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Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01744457
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Study Start Date : February 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
20 patients with dry eye syndrome
Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
Device: Measurement of tear film osmolarity with the TearLab® instrument
Other: Schirmer I test
Other: Tear break up time
Device: Optical Quality Analysis System
Measurement of the objective scattering index (OSI)

Other: Ocular Surface Disease Index
20 healthy control subjects
age- and sex-matched controls
Device: Measurement of tear film osmolarity with the TearLab® instrument
Other: Schirmer I test
Other: Tear break up time
Device: Optical Quality Analysis System
Measurement of the objective scattering index (OSI)

Other: Ocular Surface Disease Index



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Subjective symptoms assessed using the OSDI test [ Time Frame: on the screening day ]
  2. Tear break up time [ Time Frame: on 3 consecutive study days once a day ]
  3. Schirmer I test [ Time Frame: on 3 consecutive study days once a day ]
  4. OSI (Objective Scattering Index) [ Time Frame: on 3 consecutive study days once a day ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Abuse of drugs or alcoholic beverages
  • Participation in a clinical trial
  • Symptoms of a clinically relevant illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744457


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01744457     History of Changes
Other Study ID Numbers: OPHT-161009
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
tear film osmolarity
objective scattering index
tear break up time
Schirmer I test

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases