<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/NCT02255474</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0231</org_study_id>
    <secondary_id>U10EY023208</secondary_id>
    <nct_id>NCT02255474</nct_id>
  </id_info>
  <brief_title>Bifocal Lenses In Nearsighted Kids</brief_title>
  <acronym>BLINK</acronym>
  <official_title>Soft Bifocal Contact Lens Myopia Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the use of two different bifocal contact lens add powers to prevent&#xD;
      further nearsighted progression in children ages 7 to 11 years old. It is theorized that the&#xD;
      profile of the bifocal lenses will decrease the amount of change in nearsightedness that the&#xD;
      children experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of this project is to determine whether a commercially available soft&#xD;
      bifocal contact lens with a distance-center design can slow myopia progression in children.&#xD;
      Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel&#xD;
      use for a standard contact lens that may keep children from becoming as nearsighted as they&#xD;
      would otherwise. Secondary goals are to determine whether the amount of myopic defocus&#xD;
      imposed on the peripheral retina by soft bifocal contact lenses is associated in a&#xD;
      dose-dependent manner with slowed myopic progression and to determine whether peripheral&#xD;
      myopic blur acts to slow eye growth locally or globally. These important pieces of&#xD;
      information will enable investigators to learn about the role of peripheral optics for&#xD;
      regulating eye growth, which could ultimately lead to optimization of optical signals to slow&#xD;
      myopia progression. Ultimately, the information could be used to design optical devices to&#xD;
      prevent the onset of myopia in young children.&#xD;
&#xD;
      Slowing myopia progression or eventually preventing myopia onset could potentially affect&#xD;
      approximately 60 million children in the United States alone. While the consequences of&#xD;
      myopia are rarely sight-threatening, the quality of life for myopic patients is negatively&#xD;
      affected and the health care costs to treat myopia are astronomical (approximately $4.6&#xD;
      billion in 1990). The National Eye Institute recognizes the need to &quot;evaluate the efficacy of&#xD;
      potential treatments for delaying the onset or for slowing the progression of myopia, such as&#xD;
      lenses that alter peripheral defocus.&quot;&#xD;
&#xD;
      Using a common treatment of myopia (contact lenses) to potentially slow myopia progression&#xD;
      and to learn about optical signals that regulate eye growth is a very novel approach to&#xD;
      solving a problem that affects a large proportion of people in the United States.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2014</start_date>
  <completion_date type="Actual">June 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Refractive Error Progression</measure>
    <time_frame>3 years</time_frame>
    <description>Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Shape Change and Eye Growth</measure>
    <time_frame>3 years</time_frame>
    <description>The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of Peripheral Defocus to Myopic Progression</measure>
    <time_frame>3 years</time_frame>
    <description>Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Axial Length Progression</measure>
    <time_frame>3 years</time_frame>
    <description>Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">294</enrollment>
  <condition>Refractive Errors</condition>
  <arm_group>
    <arm_group_label>Biofinity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Soft spherical contact lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofinity Multifocal D +1.50 add</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Biofinity Multifocal &quot;D&quot; with a +1.50 add is a soft bifocal contact lens that has a medium reading power</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofinity Multifocal D +2.50 add</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Biofinity Multifocal &quot;D&quot; with a +2.50 add is a soft bifocal contact lens that has a strong reading power</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofinity Multifocal D +1.50 add</intervention_name>
    <description>This is a monthly disposable contact lens commercially available from CooperVision</description>
    <arm_group_label>Biofinity Multifocal D +1.50 add</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofinity Multifocal D +2.50 add</intervention_name>
    <description>This is a monthly disposable contact lens commercially available from CooperVision</description>
    <arm_group_label>Biofinity Multifocal D +2.50 add</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofinity</intervention_name>
    <description>This is a monthly disposable spherical contact lens commercially available from CooperVision</description>
    <arm_group_label>Biofinity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  7 to 11 years, inclusive, at baseline examination&#xD;
&#xD;
          -  -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction&#xD;
&#xD;
          -  ≤1.00 DC, cycloplegic autorefraction&#xD;
&#xD;
          -  ≥ 2.00 D difference between the sphere components of the two eyes (anisometropia),&#xD;
             cycloplegic autorefraction&#xD;
&#xD;
          -  0.1 logMAR or better best-corrected visual acuity in each eye&#xD;
&#xD;
          -  0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact&#xD;
             lens&#xD;
&#xD;
          -  +2.50 D add lens provides adequate fit with respect to movement and centration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor&#xD;
             nerve palsies, corneal disease, etc.)&#xD;
&#xD;
          -  Systemic disease that may affect vision, vision development, or contact lens wear (eg,&#xD;
             diabetes, Down syndrome, etc.)&#xD;
&#xD;
          -  Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or&#xD;
             bifocal/PAL spectacle wear (longer than 1 month of wear)&#xD;
&#xD;
          -  Previous or current participation in myopia control studies&#xD;
&#xD;
          -  Chronic use of medications that may affect immunity, such as oral or ophthalmic&#xD;
             corticosteroids for ocular or systemic diseases&#xD;
