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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, information about 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 optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate 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 |
|---|---|---|---|
| Dry Eye Syndrome I | Experimental | 20 patients with moderate dry eye syndrome |
|
| Dry Eye Syndrome II | Active Comparator | 20 patients with moderate dry eye syndrome |
|
| Dry Eye Syndrome III | Active Comparator | 20 patients with moderate dry eye syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo® | Device | Eye Drops |
| |
| Hyabak® |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film thickness | Change in tear film thickness as measured with OCT. Total time frame is 4 hours | Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time | Total time frame is 14 days | change from screening to the last OCT measurement |
| Subjective evaluation of ocular comfort | Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Garhoefer, MD | Department of Clinical Pharmacology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology | Vienna | State of 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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| Device |
Eye Drops |
|
| Hydrabak® | Device | Eye Drops |
|
| change after instillation and after the last OCT measurement |
| Schirmer I test | Total time frame is 14 days | change from screening to after the last OCT measurement |
| Visual Acuity | Total time frame is 14 days. | change from screening to after the last OCT measurement |
| Intraocular Pressure | Total time frame is 14 days | change from screening to after the last OCT measurement |