Dry Eye SyndromesNCT00761917
Diagnostic Evaluation of the Tear Film
An observational study of Dry Eye Syndromes, run by TearScience, Inc. at 8 sites in United States.
Trial summary
The objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs. 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
- What is being tested?
- Tear Film Analyzer
- Type of treatment
- Medical device
- How many people
- 229 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2008to Nov 2008
- 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: Subjects undergoing routine eye examination in ophthalmic practices
Who may be able to join
- Adults 18 year of age or older
- Willing and able to comply with study exam procedure
Who cannot join
- Eyelid abnormality or ocular surface condition affecting ability to visualize tear film
- Women who are pregnant or nursing
- Any of the following conditions within specified timeframe prior to study participation:
- Instillation of eye drops
- Contact lens wear
- Use of oil-based facial cosmetics
Show all 9Show fewer
- Swimming in chlorinated pool
- Eye examination procedures that may affect the tear film
- Participation in another ophthalmic clinical trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Bloomington, Minnesota
Study site
Charlotte, North Carolina
Study site
Chesterfield, Missouri
Study site
Edgewood, Kentucky
Study site
Fayetteville, Arkansas
Study site
Henderson, North Carolina
Study site
Morrow, Georgia
Study site
Oak Lawn, Illinois
About this study
Official title: Analysis of the Tear Film Lipid Layer
The objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.
- Conditions
- Dry Eye Syndromes
- Being tested
- Tear Film Analyzer
- 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.
Tear Film AnalyzerDevice
Also called ocular surface interferometry
tear film images
| Study group | Role | What they receive |
|---|---|---|
| 1: Normal | Subjects without dry eye symptoms based on questionnaire. Receives: Device: Tear Film Analyzer | |
| 2: Dry Eye | Subjects with dry eye symptoms based on questionnaire. Receives: Device: Tear Film Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film analysis of lipid layer quality
Measured: upon enrollment
Secondary outcomes (5)
Dry Eye Symptoms
Measured: upon enrollment
Tear Film Break-Up Time
Measured: upon enrollment
Corneal and Conjunctival Staining
Measured: upon enrollment
Meibomian Gland Assessment
Measured: upon enrollment
Schirmer Test
Measured: upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- TearScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christy Stevens, OD, Study director, Kolis Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761917
- Sponsor's protocol ID
- KS010
- Status last verified
- Mar 2015
- First submitted
- 26 Sep 2008
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Tear Film Lipid Layer
- ClinicalTrials.gov ID
- NCT00761917
- Acronym / sponsor ID
- KS010
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- TearScience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Sep 2008 (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 objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Normal | – | Device: Tear Film AnalyzerSubjects without dry eye symptoms based on questionnaire. |
| 2: Dry Eye | – | Device: Tear Film AnalyzerSubjects with dry eye symptoms based on questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing routine eye examination in ophthalmic practices
Key inclusion criteria (2 listed)
- Adults 18 year of age or older
- Willing and able to comply with study exam procedure
Key exclusion criteria (9 listed)
- Eyelid abnormality or ocular surface condition affecting ability to visualize tear film
- Women who are pregnant or nursing
- Any of the following conditions within specified timeframe prior to study participation:
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 |
|---|---|---|
| Tear Film AnalyzerAlso: ocular surface interferometrytear film images | Device | 1: Normal, 2: Dry Eye |
Primary outcome
Tear film analysis of lipid layer quality
Time frame: upon enrollment
5 secondary outcomes
Dry Eye Symptoms
Time frame: upon enrollment
Tear Film Break-Up Time
Time frame: upon enrollment
Corneal and Conjunctival Staining
Time frame: upon enrollment
Meibomian Gland Assessment
Time frame: upon enrollment
Schirmer Test
Time frame: upon enrollment
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 31 Mar 2015.
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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.
Christy Stevens, OD study director
Kolis Scientific
8 sites 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 TearScience, Inc. at 8 sites 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 2 inclusion and 9 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Tear film analysis of lipid layer quality (time frame: upon enrollment). 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 31 Mar 2015.