&#xD;
          -  Issues that may interfere with the ability to participate over the next 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Walline, OD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University College of Optometry</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Houston College of Optometry</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>June 24, 2020</results_first_submitted>
  <results_first_submitted_qc>February 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2021</results_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jeffrey J. Walline, OD PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pediatrics</keyword>
  <keyword>refractive error - myopia</keyword>
  <keyword>contact lenses</keyword>
  <keyword>intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form: University of Houston Informed Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02255474/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02255474/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Ohio State University Clinical Site</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 5, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02255474/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Biofinity</title>
          <description>Soft spherical contact lens&#xD;
Biofinity: This is a monthly disposable spherical contact lens commercially available from CooperVision</description>
        </group>
        <group group_id="P2">
          <title>Biofinity Multifocal D +1.50 Add</title>
          <description>The Biofinity Multifocal &quot;D&quot; with a +1.50 add is a soft bifocal contact lens that has a medium reading power&#xD;
Biofinity Multifocal D +1.50 add: This is a monthly disposable contact lens commercially available from CooperVision</description>
        </group>
        <group group_id="P3">
          <title>Biofinity Multifocal D +2.50 Add</title>
          <description>The Biofinity Multifocal &quot;D&quot; with a +2.50 add is a soft bifocal contact lens that has a strong reading power&#xD;
Biofinity Multifocal D +2.50 add: This is a monthly disposable contact lens commercially available from CooperVision</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="98"/>
                <participants group_id="P3" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="96"/>
                <participants group_id="P3" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </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="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Biofinity</title>
          <description>Single vision soft contact lens</description>
        </group>
        <group group_id="B2">
          <title>Biofinity +1.50 D Add</title>
          <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
        </group>
        <group group_id="B3">
          <title>Biofinity +2.50 D Add</title>
          <description>High add soft bifocal contact lens (+2.50 Diopter add)</description>
        </group>
        <group group_id="B4">
          <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="98"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="98"/>
            <count group_id="B4" value="294"/>
          </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="98"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="294"/>
                  </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 group_id="B4" 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 group_id="B4" 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="10.3" spread="1.1"/>
                    <measurement group_id="B2" value="10.3" spread="1.2"/>
                    <measurement group_id="B3" value="10.36" spread="1.2"/>
                    <measurement group_id="B4" value="10.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <title>7 to 9 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10 to 11 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="177"/>
                  </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="64"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Site</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Columbus, OH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Houston, TX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spherical equivalent</title>
          <description>Diopters</description>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-2.46" spread="0.97"/>
                    <measurement group_id="B2" value="-2.43" spread="1.11"/>
                    <measurement group_id="B3" value="-2.28" spread="0.90"/>
                    <measurement group_id="B4" value="-2.39" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Axial length</title>
          <description>mm</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.45" spread="0.83"/>
                    <measurement group_id="B2" value="24.57" spread="0.85"/>
                    <measurement group_id="B3" value="24.43" spread="0.74"/>
                    <measurement group_id="B4" value="24.48" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral axial length</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>20 degree inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.27" spread="0.83"/>
                    <measurement group_id="B2" value="24.37" spread="0.85"/>
                    <measurement group_id="B3" value="24.24" spread="0.74"/>
                    <measurement group_id="B4" value="24.29" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.16" spread="0.85"/>
                    <measurement group_id="B2" value="24.31" spread="0.95"/>
                    <measurement group_id="B3" value="24.15" spread="0.86"/>
                    <measurement group_id="B4" value="24.20" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.38" spread="0.84"/>
                    <measurement group_id="B2" value="24.45" spread="0.85"/>
                    <measurement group_id="B3" value="24.36" spread="0.79"/>
                    <measurement group_id="B4" value="24.40" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.07" spread="0.85"/>
                    <measurement group_id="B2" value="24.20" spread="0.84"/>
                    <measurement group_id="B3" value="24.06" spread="0.74"/>
                    <measurement group_id="B4" value="24.11" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.03" spread="0.81"/>
                    <measurement group_id="B2" value="24.13" spread="0.82"/>
                    <measurement group_id="B3" value="24.01" spread="0.72"/>
                    <measurement group_id="B4" value="24.06" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.08" spread="0.85"/>
                    <measurement group_id="B2" value="24.22" spread="0.87"/>
                    <measurement group_id="B3" value="24.07" spread="0.79"/>
                    <measurement group_id="B4" value="24.13" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.20" spread="0.86"/>
                    <measurement group_id="B2" value="24.25" spread="0.86"/>
                    <measurement group_id="B3" value="24.19" spread="0.80"/>
                    <measurement group_id="B4" value="24.21" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.69" spread="0.820"/>
                    <measurement group_id="B2" value="23.82" spread="0.80"/>
                    <measurement group_id="B3" value="23.69" spread="0.73"/>
                    <measurement group_id="B4" value="23.73" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral defocus</title>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>40 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.17" spread="1.17"/>
                    <measurement group_id="B2" value="1.07" spread="1.30"/>
                    <measurement group_id="B3" value="0.44" spread="1.23"/>
                    <measurement group_id="B4" value="1.23" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.06" spread="0.84"/>
                    <measurement group_id="B2" value="0.16" spread="1.02"/>
                    <measurement group_id="B3" value="-0.37" spread="0.95"/>
                    <measurement group_id="B4" value="0.28" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.54" spread="0.81"/>
                    <measurement group_id="B2" value="-0.10" spread="0.77"/>
                    <measurement group_id="B3" value="-0.37" spread="0.75"/>
                    <measurement group_id="B4" value="0.02" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.56" spread="0.75"/>
                    <measurement group_id="B2" value="-0.27" spread="0.79"/>
                    <measurement group_id="B3" value="-0.86" spread="0.74"/>
                    <measurement group_id="B4" value="-0.19" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.29" spread="1.06"/>
                    <measurement group_id="B2" value="0.27" spread="1.07"/>
                    <measurement group_id="B3" value="-0.35" spread="1.21"/>
                    <measurement group_id="B4" value="0.40" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.92" spread="1.64"/>
                    <measurement group_id="B2" value="1.33" spread="1.71"/>
                    <measurement group_id="B3" value="0.87" spread="1.64"/>
                    <measurement group_id="B4" value="1.37" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Refractive Error Progression</title>
        <description>Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofinity</title>
            <description>Spherical soft contact lens</description>
          </group>
          <group group_id="O2">
            <title>Biofinity +1.50 D Add</title>
            <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
          </group>
          <group group_id="O3">
            <title>Biofinity +2.50 D Add</title>
            <description>High add soft bifocal contact lens (+2.50 Diopter add)</description>
          </group>
        </group_list>
        <measure>
          <title>Refractive Error Progression</title>
          <description>Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.46" spread="1.20"/>
                    <measurement group_id="O2" value="-3.32" spread="1.48"/>
                    <measurement group_id="O3" value="-2.84" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Both eyes used in analysis adjusting for correlation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Adjusted for multiple comparisons, treatment group p-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.01</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Shape Change and Eye Growth</title>
        <description>The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).</description>
        <time_frame>3 years</time_frame>
        <population>Analysis of peripheral eye length changes with treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Biofinity</title>
            <description>Single vision soft contact lens</description>
          </group>
          <group group_id="O2">
            <title>Biofinity +1.50 D Add</title>
            <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
          </group>
          <group group_id="O3">
            <title>Biofinity +2.50 D Add</title>
            <description>High add soft bifocal contact lens (+2.50 Diopter add)</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Shape Change and Eye Growth</title>
          <description>The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).</description>
          <population>Analysis of peripheral eye length changes with treatment</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>20 degree inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.92" spread="0.85"/>
                    <measurement group_id="O2" value="24.94" spread="0.97"/>
                    <measurement group_id="O3" value="24.64" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.86" spread="0.87"/>
                    <measurement group_id="O2" value="24.90" spread="1.09"/>
                    <measurement group_id="O3" value="24.60" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.98" spread="0.89"/>
                    <measurement group_id="O2" value="24.98" spread="0.97"/>
                    <measurement group_id="O3" value="24.74" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.98" spread="0.89"/>
                    <measurement group_id="O2" value="24.98" spread="0.97"/>
                    <measurement group_id="O3" value="24.71" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.64" spread="0.83"/>
                    <measurement group_id="O2" value="24.68" spread="0.94"/>
                    <measurement group_id="O3" value="24.45" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.70" spread="0.84"/>
                    <measurement group_id="O2" value="24.79" spread="1.01"/>
                    <measurement group_id="O3" value="24.51" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.76" spread="0.92"/>
                    <measurement group_id="O2" value="247.77" spread="0.95"/>
                    <measurement group_id="O3" value="24.58" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 degree temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.30" spread="0.82"/>
                    <measurement group_id="O2" value="24.29" spread="0.91"/>
                    <measurement group_id="O3" value="24.04" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>quadratic coefficient</param_type>
            <param_value>0.02</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association of Peripheral Defocus to Myopic Progression</title>
        <description>Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).</description>
        <time_frame>3 years</time_frame>
        <population>outcome is three-year change in refractive error as a function of baseline peripheral defocus</population>
        <group_list>
          <group group_id="O1">
            <title>Biofinity</title>
            <description>Single vision soft contact lens</description>
          </group>
          <group group_id="O2">
            <title>Biofinity +1.50 D Add</title>
            <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
          </group>
          <group group_id="O3">
            <title>Biofinity +2.50 D Add</title>
            <description>High add soft bifocal contact lens (+2.50 Diopter add)</description>
          </group>
        </group_list>
        <measure>
          <title>Association of Peripheral Defocus to Myopic Progression</title>
          <description>Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).</description>
          <population>outcome is three-year change in refractive error as a function of baseline peripheral defocus</population>
          <units>Diopters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.01" spread="0.66"/>
                    <measurement group_id="O2" value="-0.85" spread="0.82"/>
                    <measurement group_id="O3" value="-0.56" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Regression, Linear</method>
            <method_desc>Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.</method_desc>
            <param_type>regression coefficient</param_type>
            <param_value>-0.12</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Axial Length Progression</title>
        <description>Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofinity</title>
            <description>Spherical soft contact lens</description>
          </group>
          <group group_id="O2">
            <title>Biofinity +1.50 D Add</title>
            <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
          </group>
          <group group_id="O3">
            <title>Biofinity +2.50 D Add</title>
            <description>High add soft bifocal contact lens (+2.50 Diopter add)</description>
          </group>
        </group_list>
        <measure>
          <title>Axial Length Progression</title>
          <description>Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.08" spread="0.85"/>
                    <measurement group_id="O2" value="25.12" spread="0.97"/>
                    <measurement group_id="O3" value="24.81" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Both eyes used in the analysis controlling for the correlation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <p_value_desc>Adjusted for multiple comparisons</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.62</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Three years</time_frame>
      <desc>Any event, ocular or non-ocular, regardless of relation to contact lens wear that occurred.</desc>
      <group_list>
        <group group_id="E1">
          <title>Biofinity</title>
          <description>Spherical soft contact lens</description>
        </group>
        <group group_id="E2">
          <title>Biofinity +1.50 D Add</title>
          <description>Medium add soft bifocal contact lens (+1.50 Diopter add)</description>
        </group>
        <group group_id="E3">
          <title>Biofinity +2.50 D Add</title>
          <description>High add soft bifocal contact lens (+2.50 Diopter add)</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="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="97"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="98"/>
                <counts group_id="E3" subjects_affected="75" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>SEAL</sub_title>
                <description>Superior Epithelial Arcuate Lesion</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>CLARE</sub_title>
                <description>Contact lens associated red eye</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Corneal epithelial defect</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Infiltrative keratitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="97"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Probable microbial keratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Sterile Corneal Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Toxic exposure</sub_title>
                <description>gas. soap in eye</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Giant papillary conjunctivitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Ocular allergies</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="97"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="98"/>
                <counts group_id="E3" events="25" subjects_affected="22" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Hordeolum/chalazion</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="97"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E3" events="10" subjects_affected="7" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Eyelash issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Ptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Corneal scar, new</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Solution induced corneal staining</sub_title>
                <counts group_id="E1" events="28" subjects_affected="28" subjects_at_risk="97"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="98"/>
                <counts group_id="E3" events="28" subjects_affected="28" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Poor contact lens fit</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="97"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Contact lens solution issue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Conjunctivitis, any type</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="97"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Subconjunctival hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Retinal issue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Optic nerve issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Trauma, ocular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Binocular vision/accommodation issue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Color vision defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Transient visual disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Unspecified contact lens issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Visual symptoms, no obvious cause</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Trauma, non-ocular</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="97"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="98"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Headaches</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="97"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Systemic disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="97"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="98"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Can't categorize</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy, non-ocular</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental health issues</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="97"/>
              </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>Dr. Jeffrey Walline</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-247-6840</phone>
      <email>walline.1@osu.edu</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/NCT02255474
org study id: 2014H0231
secondary id: U10EY023208
nct id: NCT02255474
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study will evaluate the use of two different bifocal contact lens add powers to prevent
      further nearsighted progression in children ages 7 to 11 years old. It is theorized that the
      profile of the bifocal lenses will decrease the amount of change in nearsightedness that the
      children experience.
The primary goal of this project is to determine whether a commercially available soft
      bifocal contact lens with a distance-center design can slow myopia progression in children.
      Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel
      use for a standard contact lens that may keep children from becoming as nearsighted as they
      would otherwise. Secondary goals are to determine whether the amount of myopic defocus
      imposed on the peripheral retina by soft bifocal contact lenses is associated in a
      dose-dependent manner with slowed myopic progression and to determine whether peripheral
      myopic blur acts to slow eye growth locally or globally. These important pieces of
      information will enable investigators to learn about the role of peripheral optics for
      regulating eye growth, which could ultimately lead to optimization of optical signals to slow
      myopia progression. Ultimately, the information could be used to design optical devices to
      prevent the onset of myopia in young children.

      Slowing myopia progression or eventually preventing myopia onset could potentially affect
      approximately 60 million children in the United States alone. While the consequences of
      myopia are rarely sight-threatening, the quality of life for myopic patients is negatively
      affected and the health care costs to treat myopia are astronomical (approximately $4.6
      billion in 1990). The National Eye Institute recognizes the need to "evaluate the efficacy of
      potential treatments for delaying the onset or for slowing the progression of myopia, such as
      lenses that alter peripheral defocus."

      Using a common treatment of myopia (contact lenses) to potentially slow myopia progression
      and to learn about optical signals that regulate eye growth is a very novel approach to
      solving a problem that affects a large proportion of people in the United States.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Refractive Error Progression
time frame: 3 years
description: Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
measure: Ocular Shape Change and Eye Growth
time frame: 3 years
description: The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).
measure: Association of Peripheral Defocus to Myopic Progression
time frame: 3 years
description: Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).
measure: Axial Length Progression
time frame: 3 years
description: Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
arm group label: Biofinity
arm group type: Active Comparator
description: Soft spherical contact lens
arm group label: Biofinity Multifocal D +1.50 add
arm group type: Experimental
description: The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power
arm group label: Biofinity Multifocal D +2.50 add
arm group type: Experimental
description: The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power
intervention type: Device
intervention name: Biofinity Multifocal D +1.50 add
description: This is a monthly disposable contact lens commercially available from CooperVision
arm group label: Biofinity Multifocal D +1.50 add
intervention type: Device
intervention name: Biofinity Multifocal D +2.50 add
description: This is a monthly disposable contact lens commercially available from CooperVision
arm group label: Biofinity Multifocal D +2.50 add
intervention type: Device
intervention name: Biofinity
description: This is a monthly disposable spherical contact lens commercially available from CooperVision
arm group label: Biofinity
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: No
last name: Jeffrey Walline, OD, PhD
role: Study Chair
affiliation: Ohio State University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Jeffrey J. Walline, OD PhD
investigator title: Associate Professor
mesh term: Refractive Errors
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 