Clinical trial NCT02194361: Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.


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

Primary outcomes:
measure: Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG)
timeFrame: From day 1 to 28 and from day 57 to day 84
Secondary outcomes:
measure: Changes of the dark adaption using dark flashes
timeFrame: From day 1 to day 28 and from day 57 to day 84
measure: Changes of the weakest, correctly recognised contrast level
timeFrame: From day 1 to day 28 and from day 57 to day 84
measure: Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire
timeFrame: pre-dose on day 1, day 28, pre-dose on day 57, day 84
measure: Assessment of clinical global impression on a 5-point rating scale
timeFrame: Days 28 and 84
Other outcomes:
Locations:
Study officials:
References: