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/NCT06034379</url>
    </required_header>
    <id_info>
      <org_study_id>CP1:73200-TW</org_study_id>
      <nct_id>NCT06034379</nct_id>
    </id_info>
    <brief_title>Electronic Spectacles Versus Low Dose Atropine in Young Myopes</brief_title>
    <official_title>Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kubota Vision Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>China Medical University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Kubota Vision Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be&#xD;
        randomly assigned to one of the following: (1) Investigational CP1 device without atropine,&#xD;
        (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily&#xD;
        instillation of 0.01% atropine without use of the investigational CP1 device. Primary&#xD;
        endpoint: Difference in the changes of cycloplegic spherical refractive error and axial&#xD;
        length between each of the three treatment groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</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>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CSER</measure>
      <time_frame>12 months</time_frame>
      <description>Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AL</measure>
      <time_frame>12 months</time_frame>
      <description>Difference in the changes of axial length between each of the three treatment groups.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Myopia</condition>
    <arm_group>
      <arm_group_label>CP1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 hours per day of CP1 study device use</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CP1 and 0.01% atropine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 hours per day of CP1 study device use and nightly instillation of one drop of 0.01% atropine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.01% atropine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nightly instillation of one drop of 0.01% atropine</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CP1</intervention_name>
      <description>The CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina.</description>
      <arm_group_label>CP1</arm_group_label>
      <arm_group_label>CP1 and 0.01% atropine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.01% atropine</intervention_name>
      <description>Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.</description>
      <arm_group_label>0.01% atropine</arm_group_label>
      <arm_group_label>CP1 and 0.01% atropine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The subject must be between 6 and 13 years of age (inclusive).&#xD;
  &#xD;
            2. The subject must appear able and willing to adhere to the instructions set forth in&#xD;
               the clinical protocol.&#xD;
  &#xD;
            3. The guardian of a minor under 18 years old must read and sign the STATEMENT OF&#xD;
               INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old&#xD;
               must be willing to assent to the STATEMENT OF INFORMED CONSENT.&#xD;
  &#xD;
            4. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.&#xD;
  &#xD;
            5. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).&#xD;
  &#xD;
            6. Best corrected distance VA of at least 20/25 in each eye.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Currently pregnant or lactating&#xD;
  &#xD;
            2. History of severe dry eye, strabismus, or amblyopia&#xD;
  &#xD;
            3. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g.,&#xD;
               hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV),&#xD;
               autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by&#xD;
               self-report, which are known to interfere with the participation in the study at the&#xD;
               investigator's discretion.&#xD;
  &#xD;
            4. Use of systemic or ocular medications (e.g., chronic steroid use) that are known to&#xD;
               interfere with vision and ocular accommodation at the investigator's discretion.&#xD;
  &#xD;
            5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial&#xD;
               keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology&#xD;
  &#xD;
            6. Any active ocular infection.&#xD;
  &#xD;
            7. Any accommodative or binocular anomalies including amblyopia.&#xD;
  &#xD;
            8. Any physical or mental developmental delay.&#xD;
  &#xD;
            9. Any relevant ocular or systemic condition deemed unacceptable by the investigator that&#xD;
               may negatively impact the subject's performance or ability to successfully complete&#xD;
               the study (at the investigator's discretion)&#xD;
  &#xD;
           10. Anisometropia greater than 1.50D&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myopia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atropine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06034379
  org study id: CP1:73200-TW
  nct id: NCT06034379
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be
        randomly assigned to one of the following: (1) Investigational CP1 device without atropine,
        (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily
        instillation of 0.01% atropine without use of the investigational CP1 device. Primary
        endpoint: Difference in the changes of cycloplegic spherical refractive error and axial
        length between each of the three treatment groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: CSER
  time frame: 12 months
  description: Difference in the changes of cycloplegic spherical refractive error between each of the three treatment groups.
  measure: AL
  time frame: 12 months
  description: Difference in the changes of axial length between each of the three treatment groups.
  arm group label: CP1
  arm group type: Experimental
  description: 2 hours per day of CP1 study device use
  arm group label: CP1 and 0.01% atropine
  arm group type: Experimental
  description: 2 hours per day of CP1 study device use and nightly instillation of one drop of 0.01% atropine
  arm group label: 0.01% atropine
  arm group type: Experimental
  description: Nightly instillation of one drop of 0.01% atropine
  intervention type: Device
  intervention name: CP1
  description: The CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina.
  arm group label: CP1
  arm group label: CP1 and 0.01% atropine
  intervention type: Drug
  intervention name: 0.01% atropine
  description: Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
  arm group label: 0.01% atropine
  arm group label: CP1 and 0.01% atropine
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 13 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Myopia
  mesh term: Atropine