Clinical trial NCT02194127: Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 195
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the maximum velocity of dilatation of the pupil
timeFrame: day 29
Secondary outcomes:
measure: Measurement of the maximum velocity of dilatation of the pupil
timeFrame: Days 1 and 8
measure: Measurement of the initial pupil diameter
timeFrame: days 1, 8 and 29
measure: Measurement of the latency time
timeFrame: Days 1, 8 and 29
measure: Measurement of the absolute and relative constriction amplitude
timeFrame: Days 1, 8 and 29
measure: Measurement of maximum velocity of contraction
timeFrame: Days 1, 8 and 29
measure: Measurement of velocity of contraction 2
timeFrame: Days 1, 8 and 29
measure: Measurement of initial minimal contrast level
timeFrame: Days 1, 8 and 29
measure: Time to regain contrast vision at one level above the initial minimal contrast
timeFrame: days 1, 8 and 29
measure: Measurement of contrast threshold level at illumination 0.1 cd/m2 with glare
timeFrame: Days 1, 8 and 29
measure: Measurement of contrast threshold level at illumination 0.032 cd/m2 without glare
timeFrame: Days 1, 8 and 29
measure: Recovery time after dazzling
timeFrame: Days 1, 8 and 29
measure: Change of potential (µVolt) in retina due to photo activation
timeFrame: Baseline, days 1, 8 and 29
measure: Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire
timeFrame: Pre-dose and days 1, 8 and 29
measure: Assessment of clinical global impression on a 5-point rating scale
timeFrame: Day 29
measure: Number of patients with adverse events
timeFrame: up to day 29
measure: Number of patients with significant changes in laboratory parameters
timeFrame: Baseline and day 29
Other outcomes:
Locations:
Study officials:
References: