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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Measurement of tear film osmolarity with the TearLab® instrument
Schirmer I test
Tear break up time
Optical Quality Analysis System
Ocular Surface Disease Index
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye Syndrome focused on measuring tear film osmolarity, objective scattering index, tear break up time, Schirmer I test

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

20 patients with dry eye syndrome

20 healthy control subjects

Arm Description

Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria

age- and sex-matched controls

Outcomes

Primary Outcome Measures

Coefficient of variation of tear film osmolarity after repeated measurements

Secondary Outcome Measures

Subjective symptoms assessed using the OSDI test
Tear break up time
Schirmer I test
OSI (Objective Scattering Index)

Full Information

First Posted
December 5, 2012
Last Updated
December 5, 2012
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01744457
Brief Title
Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Official Title
Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
tear film osmolarity, objective scattering index, tear break up time, Schirmer I test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 patients with dry eye syndrome
Arm Type
Other
Arm Description
Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
Arm Title
20 healthy control subjects
Arm Type
Other
Arm Description
age- and sex-matched controls
Intervention Type
Device
Intervention Name(s)
Measurement of tear film osmolarity with the TearLab® instrument
Intervention Type
Other
Intervention Name(s)
Schirmer I test
Intervention Type
Other
Intervention Name(s)
Tear break up time
Intervention Type
Device
Intervention Name(s)
Optical Quality Analysis System
Intervention Description
Measurement of the objective scattering index (OSI)
Intervention Type
Other
Intervention Name(s)
Ocular Surface Disease Index
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Subjective symptoms assessed using the OSDI test
Time Frame
on the screening day
Title
Tear break up time
Time Frame
on 3 consecutive study days once a day
Title
Schirmer I test
Time Frame
on 3 consecutive study days once a day
Title
OSI (Objective Scattering Index)
Time Frame
on 3 consecutive study days once a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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