<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/NCT01729208</url>
  </required_header>
  <id_info>
    <org_study_id>CVI08008</org_study_id>
    <nct_id>NCT01729208</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression</brief_title>
  <official_title>A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Visioncare Research Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coopervision, 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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a new type of soft contact lens with a&#xD;
      unique optical design (dual focus) is effective at slowing the progression of myopia&#xD;
      (near-sightedness) in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomized to wear test or control soft contact lens to determine whether a new&#xD;
      type of soft contact lens with a unique optical design (dual focus) is effective at slowing&#xD;
      the progression of myopia (near-sightedness) in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2017</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Refractive Error Relative to Baseline</measure>
    <time_frame>12 months</time_frame>
    <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Refractive Error Relative to Baseline</measure>
    <time_frame>24 months</time_frame>
    <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Refractive Error Relative to Baseline</measure>
    <time_frame>36 months</time_frame>
    <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Axial Length Relative to Baseline</measure>
    <time_frame>12 months</time_frame>
    <description>Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Axial Length Relative to Baseline</measure>
    <time_frame>24 months</time_frame>
    <description>Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Axial Length Relative to Baseline</measure>
    <time_frame>36 months</time_frame>
    <description>Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</measure>
    <time_frame>Baseline</time_frame>
    <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</measure>
    <time_frame>12 months</time_frame>
    <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Biomicroscopic Findings</measure>
    <time_frame>24 months</time_frame>
    <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Biomicroscopic Findings Greater Than Grade 2.</measure>
    <time_frame>36 months</time_frame>
    <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Cumulative incidence of adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>24 months</time_frame>
    <description>Cumulative incidence of adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>36 months</time_frame>
    <description>Cumulative incidence of adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Dual Focus Soft Contact Lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual Focus Soft Contact Lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Vision Soft Contact Lens</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single Vision Soft Contact Lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual Focus Soft Contact Lens</intervention_name>
    <arm_group_label>Dual Focus Soft Contact Lens</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Single Vision Soft Contact Lens</intervention_name>
    <arm_group_label>Single Vision Soft Contact Lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 8 and 12 years of age inclusive.&#xD;
&#xD;
          -  Best-corrected visual acuity by manifest refraction of +0.10 logMAR.&#xD;
&#xD;
          -  Spherical Equivalent Refractive Error between -0.75 and -4.00 D&#xD;
&#xD;
          -  inclusive astigmatism: &lt; -0.75 D and anisometropia: &lt; 1.00 D&#xD;
&#xD;
          -  Possess wearable and visually functional eyeglasses.&#xD;
&#xD;
          -  Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at&#xD;
             least 6 days per week, for the duration of the 3 year study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has previously or currently wears contact lenses or rigid gas permeable&#xD;
             contact lenses, including orthokeratology lenses.&#xD;
&#xD;
          -  Subject is currently or within 30 days prior to this study has been an active&#xD;
             participant in another clinical study.&#xD;
&#xD;
          -  Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine&#xD;
             or ANY other myopia control treatment.&#xD;
&#xD;
          -  Regular use of ocular medications (prescription or over-the-counter), artificial&#xD;
             tears, or wetting agents.&#xD;
&#xD;
          -  Current use of systemic medications which may significantly affect contact lens wear,&#xD;
             tear film production, pupil size, accommodation or refractive state.&#xD;
&#xD;
          -  A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.&#xD;
&#xD;
          -  Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.&#xD;
&#xD;
          -  Any ocular, systemic or neuro-developmental conditions that could influence refractive&#xD;
             development.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José Manuel González-Méijome</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Waterloo School of Optometry</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minho Clinical &amp; Experiment Optometry Research Lab</name>
      <address>
        <city>Braga</city>
        <zip>4710-057</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University of Singapore Faculty of Medicine</name>
      <address>
        <city>Singapore</city>
        <zip>117597</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aston University Ophthalmic Research Group</name>
      <address>
        <city>Birmingham</city>
        <zip>B4 7ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Portugal</country>
    <country>Singapore</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>December 19, 2019</results_first_submitted>
  <results_first_submitted_qc>February 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 24, 2020</results_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myopia progression</keyword>
  <keyword>myopia control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 26, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT01729208/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT01729208/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dual Focus Soft Contact Lens</title>
          <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
        </group>
        <group group_id="P2">
          <title>Single Vision Soft Contact Lens</title>
          <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12 Months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>24 Months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>36 Months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects were randomized to wear dual focus soft contact lens and single vision soft contact lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Dual Focus Soft Contact Lens</title>
          <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
        </group>
        <group group_id="B2">
          <title>Single Vision Soft Contact Lens</title>
          <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="144"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.1" spread="1.3"/>
                    <measurement group_id="B2" value="10.1" spread="1.4"/>
                    <measurement group_id="B3" value="10.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>East Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indian/Pakistani/Sri Lankan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Refractive Error Relative to Baseline</title>
        <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Refractive Error Relative to Baseline</title>
          <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.</description>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.39"/>
                    <measurement group_id="O2" value="-0.58" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Refractive Error Relative to Baseline</title>
        <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Refractive Error Relative to Baseline</title>
          <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.</description>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.52"/>
                    <measurement group_id="O2" value="-0.92" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Refractive Error Relative to Baseline</title>
        <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.</description>
        <time_frame>36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Refractive Error Relative to Baseline</title>
          <description>Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.</description>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="0.64"/>
                    <measurement group_id="O2" value="-1.24" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Axial Length Relative to Baseline</title>
        <description>Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Axial Length Relative to Baseline</title>
          <description>Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.13"/>
