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Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about the tear film thickness and the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.
Recently a new method for assessment of tear film thickness based on ultra high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with dry eye syndrome 1 | Experimental | 20 Patients with dry eye syndrome |
|
| Patients with dry eye syndrome 2 | Active Comparator | 20 Patients with dry eye syndrome |
|
| Patients with dry eye syndrome 3 | Active Comparator | 20 Patients with dry eye syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo Gel | Device | Manufacturer: Laboratoires Thea, France |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film thickness as measured with optical coherence tomography (OCT) | 360 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time | 1 month | |
| Schirmer 1 test | 1 month | |
| Subjective evaluation of ocular comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Hylo-Gel |
| Device |
Manufacturer: Ursapharm, Saarbrücken, Germany |
|
| Systane Gel Drops | Device | Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA |
|
| 1 month |