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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Anthocyan capsules; Drug: Placebo

• Registration Number: NCT02194127
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Primary Completion: 1999-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anthocyan capsules	Anthocyan capsules	capsules containing 160 mg standardised bilberry extract (25% anthocyanidines)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Measurement of the maximum velocity of dilatation of the pupil	day 29

Secondary Outcome Measures

Name	Time	Method
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	Days 1, 8 and 29	Determined with Gecko Contrast card
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
Time to regain contrast vision at one level above the initial minimal contrast	days 1, 8 and 29	Determined with Gecko Contrast card
Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare	Days 1, 8 and 29	determined with Mesoptometer II
Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare	Days 1, 8 and 29	determined with Mesoptometer II
Recovery time after dazzling	Days 1, 8 and 29
Change of potential (µVolt) in retina due to photo activation	Baseline, days 1, 8 and 29	Measured with Standard Electroretinography (ERG)
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