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Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.
For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy subjects I | Experimental | 20 healthy subjects |
|
| healthy subjects II | Experimental | 20 healthy subjects |
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| healthy subjects III | Experimental | 20 healthy subjects |
|
| healthy subjects IV | Experimental | 20 healthy subjects |
|
| healthy subjects V | Experimental | 20 healthy subjects |
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| healthy subjects VI | No Intervention | 20 healthy subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timoptic® 0.5% | Drug | Timoptic® 0.5% Eye Drops, Merck, single instillation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film thickness | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Break up time (BUT) | once on the study day |
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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 | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23847319 | Derived | Werkmeister RM, Alex A, Kaya S, Unterhuber A, Hofer B, Riedl J, Bronhagl M, Vietauer M, Schmidl D, Schmoll T, Garhofer G, Drexler W, Leitgeb RA, Groeschl M, Schmetterer L. Measurement of tear film thickness using ultrahigh-resolution optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Aug 15;54(8):5578-83. doi: 10.1167/iovs.13-11920. |
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| Timophtal sine® 0.5% |
| Drug |
Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation |
|
| Genteal HA® | Device | Genteal HA® Eye Drops, Novartis, single instillation |
|
| Hylo-Comod® | Device | Hylo-Comod® Eye Drops, Croma-Pharma, single instillation |
|
| Thealoz® | Device | Thealoz® Eye Drops, Thea, France, single instillation |
|