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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Official Title  ICMJE Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Dry Eye Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 20 patients with dry eye syndrome
    Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
    Interventions:
    • 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
    age- and sex-matched controls
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2012)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744457
Other Study ID Numbers  ICMJE OPHT-161009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP