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

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ClinicalTrials.gov Identifier: NCT02194361
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Anthocyan capsules Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : December 1999
Actual Primary Completion Date : July 2000


Arm Intervention/treatment
Experimental: Anthocyan capsules Drug: Anthocyan capsules
Bilberry extract capsules, 160 mg (25% anthocyanosides)

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02194361    
Other Study ID Numbers: 1147.3
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014