<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/NCT02185105</url>
  </required_header>
  <id_info>
    <org_study_id>CV-14-04</org_study_id>
    <nct_id>NCT02185105</nct_id>
  </id_info>
  <brief_title>Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses</brief_title>
  <official_title>Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis is there is no difference in the clinical performance between the test&#xD;
      and control lenses, in particular in lens stability, toric mislocation, comfort ratings and&#xD;
      anterior segment ocular health findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial&#xD;
      Biofinity toric lenses over 6 hours of lens wear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lens Surface Assessment of Study Lenses - Surface Wettability</measure>
    <time_frame>15min &amp; 6hrs</time_frame>
    <description>Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Surface Assessment of Study Lenses - Deposits</measure>
    <time_frame>15min &amp; 6hrs</time_frame>
    <description>Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film &gt; 75% of surface)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Surface Assessment of Study Lenses - Surface Acceptance</measure>
    <time_frame>15min &amp; 6hrs</time_frame>
    <description>Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Rating For Comfort - Comfort Since Last Visit</measure>
    <time_frame>15min, 3hrs, 6hrs</time_frame>
    <description>Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Rating For Comfort Preference</measure>
    <time_frame>1min, 15min, 3hrs, 6hrs</time_frame>
    <description>Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Rating For Handling - Insertion</measure>
    <time_frame>1 min</time_frame>
    <description>Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Rating For Handling - Removal</measure>
    <time_frame>1 min</time_frame>
    <description>Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator's Assessment of Stability</measure>
    <time_frame>15min &amp; 6hrs</time_frame>
    <description>Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Lens Fit - Fit Acceptance</measure>
    <time_frame>15min &amp; 6hrs</time_frame>
    <description>Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fitting - Rotation/Mislocation</measure>
    <time_frame>Baseline, 15min &amp; 6hrs</time_frame>
    <description>Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Corneal Staining (Central)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Corneal Staining (Nasal)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Corneal Staining (Temporal)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - CornealStaining (Superior)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Corneal Staining (Inferior)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Conjunctival Staining (Nasal)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Conjunctival Staining (Superior)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Conjunctival Staining (Temporal)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Conjunctival Staining (Inferior)</measure>
    <time_frame>baseline &amp; 6hrs</time_frame>
    <description>Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>comfilcon A MTO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>comfilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comfilcon A MTO</intervention_name>
    <description>Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
    <arm_group_label>comfilcon A</arm_group_label>
    <other_name>Biofinity Toric MTO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comfilcon A</intervention_name>
    <description>Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
    <arm_group_label>comfilcon A MTO</arm_group_label>
    <other_name>Biofinity Toric</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has had a self-reported oculo-visual examination in the last two years.&#xD;
&#xD;
          -  Is at least 18 years of age and has full legal capacity to volunteer.&#xD;
&#xD;
          -  Has read and understood the information consent letter.&#xD;
&#xD;
          -  Is willing and able to follow instructions and maintain the appointment schedule.&#xD;
&#xD;
          -  Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual&#xD;
             vision correction or 20/20 best-corrected.&#xD;
&#xD;
          -  Currently wears soft contact lenses.&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease.&#xD;
&#xD;
          -  Has not worn lenses for at least 12 hours before the examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has never worn contact lenses before.&#xD;
&#xD;
          -  Has any systemic disease affecting ocular health.&#xD;
&#xD;
          -  Is using any systemic or topical medications that will affect ocular health.&#xD;
&#xD;
          -  Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to&#xD;
             severe dry eyes) that would affect the wearing of contact lenses.&#xD;
&#xD;
          -  Has persistent, clinically significant corneal or conjunctival staining using sodium&#xD;
             fluorescein dye.&#xD;
&#xD;
          -  Has any clinically significant lid or conjunctival abnormalities, active&#xD;
             neovascularization or any central corneal scars.&#xD;
&#xD;
          -  Is aphakic.&#xD;
&#xD;
          -  Has undergone corneal refractive surgery.&#xD;
&#xD;
          -  Is participating in any other type of eye related clinical or research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pete S Kollbaum, O.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CORL, Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>August 2, 2016</results_first_submitted>
  <results_first_submitted_qc>November 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 2, 2017</results_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric</title>
          <description>Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric</title>
          <description>Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" 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="25" spread="8"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lens Surface Assessment of Study Lenses - Surface Wettability</title>
        <description>Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)</description>
        <time_frame>15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR (Extended Range) Toric</title>
            <description>Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
            <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface Assessment of Study Lenses - Surface Wettability</title>
          <description>Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.3"/>
                    <measurement group_id="O2" value="3.4" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.4"/>
                    <measurement group_id="O2" value="3.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Surface Assessment of Study Lenses - Deposits</title>
