Skip to main content
OpenTrials
Completed

NCT Number: NCT01744457

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of tear film osmolarity with the TearLab® instrument

Device

Schirmer I test

Other

Tear break up time

Other

Optical Quality Analysis System

Device

Measurement of the objective scattering index (OSI)

Ocular Surface Disease Index

Other

Primary outcomes

  1. 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 outcomes

  1. Subjective symptoms assessed using the OSDI test

    Time frame: on the screening day

  2. Tear break up time

    Time frame: on 3 consecutive study days once a day

  3. Schirmer I test

    Time frame: on 3 consecutive study days once a day

  4. OSI (Objective Scattering Index)

    Time frame: on 3 consecutive study days once a day

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 6, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.