Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.
Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 healthy subjects | Experimental | Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo |
|
| 30 patients with dry eye syndrome | Experimental | Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) | Device |
| ||
| Physiological Sodium Chloride solution (0,9%) |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film thickness | change from baseline to 1 hour after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer I Test | once on the study day | 1 day |
| Tear Break Up Time | once on the study day | 1 day |
Not provided
Inclusion Criteria:
Inclusion criteria for healthy subjects:
Inclusion criteria for patients with dry eye syndrome:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Placebo |
|
| Ocular Surface Disease Index | once on the study day | 1 day |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided