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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01753687
Other study ID # OPHT-300511
Secondary ID
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


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
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