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

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

Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision and to test its tolerability and safety.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Primary Completion (Actual): June 1, 1999

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 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1147.2