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OpenTrials
Completed

NCT Number: NCT02194361

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anthocyan capsules

Drug

Bilberry extract capsules, 160 mg (25% anthocyanosides)

Placebo

Drug

Primary outcomes

  1. Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG)

    Time frame: From day 1 to 28 and from day 57 to day 84

Secondary outcomes

  1. Changes of the dark adaption using dark flashes

    Time frame: From day 1 to day 28 and from day 57 to day 84

    Pupillography (PG)

  2. Changes of the weakest, correctly recognised contrast level

    Time frame: From day 1 to day 28 and from day 57 to day 84

    Mesoptometry

  3. Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire

    Time frame: pre-dose on day 1, day 28, pre-dose on day 57, day 84

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

    Time frame: Days 28 and 84

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Efficacy of a Bilberry Extract Standardised to a Content of 25% Anthocyanosides in Improving the Night Vision of Healthy Volunteers: a Double-blind, Randomized, Placebo Controlled, Cross-over Trial Over 2 x 28 Days

Important dates

Study start
1999
Primary completion
2000
First posted
Jul 18, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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