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Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthocyan capsules | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyan capsules | Drug | Bilberry extract capsules, 160 mg (25% anthocyanosides) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG) | From day 1 to 28 and from day 57 to day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the dark adaption using dark flashes | Pupillography (PG) | From day 1 to day 28 and from day 57 to day 84 |
| Changes of the weakest, correctly recognised contrast level | Mesoptometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo |
| Drug |
|
| From day 1 to day 28 and from day 57 to day 84 |
| Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire | pre-dose on day 1, day 28, pre-dose on day 57, day 84 |
| Assessment of clinical global impression on a 5-point rating scale | Days 28 and 84 |