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Correlation of Different Signs for Assessment of Dry Eye Syndrome

This study is currently recruiting participants.
Verified December 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01753687
First received: December 7, 2012
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.

The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.


Condition Intervention
Dry Eye Syndrome
 Other: Ocular scattering of the tear film
Other: Optical Coherence Tomography (OCT)
Other: Measurement of tear film osmolarity

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Correlation of Different Signs for Assessment of Dry Eye Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Break up time [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    break up time of the tear film measured in seconds

  • Tear film thickness as measured with optical coherence tomography (OCT) [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    tear film thickness measured in micrometers


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    Total number of letters read using ETDRS Charts

  • Tear film osmolarity [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    Tear film osmolarity measured in mosmol/l

  • OSI (Objective Scattering Index) [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)

  • Staining of the cornea with fluorescein [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study.

  • Impression cytology [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.

  • Tear cytokines/chemokines [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated.

  • Subjective symptoms of dry eye syndrome [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
    a questionaire will be used


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
50 patients with dry eye syndrome Other: Ocular scattering of the tear film
Other Name: OQAS, Visometrics, Spain
Other: Optical Coherence Tomography (OCT)
Tear film thickness as measured with OCT
Other: Measurement of tear film osmolarity
Other Name: TearLab®, OcuSens Inc, San Diego, USA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged over 18 years
  • History of dry eye syndrome for at least 3 months
  • At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds
  • Normal ophthalmic findings except dry eye syndrome

Exclusion Criteria:

  • Participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
  • Wearing of contact lenses
  • Intake of dietary supplements in the 3 months preceding the study
  • Glaucoma
  • Treatment with corticosteroids in the 4 weeks preceding the study
  • Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
  • Ocular infection or clinically significant inflammation
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • Pregnancy, planned pregnancy or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753687

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD     +43140400 ext 2981     gerhard.garhoefer@meduniwien.ac.at    
Principal Investigator: Gerhard Garhoefer, MD            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01753687     History of Changes
Other Study ID Numbers: OPHT-300511
Study First Received: December 7, 2012
Last Updated: December 17, 2012
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
break up time
tear film thickness
tear film osmolarity
objective scattering index
 impression cytology
tear cytokines/chemokines
visual acuity
fluorescein staining

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on June 18, 2013