<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/NCT02193178</url>
  </required_header>
  <id_info>
    <org_study_id>CV-14-05</org_study_id>
    <nct_id>NCT02193178</nct_id>
  </id_info>
  <brief_title>Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges</brief_title>
  <official_title>Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges</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 that the Biofinity Toric XR lenses will perform as well as or better&#xD;
      than the participants' habitual contact lenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better&#xD;
      than the participants' habitual contact lenses. Further, that a minimum of 80% of those&#xD;
      enrolled will complete 2 weeks of lens wear with no contraindication to continue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Comfort</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Vision</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post</time_frame>
    <description>Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Handling</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Satisfaction</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Rotation</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Overall Stability</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Palpebral Hyperemia and Roughness</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Bulbar and Limbal Redness</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Corneal Staining</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= &gt;45% of area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior Ocular Health - Conjunctival Staining and Indentation</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
    <description>Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Preference - Comfort</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference - Vision</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference - Handling</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Preference</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator Acceptability</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>comfilcon A toric</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comfilcon A Toric</intervention_name>
    <description>Contact lenses</description>
    <arm_group_label>comfilcon A toric</arm_group_label>
    <other_name>Biofinity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has had an 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 20/50 or better (in at least one eye)&#xD;
&#xD;
          -  Currently wears soft toric contact lenses in both eyes&#xD;
&#xD;
          -  Subject contact lens prescription must fall under one of the contact lens power ranges&#xD;
             for at least one eye:&#xD;
&#xD;
               -  -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25&#xD;
&#xD;
               -  +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25&#xD;
&#xD;
               -  -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75&#xD;
&#xD;
               -  -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75&#xD;
&#xD;
               -  +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Demonstrates an acceptable fit with the study lenses&#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 abnormality that would affect the wearing of contact&#xD;
             lenses;&#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>Jan Bergmanson, OD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pete Kollbaum, OD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston</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>July 2020</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>August 2, 2016</results_first_submitted>
  <results_first_submitted_qc>December 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2017</results_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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>Overall Participants</title>
          <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dry eyes</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant discontinued and therefore data was not included in analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Baseline Characteristics</title>
          <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <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="29" spread="11"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Comfort</title>
        <description>Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Comfort</title>
          <description>Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.</description>
          <population>One participant discontinued and therefore data was not included in analysis.</population>
          <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="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" spread="16"/>
                    <measurement group_id="O2" value="91" spread="9"/>
                    <measurement group_id="O3" value="88" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Vision</title>
        <description>Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Vision</title>
          <description>Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.</description>
          <population>One participant discontinued and therefore data was not included in analysis.</population>
          <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="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="17"/>
                    <measurement group_id="O2" value="85" spread="15"/>
                    <measurement group_id="O3" value="80" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Handling</title>
        <description>Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Handling</title>
          <description>Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy</description>
          <population>One participant discontinued and therefore data was not included in analysis.</population>
          <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="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="25"/>
                    <measurement group_id="O2" value="89" spread="16"/>
                    <measurement group_id="O3" value="94" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Satisfaction</title>
        <description>Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Satisfaction</title>
          <description>Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.</description>
          <population>One participant discontinued and therefore data was not included in analysis.</population>
          <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="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" spread="10"/>
                    <measurement group_id="O2" value="92" spread="9"/>
                    <measurement group_id="O3" value="89" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Rotation</title>
        <description>Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Rotation</title>
          <description>Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.</description>
          <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 degrees</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=5 degrees</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=10 degrees</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="86"/>
                    <measurement group_id="O3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=15 degrees</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="93"/>
                    <measurement group_id="O3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;15 degrees</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Overall Stability</title>
        <description>Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Overall Stability</title>
          <description>Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability</description>
          <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.7"/>
                    <measurement group_id="O2" value="3.3" spread="0.8"/>
                    <measurement group_id="O3" value="3.3" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit Acceptance</title>
        <description>General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)</description>
          <population>One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.6"/>
                    <measurement group_id="O2" value="3.5" spread="0.7"/>
                    <measurement group_id="O3" value="3.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Palpebral Hyperemia and Roughness</title>
        <description>Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Palpebral Hyperemia and Roughness</title>
          <description>Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Palpebral Conjunctival Hyperemia (Superior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.81"/>
                    <measurement group_id="O2" value="0.48" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctival Hyperemia (Inferior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.60"/>
                    <measurement group_id="O2" value="0.50" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctival Papillae (Superior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.46"/>
                    <measurement group_id="O2" value="0.58" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctival Papillae (Inferior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.43"/>
                    <measurement group_id="O2" value="0.54" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Bulbar and Limbal Redness</title>
        <description>Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Bulbar and Limbal Redness</title>
          <description>Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bulbar (nasal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.71"/>
                    <measurement group_id="O2" value="0.67" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar (temporal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.75"/>
                    <measurement group_id="O2" value="0.67" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar (superior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.76"/>
                    <measurement group_id="O2" value="0.63" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar (inferior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.76"/>
                    <measurement group_id="O2" value="0.62" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal (nasal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="1.07"/>
                    <measurement group_id="O2" value="0.21" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal (temporal)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="1.07"/>
                    <measurement group_id="O2" value="0.21" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal (superior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="1.06"/>
