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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744457
• Other study ID #: OPHT-161009
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 5, 2012
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Healthcare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• Measurement of tear film osmolarity with the TearLab® instrument

Other:
• Schirmer I test

• Tear break up time

Device:
• Optical Quality Analysis System
Measurement of the objective scattering index (OSI)

Other:
• Ocular Surface Disease Index

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subjective symptoms assessed using the OSDI test		on the screening day	No
Secondary	Tear break up time		on 3 consecutive study days once a day	No
Secondary	Schirmer I test		on 3 consecutive study days once a day	No
Secondary	OSI (Objective Scattering Index)		on 3 consecutive study days once a day	No