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Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthocyan capsules | Experimental | capsules containing 160 mg standardised bilberry extract (25% anthocyanidines) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyan capsules | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the maximum velocity of dilatation of the pupil | day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the maximum velocity of dilatation of the pupil | Days 1 and 8 | |
| Measurement of the initial pupil diameter | days 1, 8 and 29 | |
| Measurement of the latency time |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Days 1, 8 and 29 |
| Measurement of the absolute and relative constriction amplitude | Days 1, 8 and 29 |
| Measurement of maximum velocity of contraction | Days 1, 8 and 29 |
| Measurement of velocity of contraction 2 | Days 1, 8 and 29 |
| Measurement of initial minimal contrast level | Determined with Gecko Contrast card | Days 1, 8 and 29 |
| Time to regain contrast vision at one level above the initial minimal contrast | Determined with Gecko Contrast card | days 1, 8 and 29 |
| Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare | determined with Mesoptometer II | Days 1, 8 and 29 |
| Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare | determined with Mesoptometer II | Days 1, 8 and 29 |
| Recovery time after dazzling | Days 1, 8 and 29 |
| Change of potential (µVolt) in retina due to photo activation | Measured with Standard Electroretinography (ERG) | Baseline, days 1, 8 and 29 |
| Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire | Pre-dose and days 1, 8 and 29 |
| Assessment of clinical global impression on a 5-point rating scale | Day 29 |
| Number of patients with adverse events | up to day 29 |
| Number of patients with significant changes in laboratory parameters | Baseline and day 29 |