Correlation of Different Signs for Assessment of Dry Eye Syndrome
NCT ID: NCT01753687
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-09-30
2013-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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50 patients with dry eye syndrome
Ocular scattering of the tear film
Optical Coherence Tomography (OCT)
Tear film thickness as measured with OCT
Measurement of tear film osmolarity
Interventions
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Ocular scattering of the tear film
Optical Coherence Tomography (OCT)
Tear film thickness as measured with OCT
Measurement of tear film osmolarity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Gerhard Garhofer
Assoc. Prof. PD Dr.
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Vienna, Austria
Countries
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References
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Schmidl D, Witkowska KJ, Kaya S, Baar C, Faatz H, Nepp J, Unterhuber A, Werkmeister RM, Garhofer G, Schmetterer L. The association between subjective and objective parameters for the assessment of dry-eye syndrome. Invest Ophthalmol Vis Sci. 2015 Feb 3;56(3):1467-72. doi: 10.1167/iovs.14-15814.
Other Identifiers
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OPHT-300511
Identifier Type: -
Identifier Source: org_study_id