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

December 5, 2012 updated by: Gerhard Garhofer, Medical University of Vienna

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective symptoms assessed using the OSDI test
Time Frame: on the screening day
on the screening day
Tear break up time
Time Frame: on 3 consecutive study days once a day
on 3 consecutive study days once a day
Schirmer I test
Time Frame: on 3 consecutive study days once a day
on 3 consecutive study days once a day
OSI (Objective Scattering Index)
Time Frame: on 3 consecutive study days once a day
on 3 consecutive study days once a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-161009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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