Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.

Official Title
-----------------
Efficacy of a Bilberry Extract Standardised to a Content of 25% Anthocyanosides in Improving the Night Vision of Healthy Volunteers: a Double-blind, Randomized, Placebo Controlled, Cross-over Trial Over 2 x 28 Days

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

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


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

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anthocyan capsules<br> | Drug: Anthocyan capsules<br>* Bilberry extract capsules, 160 mg (25% anthocyanosides)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |