog the bacteria and other micro-organisms that are naturally found on the eye surface. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298881, which also lists 1 linked publication.
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 7 May 2021.