Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Completed
NCT Number: NCT01753687
Correlation of Different Signs for Assessment of Dry Eye Syndrome
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Ocular scattering of the tear film
OtherOther names: OQAS, Visometrics, Spain
Optical Coherence Tomography (OCT)
OtherTear film thickness as measured with OCT
Measurement of tear film osmolarity
OtherOther names: TearLab®, OcuSens Inc, San Diego, USA
Primary outcomes
-
Break up time
Time frame: once on the study day
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
tear film thickness measured in micrometers
Secondary outcomes
-
Visual Acuity
Time frame: once on the study day
Total number of letters read using ETDRS Charts
-
Tear film osmolarity
Time frame: once on the study day
Tear film osmolarity measured in mosmol/l
-
OSI (Objective Scattering Index)
Time frame: once on the study day
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
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
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
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
a questionaire will be used
Sponsors and collaborators
Lead sponsor
Medical University of Vienna
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Dec 20, 2012
- Registry last updated
- Nov 27, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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