<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/NCT03761758</url>
  </required_header>
  <id_info>
    <org_study_id>P/639/18/SG</org_study_id>
    <nct_id>NCT03761758</nct_id>
  </id_info>
  <brief_title>Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast</brief_title>
  <acronym>WALNUT</acronym>
  <official_title>Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric&#xD;
      acceptability across three iterations of a novel spectacle lens design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This feasibility study was conducted to assess the performance of three experimental&#xD;
      spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with&#xD;
      myopia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">July 19, 2018</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>Device Feasibility</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance Visual Acuity</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measurement of best corrected distance visual acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contrast Sensitivity</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measurement of contrast sensitivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Responses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Assessment of subject responses related to wear time of spectacles</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Lens Design 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spectacle lenses design 1, fitted into spectacle frames</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lens Design 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spectacle lenses design 2, fitted into spectacle frames</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lens Design 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spectacle lenses design 3, fitted into spectacle frames</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectacle lenses</intervention_name>
    <description>Spectacle lenses with clear central apertures</description>
    <arm_group_label>Lens Design 1</arm_group_label>
    <arm_group_label>Lens Design 2</arm_group_label>
    <arm_group_label>Lens Design 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 6 and 12 years&#xD;
&#xD;
          -  Myopia between -1.00 and -4.00 D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in any clinical or other research study&#xD;
&#xD;
          -  Contact lens wearer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joe Rappon, OD, MS</last_name>
    <role>Study Director</role>
    <affiliation>SightGlass Vision</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Ocular Research &amp; Education</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03761758
org study id: P/639/18/SG
nct id: NCT03761758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric
      acceptability across three iterations of a novel spectacle lens design.
This feasibility study was conducted to assess the performance of three experimental
      spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with
      myopia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Single (Participant)
measure: Distance Visual Acuity
time frame: 2 weeks
description: Measurement of best corrected distance visual acuity
measure: Contrast Sensitivity
time frame: 2 weeks
description: Measurement of contrast sensitivity
measure: Subjective Responses
time frame: 2 weeks
description: Assessment of subject responses related to wear time of spectacles
arm group label: Lens Design 1
arm group type: Experimental
description: Spectacle lenses design 1, fitted into spectacle frames
arm group label: Lens Design 2
arm group type: Experimental
description: Spectacle lenses design 2, fitted into spectacle frames
arm group label: Lens Design 3
arm group type: Experimental
description: Spectacle lenses design 3, fitted into spectacle frames
intervention type: Device
intervention name: Spectacle lenses
description: Spectacle lenses with clear central apertures
arm group label: Lens Design 1
arm group label: Lens Design 2
arm group label: Lens Design 3
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joe Rappon, OD, MS
role: Study Director
affiliation: SightGlass Vision
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No