                    <measurement group_id="O2" value="0.24" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Axial Length Relative to Baseline</title>
        <description>Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Axial Length Relative to Baseline</title>
          <description>Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.22"/>
                    <measurement group_id="O2" value="0.45" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Axial Length Relative to Baseline</title>
        <description>Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.</description>
        <time_frame>36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Axial Length Relative to Baseline</title>
          <description>Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="0.28"/>
                    <measurement group_id="O2" value="0.62" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</title>
        <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</title>
          <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corneal Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjuctival Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Roughness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascularization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;Other&quot; Findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</title>
        <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2</title>
          <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corneal Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjuctival Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Roughness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascularization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;Other&quot; Findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Biomicroscopic Findings</title>
        <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biomicroscopic Findings</title>
          <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corneal Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjuctival Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Roughness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascularization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;Other&quot; Findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2.</title>
        <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
        <time_frame>36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biomicroscopic Findings Greater Than Grade 2.</title>
          <description>Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corneal Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjuctival Staining</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Hyperemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Roughness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascularization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;Other&quot; Findings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Adverse Events</title>
        <description>Cumulative incidence of adverse events.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events</title>
          <description>Cumulative incidence of adverse events.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-significant infiltrative event- device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blepharitis - not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Localized allergic reaction - device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Localized allergic reaction-not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant-Other-Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant-Other- Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Foreign Body -Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal event -Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal event- Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meibomianitis - Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Adverse Events</title>
        <description>Cumulative incidence of adverse events.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events</title>
          <description>Cumulative incidence of adverse events.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Conjuctivitis - Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant Other - Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant Other - Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant infiltrative event Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Adverse Events</title>
        <description>Cumulative incidence of adverse events.</description>
        <time_frame>36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dual Focus Soft Contact Lens</title>
            <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Single Vision Soft Contact Lens</title>
            <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events</title>
          <description>Cumulative incidence of adverse events.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Conjuctivitis - Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant Other - Device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant Other - Not device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-significant infiltrative event-no device relat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal event- device related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense of soft contact lenses till 36 months follow-up visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dual Focus Soft Contact Lens</title>
          <description>Dual Focus Soft Contact Lens&#xD;
Dual Focus Soft Contact Lens</description>
        </group>
        <group group_id="E2">
          <title>Single Vision Soft Contact Lens</title>
          <description>Single Vision Soft Contact Lens&#xD;
Single Vision Soft Contact Lens</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul Chamberlain</name_or_title>
      <organization>CooperVision Inc.</organization>
      <phone>925 730-6754</phone>
      <email>PChamberlain@coopervision.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01729208
org study id: CVI08008
nct id: NCT01729208
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine whether a new type of soft contact lens with a
      unique optical design (dual focus) is effective at slowing the progression of myopia
      (near-sightedness) in children.
Subjects were randomized to wear test or control soft contact lens to determine whether a new
      type of soft contact lens with a unique optical design (dual focus) is effective at slowing
      the progression of myopia (near-sightedness) in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Refractive Error Relative to Baseline
time frame: 12 months
description: Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
measure: Change in Refractive Error Relative to Baseline
time frame: 24 months
description: Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
measure: Change in Refractive Error Relative to Baseline
time frame: 36 months
description: Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
measure: Change in Axial Length Relative to Baseline
time frame: 12 months
description: Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
measure: Change in Axial Length Relative to Baseline
time frame: 24 months
description: Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
measure: Change in Axial Length Relative to Baseline
time frame: 36 months
description: Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2
time frame: Baseline
description: Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2
time frame: 12 months
description: Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
measure: Number of Participants With Biomicroscopic Findings
time frame: 24 months
description: Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
measure: Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
time frame: 36 months
description: Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
measure: Incidence of Adverse Events
time frame: 12 months
description: Cumulative incidence of adverse events.
measure: Incidence of Adverse Events
time frame: 24 months
description: Cumulative incidence of adverse events.
measure: Incidence of Adverse Events
time frame: 36 months
description: Cumulative incidence of adverse events.
arm group label: Dual Focus Soft Contact Lens
arm group type: Experimental
description: Dual Focus Soft Contact Lens
arm group label: Single Vision Soft Contact Lens
arm group type: Placebo Comparator
description: Single Vision Soft Contact Lens
intervention type: Device
intervention name: Dual Focus Soft Contact Lens
arm group label: Dual Focus Soft Contact Lens
intervention type: Device
intervention name: Single Vision Soft Contact Lens
arm group label: Single Vision Soft Contact Lens
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
last name: José Manuel González-Méijome
role: Principal Investigator
affiliation: University of Minho
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Portugal
country: Singapore
country: United Kingdom
responsible party type: Sponsor
mesh term: Myopia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 