xml: <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/NCT06004570</url>
    </required_header>
    <id_info>
      <org_study_id>05-AP-RET</org_study_id>
      <nct_id>NCT06004570</nct_id>
    </id_info>
    <brief_title>Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases</brief_title>
    <official_title>Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to confirm that daily supplementation with a product containing a&#xD;
        standardized combination of polyphenol-rich extracts has a protective effect against&#xD;
        potential blue-light-induced damage to retinal cells.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomized, double-blind, parallel study conducted under medical supervision on a group of 54&#xD;
        volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational&#xD;
        products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler&#xD;
        test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be&#xD;
        assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life&#xD;
        Questionnaire. The studied parameters will be measured before and after supplementation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>DEQS (Dry Eye-Related Quality-of-Life) index</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>Subjective symptom questionnaire assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>Subjective symptom assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Optical Coherence Tomography</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amsler test</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>Amsler grid usually help detecting defects in central 20 degrees of the visual field</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Schirmer test,</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>Schirmer test quantitatively measures the tear production by the lacrimal gland</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Computerized Perimetry</measure>
      <time_frame>Baseline, 6 weeks</time_frame>
      <description>Computerized Perimetry is used to evaluate visual function</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Eye Abnormalities</condition>
    <arm_group>
      <arm_group_label>Complex product</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>18 volunteers</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Polyphenol-rich extracts</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>18 volunteers</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>18 volunteers</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Complex product</intervention_name>
      <description>Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules</description>
      <arm_group_label>Complex product</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Polyphenol-rich extracts</intervention_name>
      <description>Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules</description>
      <arm_group_label>Polyphenol-rich extracts</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Single oral dose - 2 capsules</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 25-45 years old.&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
            -  Volunteers who do not use glasses or contact lenses.&#xD;
  &#xD;
            -  Volunteers exposed to blue light for at least 6 - 8 hours a day.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins.&#xD;
  &#xD;
            -  Participation in another clinical trial.&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other&#xD;
               gastrointestinal diseases that may affect the results of the study.&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study, or&#xD;
               breastfeeding.&#xD;
  &#xD;
            -  Use of drugs that cause impaired vision or impaired tear secretion (including digoxin,&#xD;
               fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).&#xD;
  &#xD;
            -  Current use of eye drops in the treatment of ocular diseases.&#xD;
  &#xD;
            -  Ocular diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centrum Zdrowia Eter-Med sp. z o.o.</name>
        <address>
          <city>Gdańsk</city>
          <zip>80-822</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Barbara Khaidakov, PhD</last_name>
        <phone>798 210 651</phone>
        <phone_ext>+48</phone_ext>
        <email>barbara.khaidakov@aronpharma.pl</email>
      </contact>
      <investigator>
        <last_name>Janusz Wietecha</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Retinal cells</keyword>
    <keyword>Ocular diseases</keyword>
    <keyword>Blue-light</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eye Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004570
  org study id: 05-AP-RET
  nct id: NCT06004570
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to confirm that daily supplementation with a product containing a
        standardized combination of polyphenol-rich extracts has a protective effect against
        potential blue-light-induced damage to retinal cells.
  Randomized, double-blind, parallel study conducted under medical supervision on a group of 54
        volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational
        products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler
        test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be
        assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life
        Questionnaire. The studied parameters will be measured before and after supplementation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: DEQS (Dry Eye-Related Quality-of-Life) index
  time frame: Baseline, 6 weeks
  description: Subjective symptom questionnaire assessment
  measure: Visual Analogue Scale
  time frame: Baseline, 6 weeks
  description: Subjective symptom assessment
  measure: Optical Coherence Tomography
  time frame: Baseline, 6 weeks
  description: An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
  measure: Amsler test
  time frame: Baseline, 6 weeks
  description: Amsler grid usually help detecting defects in central 20 degrees of the visual field
  measure: Schirmer test,
  time frame: Baseline, 6 weeks
  description: Schirmer test quantitatively measures the tear production by the lacrimal gland
  measure: Computerized Perimetry
  time frame: Baseline, 6 weeks
  description: Computerized Perimetry is used to evaluate visual function
  arm group label: Complex product
  arm group type: Experimental
  description: 18 volunteers
  arm group label: Polyphenol-rich extracts
  arm group type: Active Comparator
  description: 18 volunteers
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 18 volunteers
  intervention type: Dietary Supplement
  intervention name: Complex product
  description: Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules
  arm group label: Complex product
  intervention type: Dietary Supplement
  intervention name: Polyphenol-rich extracts
  description: Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
  arm group label: Polyphenol-rich extracts
  intervention type: Other
  intervention name: Placebo
  description: Single oral dose - 2 capsules
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Eye Abnormalities
  sharing ipd: No