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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: 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

• Registration Number: NCT01744457
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Last Update Submitted: 2012-12-05
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Read More

Exclusion Criteria

• Abuse of drugs or alcoholic beverages
• Participation in a clinical trial
• Symptoms of a clinically relevant illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 patients with dry eye syndrome	Measurement of tear film osmolarity with the TearLab® instrument	Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
20 patients with dry eye syndrome	Schirmer I test	Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
20 healthy control subjects	Ocular Surface Disease Index	age- and sex-matched controls
20 patients with dry eye syndrome	Tear break up time	Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
20 patients with dry eye syndrome	Optical Quality Analysis System	Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
20 patients with dry eye syndrome	Ocular Surface Disease Index	Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria
20 healthy control subjects	Measurement of tear film osmolarity with the TearLab® instrument	age- and sex-matched controls
20 healthy control subjects	Schirmer I test	age- and sex-matched controls
20 healthy control subjects	Tear break up time	age- and sex-matched controls
20 healthy control subjects	Optical Quality Analysis System	age- and sex-matched controls

Primary Outcome Measures

Name	Time	Method
Coefficient of variation of tear film osmolarity after repeated measurements	Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria