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Correlation of Different Signs for Assessment of Dry Eye Syndrome

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ClinicalTrials.gov Identifier: NCT01753687
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : November 27, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Correlation of Different Signs for Assessment of Dry Eye Syndrome
Study Start Date : September 2011
Primary Completion Date : July 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Break up time [ Time Frame: once on the study day ]
    break up time of the tear film measured in seconds

  2. Tear film thickness as measured with optical coherence tomography (OCT) [ Time Frame: once on the study day ]
    tear film thickness measured in micrometers

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: once on the study day ]
    Total number of letters read using ETDRS Charts

  2. Tear film osmolarity [ Time Frame: once on the study day ]
    Tear film osmolarity measured in mosmol/l

  3. OSI (Objective Scattering Index) [ Time Frame: once on the study day ]
    The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)

  4. Staining of the cornea with fluorescein [ Time Frame: once on the study day ]
    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.

  5. Impression cytology [ Time Frame: once on the study day ]
    After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.

  6. Tear cytokines/chemokines [ Time Frame: once on the study day ]
    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.

  7. Subjective symptoms of dry eye syndrome [ Time Frame: once on the study day ]
    a questionaire will be used

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753687

Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by Gerhard Garhofer, 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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases