Clinical trial NCT01753687: Correlation of Different Signs for Assessment of Dry Eye Syndrome
Official title: Correlation of Different Signs for Assessment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: break up time
tear film thickness
tear film osmolarity
objective scattering index
impression cytology
tear cytokines/chemokines
visual acuity
fluorescein staining
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Break up time
timeFrame: once on the study day
measure: Tear film thickness as measured with optical coherence tomography (OCT)
timeFrame: once on the study day
Secondary outcomes:
measure: Visual Acuity
timeFrame: once on the study day
measure: Tear film osmolarity
timeFrame: once on the study day
measure: OSI (Objective Scattering Index)
timeFrame: once on the study day
measure: Staining of the cornea with fluorescein
timeFrame: once on the study day
measure: Impression cytology
timeFrame: once on the study day
measure: Tear cytokines/chemokines
timeFrame: once on the study day
measure: Subjective symptoms of dry eye syndrome
timeFrame: once on the study day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
citation: 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.