Correlation of Different Signs for Assessment of Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

Correlation of Different Signs for Assessment of Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753687
• Other study ID #: OPHT-300511
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: November 26, 2013
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Other:
• Ocular scattering of the tear film

• Optical Coherence Tomography (OCT)
Tear film thickness as measured with OCT
• Measurement of tear film osmolarity

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Break up time	break up time of the tear film measured in seconds	once on the study day	No
Primary	Tear film thickness as measured with optical coherence tomography (OCT)	tear film thickness measured in micrometers	once on the study day	No
Secondary	Visual Acuity	Total number of letters read using ETDRS Charts	once on the study day	No
Secondary	Tear film osmolarity	Tear film osmolarity measured in mosmol/l	once on the study day	No
Secondary	OSI (Objective Scattering Index)	The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)	once on the study day	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Subjective symptoms of dry eye syndrome	a questionaire will be used	once on the study day	No