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

NCT ID: NCT01744457

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Dry Eye Syndrome

Keywords

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tear film osmolarity objective scattering index tear break up time Schirmer I test

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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20 patients with dry eye syndrome

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

Group Type OTHER

Measurement of tear film osmolarity with the TearLab® instrument

Intervention Type DEVICE

Schirmer I test

Intervention Type OTHER

Tear break up time

Intervention Type OTHER

Optical Quality Analysis System

Intervention Type DEVICE

Measurement of the objective scattering index (OSI)

Ocular Surface Disease Index

Intervention Type OTHER

20 healthy control subjects

age- and sex-matched controls

Group Type OTHER

Measurement of tear film osmolarity with the TearLab® instrument

Intervention Type DEVICE

Schirmer I test

Intervention Type OTHER

Tear break up time

Intervention Type OTHER

Optical Quality Analysis System

Intervention Type DEVICE

Measurement of the objective scattering index (OSI)

Ocular Surface Disease Index

Intervention Type OTHER

Interventions

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Measurement of tear film osmolarity with the TearLab® instrument

Intervention Type DEVICE

Schirmer I test

Intervention Type OTHER

Tear break up time

Intervention Type OTHER

Optical Quality Analysis System

Measurement of the objective scattering index (OSI)

Intervention Type DEVICE

Ocular Surface Disease Index

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-161009

Identifier Type: -

Identifier Source: org_study_id