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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Anthocyan capsules

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Anthocyan capsules	Drug: Anthocyan capsules; Bilberry extract capsules, 160 mg (25% anthocyanosides)

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): July 1, 2000

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1147.3