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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.
Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with dry eye syndrome 1 | Experimental | 20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2 |
|
| Patients with dry eye syndrome 2 | Experimental | 20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo Gel and Thealoz Duo eye drops | Device | Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction when awakening (VAS) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 4 weeks | |
| Number of drops of Thealoz Duo instilled during the day (patient diary) | 4 weeks | |
| Tear break up time |
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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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|
| Thealoz Duo eye drops | Device | Thealoz Duo eye drops during the day (4 to 6 drops per day) |
|
|
| 4 weeks |
| Conjunctival and corneal staining | 4 weeks |
| Schirmer 1 Test | 4 weeks |
| OSDI questionnaire | Ocular Surface Disease Index Questionnaire | 4 weeks |