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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Other: Ocular scattering of the tear film; Other: Optical Coherence Tomography (OCT); Other: Measurement of tear film osmolarity

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 50 patients with dry eye syndrome	Other: Ocular scattering of the tear film; Other Names: OQAS, Visometrics, Spain; Other: Optical Coherence Tomography (OCT); Tear film thickness as measured with OCT; Other: Measurement of tear film osmolarity; Other Names: TearLab®, OcuSens Inc, San Diego, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Break up time	break up time of the tear film measured in seconds	once on the study day
Tear film thickness as measured with optical coherence tomography (OCT)	tear film thickness measured in micrometers	once on the study day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Total number of letters read using ETDRS Charts	once on the study day
Tear film osmolarity	Tear film osmolarity measured in mosmol/l	once on the study day
OSI (Objective Scattering Index)	The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)	once on the study day
Staining of the cornea with fluorescein	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.	once on the study day
Impression cytology	After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.	once on the study day
Tear cytokines/chemokines	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.	once on the study day
Subjective symptoms of dry eye syndrome	a questionaire will be used	once on the study day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: impression cytology; visual acuity; fluorescein staining; tear film thickness; break up time; tear film osmolarity; objective scattering index; tear cytokines/chemokines
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: OPHT-300511