        <description>Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film &gt; 75% of surface)</description>
        <time_frame>15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
            <description>Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
            <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface Assessment of Study Lenses - Deposits</title>
          <description>Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film &gt; 75% of surface)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.18"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Surface Assessment of Study Lenses - Surface Acceptance</title>
        <description>Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)</description>
        <time_frame>15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
            <description>Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
            <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface Assessment of Study Lenses - Surface Acceptance</title>
          <description>Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.4"/>
                    <measurement group_id="O2" value="3.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.5"/>
                    <measurement group_id="O2" value="3.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Rating For Comfort - Comfort Since Last Visit</title>
        <description>Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)</description>
        <time_frame>15min, 3hrs, 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Subjective Rating For Comfort - Comfort Since Last Visit</title>
          <description>Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="11"/>
                    <measurement group_id="O2" value="90" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="17"/>
                    <measurement group_id="O2" value="87" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="15"/>
                    <measurement group_id="O2" value="88" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Rating For Comfort Preference</title>
        <description>Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)</description>
        <time_frame>1min, 15min, 3hrs, 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
          <group group_id="O3">
            <title>No Preference</title>
          </group>
        </group_list>
        <measure>
          <title>Subjective Rating For Comfort Preference</title>
          <description>Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 minute</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Rating For Handling - Insertion</title>
        <description>Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)</description>
        <time_frame>1 min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Subjective Rating For Handling - Insertion</title>
          <description>Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" spread="7"/>
                    <measurement group_id="O2" value="95" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Rating For Handling - Removal</title>
        <description>Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)</description>
        <time_frame>1 min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Subjective Rating For Handling - Removal</title>
          <description>Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" spread="38"/>
                    <measurement group_id="O2" value="74" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Investigator's Assessment of Stability</title>
        <description>Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.</description>
        <time_frame>15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Investigator's Assessment of Stability</title>
          <description>Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="4"/>
                    <measurement group_id="O2" value="3" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="3"/>
                    <measurement group_id="O2" value="4" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>General Lens Fit - Fit Acceptance</title>
        <description>Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)</description>
        <time_frame>15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>General Lens Fit - Fit Acceptance</title>
          <description>Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.2"/>
                    <measurement group_id="O2" value="3.4" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.2"/>
                    <measurement group_id="O2" value="3.4" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fitting - Rotation/Mislocation</title>
        <description>Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).</description>
        <time_frame>Baseline, 15min &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Lens Fitting - Rotation/Mislocation</title>
          <description>Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="5"/>
                    <measurement group_id="O2" value="3" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="6"/>
                    <measurement group_id="O2" value="1" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="5"/>
                    <measurement group_id="O2" value="-1" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Corneal Staining (Central)</title>
        <description>Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Corneal Staining (Central)</title>
          <description>Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.09"/>
                    <measurement group_id="O2" value="0.02" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Corneal Staining (Nasal)</title>
        <description>Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Corneal Staining (Nasal)</title>
          <description>Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.09"/>
                    <measurement group_id="O2" value="0.05" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Corneal Staining (Temporal)</title>
        <description>Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Corneal Staining (Temporal)</title>
          <description>Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.09"/>
                    <measurement group_id="O2" value="0.05" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - CornealStaining (Superior)</title>
        <description>Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - CornealStaining (Superior)</title>
          <description>Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.03" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.09"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Corneal Staining (Inferior)</title>
        <description>Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Corneal Staining (Inferior)</title>
          <description>Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= &gt;45% of area)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.31"/>