                    <measurement group_id="O2" value="0.21" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal (inferior)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="1.09"/>
                    <measurement group_id="O2" value="0.19" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Corneal Staining</title>
        <description>Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= &gt;45% of area</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Corneal Staining</title>
          <description>Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. 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>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central</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>Nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.31"/>
                    <measurement group_id="O2" value="0.04" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporal</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>Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.19"/>
                    <measurement group_id="O2" value="0.04" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.31"/>
                    <measurement group_id="O2" value="0.12" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anterior Ocular Health - Conjunctival Staining and Indentation</title>
        <description>Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conjunctival Staining (Baseline)</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Conjunctival Indentation (Baseline)</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Conjunctival Staining (2 Weeks)</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O4">
            <title>Conjunctival Indentation (2 Weeks)</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Anterior Ocular Health - Conjunctival Staining and Indentation</title>
          <description>Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.51"/>
                    <measurement group_id="O2" value="0.21" spread="0.40"/>
                    <measurement group_id="O3" value="0.54" spread="0.49"/>
                    <measurement group_id="O4" value="0.37" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.40"/>
                    <measurement group_id="O2" value="0.11" spread="0.31"/>
                    <measurement group_id="O3" value="0.29" spread="0.51"/>
                    <measurement group_id="O4" value="0.38" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.18"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.15" spread="0.31"/>
                    <measurement group_id="O4" value="0.02" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.43"/>
                    <measurement group_id="O2" value="0.13" spread="0.35"/>
                    <measurement group_id="O3" value="0.19" spread="0.38"/>
                    <measurement group_id="O4" value="0.21" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity</title>
        <description>Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.</description>
        <time_frame>2 weeks prior to baseline, Baseline, 2 weeks post baseline</time_frame>
        <population>One participant discontinued and therefore data was not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Habitual Lenses</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O3">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity</title>
          <description>Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.</description>
          <population>One participant discontinued and therefore data was not included in analysis.</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>High Contrast High Illumination (monocular)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.14"/>
                    <measurement group_id="O2" value="0.06" spread="0.08"/>
                    <measurement group_id="O3" value="0.07" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Contrast High Illumination (binocular)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.09"/>
                    <measurement group_id="O2" value="0.00" spread="0.07"/>
                    <measurement group_id="O3" value="-0.03" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Contrast Low Illumination (monocular)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.13"/>
                    <measurement group_id="O2" value="0.20" spread="0.09"/>
                    <measurement group_id="O3" value="0.23" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Contrast Low Illumination (binocular)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.09"/>
                    <measurement group_id="O2" value="0.15" spread="0.10"/>
                    <measurement group_id="O3" value="0.17" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Preference - Comfort</title>
        <description>Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A- Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A-2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Preference - Comfort</title>
          <description>Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</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="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>comfilcon A lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Habitual lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Preference - Vision</title>
        <description>Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Preference - Vision</title>
          <description>Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</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="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>comfilcon A XR lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Habitual lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Preference - Handling</title>
        <description>Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <population>Missing data for handling preference for one participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A- Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Preference - Handling</title>
          <description>Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
          <population>Missing data for handling preference for one participant.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>comfilcon A lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Habitual lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Preference</title>
        <description>Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A - 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Preference</title>
          <description>Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses</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="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>comfilcon A lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Habitual lenses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Investigator Acceptability</title>
        <description>Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A Baseline</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
          <group group_id="O2">
            <title>Comfilcon A 2 Weeks</title>
            <description>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Acceptability</title>
          <description>Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.</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="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither Agree nor Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to two weeks for each study lenses</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comfilcon A Toric XR MTO</title>
          <description>Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.&#xD;
comfilcon A Toric XR (MTO) contact lenses</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="15"/>
              </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="15"/>
              </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/NCT02193178
org study id: CV-14-05
nct id: NCT02193178
lead sponsor: 
has dmc: No
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better
      than the participants' habitual contact lenses.
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better
      than the participants' habitual contact lenses. Further, that a minimum of 80% of those
      enrolled will complete 2 weeks of lens wear with no contraindication to continue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Comfort
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
measure: Overall Vision
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post
description: Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
measure: Handling
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
measure: Overall Satisfaction
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
measure: Lens Fit - Rotation
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
measure: Lens Fit - Overall Stability
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
measure: Lens Fit Acceptance
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
measure: Anterior Ocular Health - Palpebral Hyperemia and Roughness
time frame: Baseline and 2 weeks
description: Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
measure: Anterior Ocular Health - Bulbar and Limbal Redness
time frame: Baseline and 2 weeks
description: Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
measure: Anterior Ocular Health - Corneal Staining
time frame: Baseline and 2 weeks
description: Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
measure: Anterior Ocular Health - Conjunctival Staining and Indentation
time frame: Baseline and 2 weeks
description: Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
measure: Visual Acuity
time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
description: Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
measure: Subjective Preference - Comfort
time frame: Baseline and 2 weeks
description: Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
measure: Preference - Vision
time frame: Baseline and 2 weeks
description: Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
measure: Preference - Handling
time frame: Baseline and 2 weeks
description: Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
measure: Overall Preference
time frame: Baseline and 2 weeks
description: Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
measure: Investigator Acceptability
time frame: Baseline and 2 weeks
description: Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
arm group label: comfilcon A toric
arm group type: Experimental
description: Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
intervention type: Device
intervention name: comfilcon A Toric
description: Contact lenses
arm group label: comfilcon A toric
other name: Biofinity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Bergmanson, OD PhD
role: Principal Investigator
affiliation: Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
last name: Pete Kollbaum, OD PhD
role: Principal Investigator
affiliation: Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 