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/NCT06029530</url>
    </required_header>
    <id_info>
      <org_study_id>DONUT</org_study_id>
      <nct_id>NCT06029530</nct_id>
    </id_info>
    <brief_title>Delaying the Onset of Nearsightedness Until Treatment Study</brief_title>
    <acronym>DONUT</acronym>
    <official_title>Delaying the Onset of Nearsightedness Until Treatment Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Houston</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>State University of New York</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pennsylvania College of Optometry</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Southern California College of Optometry at Marshall B. Ketchum University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, Berkeley</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Case Western Reserve University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Illinois College of Optometry</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>New England College of Optometry</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of the Incarnate Word</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Southern College of Optometry</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Missouri, St. Louis</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ohio State University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        Participants eligible for the study will be randomized to one of three concentrations of&#xD;
        atropine and followed for a month.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be identified through screening that fit the criteria of a pre-myopic&#xD;
        child, which will depend on age and the amount of refractive error at that time. These&#xD;
        children will be randomized for a pilot study measuring compliance in nightly eye drop&#xD;
        administration. The outcome will be thirty days after randomization, and will assess whether&#xD;
        or not there is a difference in compliance between one of three dosages of atropine (0.01%,&#xD;
        0.03%, and 0.05%).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Compliance percentage</measure>
      <time_frame>30 days</time_frame>
      <description>A comparison of the compliance percentage with eye drop administration</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Myopia</condition>
    <arm_group>
      <arm_group_label>0.01% Atropine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.01% atropine eye drops</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.03% Atropine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.03% atropine eye drops</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.05% atropine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.05% atropine eye drops</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atropine Ophthalmic</intervention_name>
      <description>eye drops to be administered once daily</description>
      <arm_group_label>0.01% Atropine</arm_group_label>
      <arm_group_label>0.03% Atropine</arm_group_label>
      <arm_group_label>0.05% atropine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 6-11 years&#xD;
  &#xD;
            -  Refractive error measured in spherical equivalent, one eye meets criterion&#xD;
  &#xD;
                 -  6 years old: 0.50 to +0.38&#xD;
  &#xD;
                 -  7 years old: 0.50 to +0.25&#xD;
  &#xD;
                 -  8-11 years old: 0.50 to plano&#xD;
  &#xD;
            -  Anisometropia: spherical equivalent &lt;1.50 D&#xD;
  &#xD;
            -  Astigmatism: &lt;1.50 in both eyes&#xD;
  &#xD;
            -  Myopia: Less myopic than -0.74 D, both eyes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          ● Myopic&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeffrey J Walline, OD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Ohio State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeffrey J Walline, OD PhD</last_name>
      <phone>6142476840</phone>
      <email>walline.1@osu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lisa A Jordan, PhD</last_name>
      <phone>6142477321</phone>
      <email>jordan.646@osu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Jeffrey J. Walline, OD PhD</investigator_full_name>
      <investigator_title>Associate Dean for Research, College of Optometry</investigator_title>
    </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>
    <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/NCT06029530
  org study id: DONUT
  nct id: NCT06029530
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
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  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Participants eligible for the study will be randomized to one of three concentrations of
        atropine and followed for a month.
  Participants will be identified through screening that fit the criteria of a pre-myopic
        child, which will depend on age and the amount of refractive error at that time. These
        children will be randomized for a pilot study measuring compliance in nightly eye drop
        administration. The outcome will be thirty days after randomization, and will assess whether
        or not there is a difference in compliance between one of three dosages of atropine (0.01%,
        0.03%, and 0.05%).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.
  measure: Compliance percentage
  time frame: 30 days
  description: A comparison of the compliance percentage with eye drop administration
  arm group label: 0.01% Atropine
  arm group type: Active Comparator
  description: 0.01% atropine eye drops
  arm group label: 0.03% Atropine
  arm group type: Active Comparator
  description: 0.03% atropine eye drops
  arm group label: 0.05% atropine
  arm group type: Active Comparator
  description: 0.05% atropine eye drops
  intervention type: Drug
  intervention name: Atropine Ophthalmic
  description: eye drops to be administered once daily
  arm group label: 0.01% Atropine
  arm group label: 0.03% Atropine
  arm group label: 0.05% atropine
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 11 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeffrey J Walline, OD PhD
  role: Study Chair
  affiliation: Ohio State University
  last name: Jeffrey J Walline, OD PhD
  phone: 6142476840
  email: walline.1@osu.edu
  last name: Lisa A Jordan, PhD
  phone: 6142477321
  email: jordan.646@osu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University
  investigator full name: Jeffrey J. Walline, OD PhD
  investigator title: Associate Dean for Research, College of Optometry
  mesh term: Myopia
  mesh term: Atropine
  sharing ipd: No