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

Phase 2

Completed

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

• Registration Number: NCT02194361
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2000-07
• Status Verified: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-18
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Anthocyan capsules	Anthocyan capsules	-

Primary Outcome Measures

Name	Time	Method
Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG)	From day 1 to 28 and from day 57 to day 84

Secondary Outcome Measures

Name	Time	Method
Assessment of clinical global impression on a 5-point rating scale	Days 28 and 84
Changes of the dark adaption using dark flashes	From day 1 to day 28 and from day 57 to day 84	Pupillography (PG)
Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire	pre-dose on day 1, day 28, pre-dose on day 57, day 84
Changes of the weakest, correctly recognised contrast level	From day 1 to day 28 and from day 57 to day 84	Mesoptometry