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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Anthocyan capsules; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194127

1147.2

Details and patient eligibility

About

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

Enrollment: 195 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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195 participants in 2 patient groups, including a placebo group

Anthocyan capsules

Experimental group

Description:

capsules containing 160 mg standardised bilberry extract (25% anthocyanidines)

Treatment:

Drug: Anthocyan capsules

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo