Healthy
Conditions
Brief summary
Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.
Interventions
Bilberry extract capsules, 160 mg (25% anthocyanosides)
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects (volunteers) with normal twilight and night vision * Age 18+, young and collaborative men or women * Having given their written informed consent * Full visual acuity (vision 0.8 or better) according to DIN Standard condition * Refraction ≤ +/-10.0 in the highest main step * Normal intraocular pressure (10-20 mmHg)
Exclusion criteria
* Diabetes mellitus * Epilepsy * Abnormal visual acuity or abnormal morphological eye findings * Glaucoma and macula degeneration * Disease of the retina * Consumption of anthocyan preparations during the past six months * Opthalmologic pathology: cataract, visus \< 0.8, retinal pathology, maculopathy, intraocular pressure \> 21 mmHg, known acute or chronic eye disease, use of hard contact lenses, eye surgery performed within the last 12 months * Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus, anamnestic indications of diabetic microangiopathy or polyneuropathy, renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension \> 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino * Any treatment that might interfere with the evaluation of the test drug, in particular drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis, ethambutol, chlorpromazine, benzodiazepines or phenothiazine derivatives such as thioridazine, periciazine, perphenazine) * Known hypersensitivity to any of the ingredients of the study drug * Drug and alcohol abuse * Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive * Participation in another trial within the past 30 days
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the dark adaption using dark flashes | From day 1 to day 28 and from day 57 to day 84 | Pupillography (PG) |
| Changes of the weakest, correctly recognised contrast level | From day 1 to day 28 and from day 57 to day 84 | Mesoptometry |
| 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 | — |
Outcome results
None listed