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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Anthocyan capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194361

1147.3

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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119 participants in 2 patient groups, including a placebo group

Anthocyan capsules

Experimental group

Treatment:

Drug: Anthocyan capsules

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo