Correlation of Different Signs for Assessment of Dry Eye Syndrome

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: Ocular scattering of the tear film; Other: Optical Coherence Tomography (OCT); Other: Measurement of tear film osmolarity

• Registration Number: NCT01753687
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50 patients with dry eye syndrome	Ocular scattering of the tear film	-
50 patients with dry eye syndrome	Optical Coherence Tomography (OCT)	-
50 patients with dry eye syndrome	Measurement of tear film osmolarity	-

Primary Outcome Measures

Name	Time	Method
Break up time	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)	once on the study day	tear film thickness measured in micrometers

Secondary Outcome Measures

Name	Time	Method
Subjective symptoms of dry eye syndrome	once on the study day	a questionaire will be used
Visual Acuity	once on the study day	Total number of letters read using ETDRS Charts
Tear film osmolarity	once on the study day	Tear film osmolarity measured in mosmol/l
OSI (Objective Scattering Index)	once on the study day	The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)
Staining of the cornea with fluorescein	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	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	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.

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria