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/NCT06034327</url>
    </required_header>
    <id_info>
      <org_study_id>CPRO-2304-001</org_study_id>
      <nct_id>NCT06034327</nct_id>
    </id_info>
    <brief_title>Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens</brief_title>
    <acronym>EUCALYPTUS</acronym>
    <official_title>Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SightGlass Vision, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>SightGlass Vision, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a conventional efficacy trial to validate the results from previous clinical trials&#xD;
        for younger children; the 12-month efficacy results will be used to predict the 3-year&#xD;
        treatment efficacy.&#xD;
  &#xD;
        This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm&#xD;
        parallel group study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 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 (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Spherical equivalent refraction</measure>
      <time_frame>12 months</time_frame>
      <description>Change in spherical equivalent refraction from baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Axial length</measure>
      <time_frame>12 months</time_frame>
      <description>Change in axial length from baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Myopia</condition>
    <condition>Juvenile Myopia</condition>
    <condition>Myopia Progression</condition>
    <arm_group>
      <arm_group_label>Test Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single vision, impact-resistant spectacle lenses</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test Arm 2</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Single vision, impact-resistant spectacle lenses</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Single vision, impact-resistant spectacle lenses; Test Arm</intervention_name>
      <description>Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia</description>
      <arm_group_label>Test Arm 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Single vision, impact-resistant spectacle lenses; Control Arm</intervention_name>
      <description>Single vision, impact-resistant spectacle lenses</description>
      <arm_group_label>Test Arm 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;&#xD;
  &#xD;
            2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest&#xD;
               refraction) in each eye;&#xD;
  &#xD;
            3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in&#xD;
               each eye;&#xD;
  &#xD;
            4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen&#xD;
               equivalent) or better in each eye;&#xD;
  &#xD;
            5. The difference in spherical equivalent power between the two eyes (anisometropia based&#xD;
               on manifest refraction) must be less than or equal to 1.50 D;&#xD;
  &#xD;
            6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or&#xD;
               other activities in which spectacle wear would be dangerous or otherwise not possible&#xD;
               (minimum of 10 hours per day);&#xD;
  &#xD;
            7. Ability to comply with study procedures, including high and low contrast visual&#xD;
               acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes&#xD;
               at the baseline visit;&#xD;
  &#xD;
            8. Willingness to participate in the trial for 24 months without contact lens wear;&#xD;
  &#xD;
            9. The subject's parent(s) or legal guardian(s) must read, understand and sign the&#xD;
               Statement of Informed Consent and receive a fully executed copy of the form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has previously or currently wears contact lenses (greater than 1-month usage);&#xD;
  &#xD;
            2. Current or prior use of bifocals, progressive addition spectacle lenses&#xD;
  &#xD;
            3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal&#xD;
               contact lenses, orthokeratology);&#xD;
  &#xD;
            4. Amblyopia in either eye;&#xD;
  &#xD;
            5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;&#xD;
  &#xD;
            6. Any ocular or systemic conditions that could influence refractive development or&#xD;
               status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan&#xD;
               syndrome or other connective tissue disorder, Down's syndrome, family history of poor&#xD;
               night vision (to prevent against enrolling subjects with congenital stationary night&#xD;
               blindness)];&#xD;
  &#xD;
            7. Known allergy to proparacaine, tetracaine, or tropicamide;&#xD;
  &#xD;
            8. Participation in any investigational clinical study within 30 days of the Baseline&#xD;
               visit;&#xD;
  &#xD;
            9. Subject's sibling or other household member is already enrolled in this trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jennifer S Hill, BS</last_name>
      <phone>678-361-4877</phone>
      <email>jhill@sightglassvision.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vanessa Tasso, MA, MBA</last_name>
      <phone>949-751-7039</phone>
      <email>vtasso@sightglassvision.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Advanced Eyecare PC</name>
        <address>
          <city>Raytown</city>
          <state>Missouri</state>
          <zip>64133</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tamara Urias</last_name>
        <phone>816-353-1872</phone>
        <email>turias@eyecarespecialtiesmo.com</email>
      </contact>
      <investigator>
        <last_name>Richard Wilson, OD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Athens Eye Care</name>
        <address>
          <city>Athens</city>
          <state>Ohio</state>
          <zip>45701</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jen Brite</last_name>
        <email>jen@athenseyecare.com</email>
      </contact>
      <contact_backup>
        <last_name>Shane Foster, OD</last_name>
      </contact_backup>
      <investigator>
        <last_name>Shane Foster, OD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Procare Vision Centers, Inc.</name>
        <address>
          <city>Granville</city>
          <state>Ohio</state>
          <zip>43023</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Katherine Bickle, OD</last_name>
      </contact>
      <investigator>
        <last_name>Katherine Bickle, OD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Bellaire Family Eye Care</name>
        <address>
          <city>Bellaire</city>
          <state>Texas</state>
          <zip>77401</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashley Tucker, OD</last_name>
      </contact>
      <investigator>
        <last_name>Ashley Tucker, OD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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>
    <!-- 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/NCT06034327
  org study id: CPRO-2304-001
  nct id: NCT06034327
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This is a conventional efficacy trial to validate the results from previous clinical trials
        for younger children; the 12-month efficacy results will be used to predict the 3-year
        treatment efficacy.
  
        This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm
        parallel group study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
  measure: Spherical equivalent refraction
  time frame: 12 months
  description: Change in spherical equivalent refraction from baseline
  measure: Axial length
  time frame: 12 months
  description: Change in axial length from baseline
  arm group label: Test Arm 1
  arm group type: Experimental
  description: Single vision, impact-resistant spectacle lenses
  arm group label: Test Arm 2
  arm group type: Other
  description: Single vision, impact-resistant spectacle lenses
  intervention type: Device
  intervention name: Single vision, impact-resistant spectacle lenses; Test Arm
  description: Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
  arm group label: Test Arm 1
  intervention type: Device
  intervention name: Single vision, impact-resistant spectacle lenses; Control Arm
  description: Single vision, impact-resistant spectacle lenses
  arm group label: Test Arm 2
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 8 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jennifer S Hill, BS
  phone: 678-361-4877
  email: jhill@sightglassvision.com
  last name: Vanessa Tasso, MA, MBA
  phone: 949-751-7039
  email: vtasso@sightglassvision.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Myopia