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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 influence on tear film thickness and 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 the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® 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, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Patients with dry eye syndrome 1 | Experimental | 40 Patients with dry eye syndrome |
|
| Experimental: Patients with dry eye syndrome 2 | Active Comparator | 40 Patients with dry eye syndrome |
|
| Experimental: Patients with dry eye syndrome 3 | Active Comparator | 40 Patients with dry eye syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo Eye Drops | Device | Manufacturer: Laboratoires Thea, France |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in tear film thickness as measured with Optical Coherence Tomography (OCT) | Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day | 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time (BUT) | 10 weeks | |
| Subjective evaluation of ocular comfort with questionnaire | 10 weeks | |
| Schirmer I test |
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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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| Optive Eye Drops | Device | Manufacturer: Allergan Pharmaceuticals, Ireland |
|
| Systane Ultra Eye Drops | Device | Manufacturer: Alcon Pharma GmbH |
|
| 10 weeks |
| OSDI score | 10 weeks |
| Corneal fluorescein staining (Oxford grading scale) | 10 weeks |
| Conjunctival hyperemia score | 10 weeks |
| Efficacy assessment of eye drops by the patient with questionnaire | Efficacy of eye drops will be performed by the patient by choosing one of the following options:
| 10 weeks |
| Efficacy assessment of eye drops by the investigator with questionnaire | Efficacy of eye drops will be performed by the investigator by choosing one of the following options:
| 10 weeks |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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