<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02194361</url>
  </required_header>
  <id_info>
    <org_study_id>1147.3</org_study_id>
    <nct_id>NCT02194361</nct_id>
  </id_info>
  <brief_title>Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the Efficacy of Standardised Bilberry Extract in improving the night&#xD;
      vision and to evaluate its tolerability and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 1999</start_date>
  <primary_completion_date type="Actual">July 2000</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the dark adaption of the pupil using the method of the dark adaption Goggles (DAG)</measure>
    <time_frame>From day 1 to 28 and from day 57 to day 84</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of the dark adaption using dark flashes</measure>
    <time_frame>From day 1 to day 28 and from day 57 to day 84</time_frame>
    <description>Pupillography (PG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the weakest, correctly recognised contrast level</measure>
    <time_frame>From day 1 to day 28 and from day 57 to day 84</time_frame>
    <description>Mesoptometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of subjective efficacy based on a visual analogue scale (VAS) rating questionnaire</measure>
    <time_frame>pre-dose on day 1, day 28, pre-dose on day 57, day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of clinical global impression on a 5-point rating scale</measure>
    <time_frame>Days 28 and 84</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Anthocyan capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anthocyan capsules</intervention_name>
    <description>Bilberry extract capsules, 160 mg (25% anthocyanosides)</description>
    <arm_group_label>Anthocyan capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects (volunteers) with normal twilight and night vision&#xD;
&#xD;
          -  Age 18+, young and collaborative men or women&#xD;
&#xD;
          -  Having given their written informed consent&#xD;
&#xD;
          -  Full visual acuity (vision 0.8 or better) according to DIN Standard condition&#xD;
&#xD;
          -  Refraction ≤ +/-10.0 in the highest main step&#xD;
&#xD;
          -  Normal intraocular pressure (10-20 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Abnormal visual acuity or abnormal morphological eye findings&#xD;
&#xD;
          -  Glaucoma and macula degeneration&#xD;
&#xD;
          -  Disease of the retina&#xD;
&#xD;
          -  Consumption of anthocyan preparations during the past six months&#xD;
&#xD;
          -  Opthalmologic pathology: cataract, visus &lt; 0.8, retinal pathology, maculopathy,&#xD;
             intraocular pressure &gt; 21 mmHg, known acute or chronic eye disease, use of hard&#xD;
             contact lenses, eye surgery performed within the last 12 months&#xD;
&#xD;
          -  Any serious disorder that might interfere with his/her participation in this study and&#xD;
             the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus,&#xD;
             anamnestic indications of diabetic microangiopathy or polyneuropathy, renal&#xD;
             insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension&#xD;
             &gt; 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino&#xD;
&#xD;
          -  Any treatment that might interfere with the evaluation of the test drug, in particular&#xD;
             drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis,&#xD;
             ethambutol, chlorpromazine, benzodiazepines or phenothiazine derivatives such as&#xD;
             thioridazine, periciazine, perphenazine)&#xD;
&#xD;
          -  Known hypersensitivity to any of the ingredients of the study drug&#xD;
&#xD;
          -  Drug and alcohol abuse&#xD;
&#xD;
          -  Pregnancy, lactation, women of childbearing potential who do not use an established&#xD;
             contraceptive&#xD;
&#xD;
          -  Participation in another trial within the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02194361
org study id: 1147.3
nct id: NCT02194361
lead sponsor: 
Study to determine the Efficacy of Standardised Bilberry Extract in improving the night
      vision and to evaluate its tolerability and safety.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: 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
measure: Changes of the dark adaption using dark flashes
time frame: From day 1 to day 28 and from day 57 to day 84
description: Pupillography (PG)
measure: Changes of the weakest, correctly recognised contrast level
time frame: From day 1 to day 28 and from day 57 to day 84
description: Mesoptometry
measure: 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
measure: Assessment of clinical global impression on a 5-point rating scale
time frame: Days 28 and 84
arm group label: Anthocyan capsules
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Anthocyan capsules
description: Bilberry extract capsules, 160 mg (25% anthocyanosides)
arm group label: Anthocyan capsules
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor