Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01744457
First received: December 5, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective symptoms assessed using the OSDI test [ Time Frame: on the screening day ] [ Designated as safety issue: No ]
  • Tear break up time [ Time Frame: on 3 consecutive study days once a day ] [ Designated as safety issue: No ]
  • Schirmer I test [ Time Frame: on 3 consecutive study days once a day ] [ Designated as safety issue: No ]
  • OSI (Objective Scattering Index) [ Time Frame: on 3 consecutive study days once a day ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744457

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

No publications provided

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
Study First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: Austria: Austrian Federal Office for Safety in Healthcare

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

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

ClinicalTrials.gov processed this record on June 18, 2013