NCT01744457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 5, 2012

Last Update Submit

December 5, 2012

Conditions

Dry Eye Syndrome

Keywords

tear film osmolarityobjective scattering indextear break up timeSchirmer I test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

20 patients with dry eye syndrome

OTHER

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

Device: Measurement of tear film osmolarity with the TearLab® instrumentOther: Schirmer I testOther: Tear break up timeDevice: Optical Quality Analysis SystemOther: Ocular Surface Disease Index

20 healthy control subjects

OTHER

age- and sex-matched controls

Device: Measurement of tear film osmolarity with the TearLab® instrumentOther: Schirmer I testOther: Tear break up timeDevice: Optical Quality Analysis SystemOther: Ocular Surface Disease Index

Interventions

Measurement of tear film osmolarity with the TearLab® instrumentDEVICE
20 healthy control subjects20 patients with dry eye syndrome
Schirmer I testOTHER
20 healthy control subjects20 patients with dry eye syndrome
Tear break up timeOTHER
20 healthy control subjects20 patients with dry eye syndrome
Optical Quality Analysis SystemDEVICE

Measurement of the objective scattering index (OSI)

20 healthy control subjects20 patients with dry eye syndrome
Ocular Surface Disease IndexOTHER
20 healthy control subjects20 patients with dry eye syndrome

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 6, 2012

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

AU(1)