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

NCT02194361 | Completed Phase 2

• 1 other identifier: 1147.3
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes of the dark adaption using dark flashes

  From day 1 to day 28 and from day 57 to day 84

• Changes of the weakest, correctly recognised contrast level

  From day 1 to day 28 and from day 57 to day 84

• 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

• Assessment of clinical global impression on a 5-point rating scale

  Days 28 and 84

Study Arms (2)

Anthocyan capsules

EXPERIMENTAL

Drug: Anthocyan capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Anthocyan capsules DRUG

Bilberry extract capsules, 160 mg (25% anthocyanosides)

Anthocyan capsules

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: December 1, 1999
• Primary Completion: July 1, 2000
• Last Updated: July 18, 2014

Record last verified: 2014-07