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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01744457

Enrollment

Registered

2012-12-06

Start date

2011-02-28

Completion date

2012-06-30

Last updated

2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

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

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.

Interventions

DEVICEMeasurement of tear film osmolarity with the TearLab® instrument

OTHERSchirmer I test

OTHERTear break up time

DEVICEOptical Quality Analysis System

Measurement of the objective scattering index (OSI)

OTHEROcular Surface Disease Index

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026