Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision

Study Overview
=================
Brief Summary
-----------------
Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.

Official Title
-----------------
Efficacy and Tolerability of a Treatment Over 28 Days With a Bilberry Extract Standardised to a Content of 25% Anthocyanidines in Volunteers With Impaired Twilight and Night Vision

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Anthocyan capsules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anthocyan capsules<br>capsules containing 160 mg standardised bilberry extract (25% anthocyanidines) | Drug: Anthocyan capsules<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the maximum velocity of dilatation of the pupil |  | day 29 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |