Dry Eye SyndromeNCT01744457
Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
A study testing Measurement of tear film osmolarity with the TearLab® instrument, Schirmer I test and Tear break up time in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Measurement of tear film osmolarity with the TearLab® instrument, Schirmer I test and Tear break up time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2011to Jun 2012
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with dry eye syndrome (DES):
- Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
- normal findings in the ophthalmic examination other than DES
- Healthy control group:
- Men and Women aged between 45 and 80 years,
- normal findings in the medical history and ophthalmic examination
Who cannot join
- Abuse of drugs or alcoholic beverages
- Participation in a clinical trial
- Symptoms of a clinically relevant illness
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.
Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.
- Conditions
- Dry Eye Syndrome
- Being tested
- Measurement of tear film osmolarity with the TearLab® instrument, Schirmer I test, Tear break up time, Optical Quality Analysis System, Ocular Surface Disease Index
- Keywords
- tear film osmolarity, objective scattering index, tear break up time, Schirmer I test
- 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.
Measurement of tear film osmolarity with the TearLab® instrumentDevice
Schirmer I testOther
Tear break up timeOther
Optical Quality Analysis SystemDevice
Measurement of the objective scattering index (OSI)
Ocular Surface Disease IndexOther
| Study group | Role | What they receive |
|---|---|---|
| 20 patients with dry eye syndrome | Other | Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria Receives: Device: Measurement of tear film osmolarity with the TearLab® instrument; Other: Schirmer I test; Other: Tear break up time; Device: Optical Quality Analysis System; Other: Ocular Surface Disease Index |
| 20 healthy control subjects | Other | age- and sex-matched controls Receives: Device: Measurement of tear film osmolarity with the TearLab® instrument; Other: Schirmer I test; Other: Tear break up time; Device: Optical Quality Analysis System; Other: Ocular Surface Disease Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation of tear film osmolarity after repeated measurements
Measured: Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days
Secondary outcomes (4)
Subjective symptoms assessed using the OSDI test
Measured: on the screening day
Tear break up time
Measured: on 3 consecutive study days once a day
Schirmer I test
Measured: on 3 consecutive study days once a day
OSI (Objective Scattering Index)
Measured: on 3 consecutive study days once a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744457
- Sponsor's protocol ID
- OPHT-161009
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01744457
- Acronym / sponsor ID
- OPHT-161009
- Conditions
- Dry Eye Syndrome
- Keywords
- tear film osmolarity, objective scattering index, tear break up time, Schirmer I test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Dec 2012 (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.
Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.
Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 patients with dry eye syndrome | Other | Device: Measurement of tear film osmolarity with the TearLab® instrument, Other: Schirmer I test, Other: Tear break up time, Device: Optical Quality Analysis System, Other: Ocular Surface Disease IndexPatients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria |
| 20 healthy control subjects | Other | Device: Measurement of tear film osmolarity with the TearLab® instrument, Other: Schirmer I test, Other: Tear break up time, Device: Optical Quality Analysis System, Other: Ocular Surface Disease Indexage- and sex-matched controls |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
- normal findings in the ophthalmic examination other than DES
- Men and Women aged between 45 and 80 years,
- normal findings in the medical history and ophthalmic examination
Key exclusion criteria (3 listed)
- Abuse of drugs or alcoholic beverages
- Participation in a clinical trial
- Symptoms of a clinically relevant illness
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 |
|---|---|---|
| Measurement of tear film osmolarity with the TearLab® instrument | Device | 20 healthy control subjects, 20 patients with dry eye syndrome |
| Schirmer I test | Other | 20 healthy control subjects, 20 patients with dry eye syndrome |
| Tear break up time | Other | 20 healthy control subjects, 20 patients with dry eye syndrome |
| Optical Quality Analysis SystemMeasurement of the objective scattering index (OSI) | Device | 20 healthy control subjects, 20 patients with dry eye syndrome |
| Ocular Surface Disease Index | Other | 20 healthy control subjects, 20 patients with dry eye syndrome |
Primary outcome
Coefficient of variation of tear film osmolarity after repeated measurements
Time frame: Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days
4 secondary outcomes
Subjective symptoms assessed using the OSDI test
Time frame: on the screening day
Tear break up time
Time frame: on 3 consecutive study days once a day
Schirmer I test
Time frame: on 3 consecutive study days once a day
OSI (Objective Scattering Index)
Time frame: on 3 consecutive study days once a day
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 6 Dec 2012.
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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?
A study testing Measurement of tear film osmolarity with the TearLab® instrument, Schirmer I test and Tear break up time in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 3 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 6 Dec 2012. 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 Austria. 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?
Coefficient of variation of tear film osmolarity after repeated measurements (time frame: Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days). 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 6 Dec 2012.