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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005423-16 | EudraCT Number |
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This study is intended to investigate the tolerability and the safety of Cyclosporine A containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo (vehicle) in the first part (first period) of the study, and switched to the alternative dosing in the second part (second period) of the study. An ophthalmological assessment of the eyes will be performed, and a questionnaire will be issued in the beginning and after each dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyclASol® | Experimental | CyclASol® |
|
| Placebo | Placebo Comparator | Placebo (vehicle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyclASol® | Drug | Cyclosporine A Solution |
| |
| Placebo (vehicle) |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability measured by the rate and severity of drug-related adverse events of the eyes | Multiple ophthalmologic assessments are performed in order to determine adverse effects of the investigational medicinal product on structures of the eye and its physiology. | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Beckert, MD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neu-Ulm | 89231 | Germany |
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| Drug |
Vehicle Solution |
|