                    <measurement group_id="O2" value="0.05" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.35"/>
                    <measurement group_id="O2" value="0.28" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Conjunctival Staining (Nasal)</title>
        <description>Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Conjunctival Staining (Nasal)</title>
          <description>Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.41"/>
                    <measurement group_id="O2" value="0.13" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.41"/>
                    <measurement group_id="O2" value="0.23" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Conjunctival Staining (Superior)</title>
        <description>Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Conjunctival Staining (Superior)</title>
          <description>Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.03" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Conjunctival Staining (Temporal)</title>
        <description>Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Conjunctival Staining (Temporal)</title>
          <description>Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.25"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.25"/>
                    <measurement group_id="O2" value="0.13" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Conjunctival Staining (Inferior)</title>
        <description>Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
        <time_frame>baseline &amp; 6hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comflicon A XR Toric (Extended Range)</title>
          </group>
          <group group_id="O2">
            <title>Comfilcon A Toric</title>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Conjunctival Staining (Inferior)</title>
          <description>Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.18"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.31"/>
                    <measurement group_id="O2" value="0.10" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Comfilcon A MTO</title>
          <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
        </group>
        <group group_id="E2">
          <title>Comfilcon A</title>
          <description>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.&#xD;
comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Principal Investigators are NOT employed by the organization sponsoring the study.&#xD;
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.&#xD;
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sr. Manager, Clinical Research</name_or_title>
      <organization>CooperVision, Inc</organization>
      <phone>9257306754</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/NCT02185105
org study id: CV-14-04
nct id: NCT02185105
lead sponsor: 
has dmc: No
The study hypothesis is there is no difference in the clinical performance between the test
      and control lenses, in particular in lens stability, toric mislocation, comfort ratings and
      anterior segment ocular health findings.
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial
      Biofinity toric lenses over 6 hours of lens wear.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Lens Surface Assessment of Study Lenses - Surface Wettability
time frame: 15min & 6hrs
description: Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
measure: Lens Surface Assessment of Study Lenses - Deposits
time frame: 15min & 6hrs
description: Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)
measure: Lens Surface Assessment of Study Lenses - Surface Acceptance
time frame: 15min & 6hrs
description: Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
measure: Subjective Rating For Comfort - Comfort Since Last Visit
time frame: 15min, 3hrs, 6hrs
description: Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
measure: Subjective Rating For Comfort Preference
time frame: 1min, 15min, 3hrs, 6hrs
description: Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
measure: Subjective Rating For Handling - Insertion
time frame: 1 min
description: Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
measure: Subjective Rating For Handling - Removal
time frame: 1 min
description: Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
measure: Investigator's Assessment of Stability
time frame: 15min & 6hrs
description: Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
measure: General Lens Fit - Fit Acceptance
time frame: 15min & 6hrs
description: Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
measure: Lens Fitting - Rotation/Mislocation
time frame: Baseline, 15min & 6hrs
description: Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
measure: Anterior Ocular Health - Corneal Staining (Central)
time frame: baseline & 6hrs
description: Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
measure: Anterior Ocular Health - Corneal Staining (Nasal)
time frame: baseline & 6hrs
description: Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
measure: Anterior Ocular Health - Corneal Staining (Temporal)
time frame: baseline & 6hrs
description: Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
measure: Anterior Ocular Health - CornealStaining (Superior)
time frame: baseline & 6hrs
description: Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
measure: Anterior Ocular Health - Corneal Staining (Inferior)
time frame: baseline & 6hrs
description: Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
measure: Anterior Ocular Health - Conjunctival Staining (Nasal)
time frame: baseline & 6hrs
description: Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
measure: Anterior Ocular Health - Conjunctival Staining (Superior)
time frame: baseline & 6hrs
description: Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
measure: Anterior Ocular Health - Conjunctival Staining (Temporal)
time frame: baseline & 6hrs
description: Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
measure: Anterior Ocular Health - Conjunctival Staining (Inferior)
time frame: baseline & 6hrs
description: Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
arm group label: comfilcon A MTO
arm group type: Experimental
description: Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
arm group label: comfilcon A
arm group type: Active Comparator
description: Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
intervention type: Device
intervention name: comfilcon A MTO
description: Randomized to a test lens in one eye and control lens in the other as a matched pair.
arm group label: comfilcon A
other name: Biofinity Toric MTO
intervention type: Device
intervention name: comfilcon A
description: Randomized to a test lens in one eye and control lens in the other as a matched pair.
arm group label: comfilcon A MTO
other name: Biofinity Toric
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pete S Kollbaum, O.D.
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 