<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/NCT03835078</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-98</org_study_id>
    <nct_id>NCT03835078</nct_id>
  </id_info>
  <brief_title>Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks</brief_title>
  <official_title>Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective study is to evaluate the clinical performance of habitual wearers&#xD;
      of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of&#xD;
      daily wear.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 27, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Daily Wearing Time - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Average daily wearing time response by the subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Daily Wearing Time - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average daily wearing time response by the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Daily Wearing Time - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Average daily wearing time response by the subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Comfortable Wearing Time - Methafilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Average comfortable wearing time - response by the subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Average comfortable wearing time - response by the subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Average comfortable wearing time - response by the subject</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Ametropia</condition>
  <arm_group>
    <arm_group_label>methalfilcon A contact lenses / fanfilcon A contact lenses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>methafilcon A contact lenses</intervention_name>
    <description>Bilateral daily wear of methafilcon A contact lenses</description>
    <arm_group_label>methalfilcon A contact lenses / fanfilcon A contact lenses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fanfilcon A contact lenses</intervention_name>
    <description>Bilateral daily wear of fanfilcon A contact lenses</description>
    <arm_group_label>methalfilcon A contact lenses / fanfilcon A contact lenses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is between 18 and 40 years of age (inclusive)&#xD;
&#xD;
          -  Has had a self-reported visual exam in the last two years&#xD;
&#xD;
          -  Is an adapted soft contact lens wearer&#xD;
&#xD;
          -  Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)&#xD;
&#xD;
          -  Have no less than -0.75D (Diopter) of astigmatism in both eyes&#xD;
&#xD;
          -  Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or&#xD;
             better in each eye.&#xD;
&#xD;
          -  Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with&#xD;
             the study contact lenses.&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Has read, understood and signed the information consent letter&#xD;
&#xD;
          -  Patient contact lens refraction should fit within the available parameters of the&#xD;
             study lenses&#xD;
&#xD;
          -  Is willing to comply with the wear schedule (at least 5 days per week, &gt;8 hours/day&#xD;
             assuming there are no contraindications for doing so)&#xD;
&#xD;
          -  Is willing to comply with the visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a Contact Lens (CL) prescription outside the range of the available parameters of&#xD;
             the study lenses&#xD;
&#xD;
          -  Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye&#xD;
&#xD;
          -  Has a history of not achieving comfortable Contact Lens (CL) wear (5 days per week; &gt;&#xD;
             8 hours/day)&#xD;
&#xD;
          -  Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in&#xD;
             either eye&#xD;
&#xD;
          -  Presence of clinically significant (grade 2-4) anterior segment abnormalities&#xD;
&#xD;
          -  Presence of ocular or systemic disease or need of medications which might interfere&#xD;
             with contact lens wear&#xD;
&#xD;
          -  Slit lamp findings that would contraindicate contact lens wear such as:&#xD;
&#xD;
               -  Pathological dry eye or associated findings&#xD;
&#xD;
               -  Pterygium, pinguecula, or corneal scars within the visual axis&#xD;
&#xD;
               -  Neovascularization &gt; 0.75 mm in from of the limbus&#xD;
&#xD;
               -  Giant papillary conjunctivitis (GCP) worse than grade 1&#xD;
&#xD;
               -  Anterior uveitis or iritis (past or present)&#xD;
&#xD;
               -  Seborrheic eczema, Seborrheic conjunctivitis&#xD;
&#xD;
               -  History of corneal ulcers or fungal infections&#xD;
&#xD;
               -  Poor personal hygiene&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruben Velazquez, MSc FIACLE</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Optometry, National Autonomous University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Optometry Clinic, National Autonomous University</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>May 12, 2020</results_first_submitted>
  <results_first_submitted_qc>May 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2020</results_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 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>Refractive Errors</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03835078/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Methalfilcon A Contact Lenses / Fanfilcon A Contact Lenses</title>
          <description>All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact 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="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </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>Overall Study</title>
          <description>Total Participants</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="39"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3" spread="6.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mexico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentartion Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentartion Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.90" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.59" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.31" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.38" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.64" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.51" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</title>
        <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses</title>
