Healthy
Conditions
Brief summary
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.
Interventions
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects (volunteers) with age-related impaired twilight and night * Age 50 to 70, men or women * Written informed consent * Full visual acuity (vision ≥ 0.7) according to DIN Standard condition * Refraction ≤ +/-6.0 in the highest main step * Age-related findings in the ophthalmologic examination (anterior chamber and eye ground) * Normal intraocular pressure (10-20 mmHg)
Exclusion criteria
* Diabetes mellitus * Epilepsy * Abnormal visual acuity or eye ground (e.g. clouding of the lens) * Age related vision problems * Glaucoma and macular degeneration * Disease of the retina * Consumption of anthocyan preparations during the past six months * Opthalmologic pathology: cataract, visus \< 0.7, 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 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 |
|---|---|
| Measurement of the maximum velocity of dilatation of the pupil | day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the initial pupil diameter | days 1, 8 and 29 | — |
| Measurement of the latency time | 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 | Days 1, 8 and 29 | Determined with Gecko Contrast card |
| Time to regain contrast vision at one level above the initial minimal contrast | days 1, 8 and 29 | Determined with Gecko Contrast card |
| Measurement of the maximum velocity of dilatation of the pupil | Days 1 and 8 | — |
| Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare | Days 1, 8 and 29 | determined with Mesoptometer II |
| Recovery time after dazzling | Days 1, 8 and 29 | — |
| Change of potential (µVolt) in retina due to photo activation | Baseline, days 1, 8 and 29 | Measured with Standard Electroretinography (ERG) |
| 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 | — |
| Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare | Days 1, 8 and 29 | determined with Mesoptometer II |
Outcome results
None listed