Dry Eye DiseaseNCT02554084
Optical Coherence Tomography of Tear Film Dynamics In-Vivo
A study testing Optical Coherence Tomography in people with Dry Eye Disease, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new instrument that takes digital images of tear film (a thin film that coats the eye that is made up of oil and water). The investigators are interested in measuring how the thickness of the tear film varies through time. 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 Disease
- What is being tested?
- Optical Coherence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2017
- 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
- Clinically diagnosed Dry Eye Disease
- Normal individuals (those without a dry eye diagnosis and without eye abnormalities)
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study
- Either gender
- Any racial or ethnic origin
Who cannot join
- Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the study visit
- Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy
- Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago
- Use of soft or hard contact lenses 6 hours prior to visit
- Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions)
- Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV) (subjects will be asked to self-report these conditions)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate a new instrument that takes digital images of tear film (a thin film that coats the eye that is made up of oil and water). The investigators are interested in measuring how the thickness of the tear film varies through time. The goal is to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future clinical diagnosis.
- Conditions
- Dry Eye Disease
- Being tested
- Optical Coherence Tomography
- 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.
Optical Coherence TomographyOther
Digital images of tear film
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Disease | Experimental | Optical Coherence Tomography Receives: Other: Optical Coherence Tomography |
| Normals | Active comparator | Optical Coherence Tomography Receives: Other: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of lipid layers on patient cornea (nm)
Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of lipid-layer thickness.
Measured: participants will be seen once within a one year period, on average within 1 month
Thickness of aqueous layers on patient cornea (um)
Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of aqueous-layer thickness.
Measured: participants will be seen once within a one year period, on average within 1 month
Secondary outcomes (2)
Thickness maps dynamics
Measured through optical coherence tomography
Measured: participants will be seen once within a one year period, on average within 1 month
Optical aberrations
Measured through optical coherence tomography
Measured: participants will be seen once within a one year period, on average within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannick Rolland-Thompson, University of Rochester
- Investigators
- Jannick Rolland, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554084
- Sponsor's protocol ID
- 52165
- Status last verified
- Apr 2018
- First submitted
- 24 Nov 2014
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of Tear Film Dynamics In-Vivo
- ClinicalTrials.gov ID
- NCT02554084
- Acronym / sponsor ID
- 52165
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Sep 2015 (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 evaluate a new instrument that takes digital images of tear film (a thin film that coats the eye that is made up of oil and water). The investigators are interested in measuring how the thickness of the tear film varies through time. The goal is to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future clinical diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Disease | Experimental | Other: Optical Coherence TomographyOptical Coherence Tomography |
| Normals | Active comparator | Other: Optical Coherence TomographyOptical Coherence Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically diagnosed Dry Eye Disease
- Normal individuals (those without a dry eye diagnosis and without eye abnormalities)
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study
Key exclusion criteria (6 listed)
- Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the study visit
- Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy
- Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago
- Use of soft or hard contact lenses 6 hours prior to visit
- Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions)
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 |
|---|---|---|
| Optical Coherence TomographyDigital images of tear film | Other | Dry Eye Disease, Normals |
Primary outcome
Thickness of lipid layers on patient cornea (nm)
Time frame: participants will be seen once within a one year period, on average within 1 month
Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of lipid-layer thickness.
Thickness of aqueous layers on patient cornea (um)
Time frame: participants will be seen once within a one year period, on average within 1 month
Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of aqueous-layer thickness.
2 secondary outcomes
Thickness maps dynamics
Time frame: participants will be seen once within a one year period, on average within 1 month
Optical aberrations
Time frame: participants will be seen once within a one year period, on average within 1 month
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 20 Apr 2018.
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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.
Jannick Rolland, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with Dry Eye Disease, run by University of Rochester 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 7 inclusion and 6 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 20 Apr 2018. 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?
Thickness of lipid layers on patient cornea (nm) (time frame: participants will be seen once within a one year period, on average within 1 month). 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 20 Apr 2018.