          <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.97" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.92" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
        <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses</title>
          <description>Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Methafilcon A Contact Lenses</title>
        <description>Average daily wearing time response by the subject</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily Wearing Time - Methafilcon A Contact Lenses</title>
          <description>Average daily wearing time response by the subject</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Fanfilcon A Contact Lenses</title>
        <description>Average daily wearing time response by the subject.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily Wearing Time - Fanfilcon A Contact Lenses</title>
          <description>Average daily wearing time response by the subject.</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Fanfilcon A Contact Lenses</title>
        <description>Average daily wearing time response by the subject</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily Wearing Time - Fanfilcon A Contact Lenses</title>
          <description>Average daily wearing time response by the subject</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Methafilcon A Contact Lenses</title>
        <description>Average comfortable wearing time - response by the subject</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methalfilcon A Contact Lenses</title>
            <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Comfortable Wearing Time - Methafilcon A Contact Lenses</title>
          <description>Average comfortable wearing time - response by the subject</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</title>
        <description>Average comfortable wearing time - response by the subject</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</title>
          <description>Average comfortable wearing time - response by the subject</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</title>
        <description>Average comfortable wearing time - response by the subject</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A Contact Lenses</title>
            <description>All subjects will wear fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses</description>
          </group>
        </group_list>
        <measure>
          <title>Average Comfortable Wearing Time - Fanfilcon A Contact Lenses</title>
          <description>Average comfortable wearing time - response by the subject</description>
          <units>hours / day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Methafilcon A</title>
          <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses</description>
        </group>
        <group group_id="E2">
          <title>Fanfilcon A</title>
          <description>All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jose A. Vega, O.D, MSc., FAAO</name_or_title>
      <organization>CooperVision. Inc</organization>
      <phone>9256213761</phone>
      <email>javega@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/NCT03835078
org study id: EX-MKTG-98
nct id: NCT03835078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this prospective study is to evaluate the clinical performance of habitual wearers
      of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of
      daily wear.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
masking description: Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
measure: Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: Baseline
description: Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: Baseline
description: Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: Baseline
description: Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: Baseline
description: Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
measure: Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: Baseline
description: Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: Baseline
description: Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: Baseline
description: Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
measure: Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
measure: Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: Baseline
description: Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
measure: Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
measure: Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
measure: Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
time frame: Baseline
description: Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
measure: Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
time frame: Baseline
description: Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
measure: Average Daily Wearing Time - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Average daily wearing time response by the subject
measure: Average Daily Wearing Time - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Average daily wearing time response by the subject.
measure: Average Daily Wearing Time - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Average daily wearing time response by the subject
measure: Average Comfortable Wearing Time - Methafilcon A Contact Lenses
time frame: 4 weeks
description: Average comfortable wearing time - response by the subject
measure: Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
time frame: 2 weeks
description: Average comfortable wearing time - response by the subject
measure: Average Comfortable Wearing Time - Fanfilcon A Contact Lenses
time frame: 4 weeks
description: Average comfortable wearing time - response by the subject
arm group label: methalfilcon A contact lenses / fanfilcon A contact lenses
arm group type: Experimental
description: All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.
intervention type: Device
intervention name: methafilcon A contact lenses
description: Bilateral daily wear of methafilcon A contact lenses
arm group label: methalfilcon A contact lenses / fanfilcon A contact lenses
intervention type: Device
intervention name: fanfilcon A contact lenses
description: Bilateral daily wear of fanfilcon A contact lenses
arm group label: methalfilcon A contact lenses / fanfilcon A contact lenses
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ruben Velazquez, MSc FIACLE
role: Principal Investigator
affiliation: School of Optometry, National Autonomous University
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Refractive Errors
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 