<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/NCT03835221</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-96</org_study_id>
    <nct_id>NCT03835221</nct_id>
  </id_info>
  <brief_title>Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month</brief_title>
  <official_title>Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month</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 toric lenses after a refit with fanfilcon A toric lenses for 1-month 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>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens centration was assessed on a 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 Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal coverage was 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Corneal coverage was 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 Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal coverage was 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 Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Corneal coverage was 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Corneal coverage was 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 Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Post-blink movement was assessed on a 0-4 scale (where: 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses</measure>
    <time_frame>2 weeks</time_frame>
    <description>Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Overall lens fit acceptance assessed using grade (0-4) 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 Toric 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 Toric 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 Toric 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 Toric 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 Toric 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 Toric 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">43</enrollment>
  <condition>Ametropia</condition>
  <arm_group>
    <arm_group_label>methafilcon A toric / fanfilcon A toric contact lenses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then 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 toric contact lenses</intervention_name>
    <description>Bilateral daily wear of methafilcon A toric contact lenses</description>
    <arm_group_label>methafilcon A toric / fanfilcon A toric contact lenses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fanfilcon A toric contact lenses</intervention_name>
    <description>Bilateral daily wear of fanfilcon A toric contact lenses</description>
    <arm_group_label>methafilcon A toric / fanfilcon A toric 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 +6.00 to - 8.00 (inclusive)-Have no&#xD;
             less than -0.75D of astigmatism and no more than -2.25 D 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 less than -0.75D or more than -2.50 D of cylinder in either&#xD;
             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;
&#xD;
          -  Has a known history of corneal hypoesthesia (reduced corneal sensitivity)&#xD;
&#xD;
          -  Has aphakia, keratoconus or a highly irregular cornea&#xD;
&#xD;
          -  Has Presbyopia or has dependence on spectacles for near work over the contact lenses&#xD;
&#xD;
          -  Has undergone corneal refractive surgery&#xD;
&#xD;
          -  Is participating in any other type of eye related clinical or research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>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 11, 2020</results_first_submitted>
  <results_first_submitted_qc>May 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2020</results_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 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 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03835221/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Methafilcon A / Fanfilcon A Contact Lenses</title>
          <description>All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A 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>Methafilcon A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Fanfilcon A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </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="43"/>
          </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="43"/>
                  </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="43"/>
                  </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="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.2" spread="6.9"/>
                  </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="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </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="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Lens centration was assessed on a 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>Methafilcon A</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>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal Centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </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>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Lens centration was assessed on a 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>Methafilcon A</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>Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decentration acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens centration was assessed on a 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</title>
            <description>All subjects will wear fanfilcon A 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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens centration was assessed on a 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</title>
            <description>All subjects will wear fanfilcon A 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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens centration was assessed on a 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</title>
            <description>All subjects will wear fanfilcon A 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>Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Optimal centration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </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 Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Corneal coverage was 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Corneal coverage was 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="43"/>
              </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 - Methafilcon A Toric Contact Lenses</title>
        <description>Corneal coverage was 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Corneal coverage was 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="42"/>
              </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 Toric Contact Lenses</title>
        <description>Corneal coverage was 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Corneal coverage was 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="42"/>
              </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 Toric Contact Lenses</title>
        <description>Corneal coverage was 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Corneal coverage was 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="42"/>
              </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 Toric Contact Lenses</title>
        <description>Corneal coverage was 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Corneal coverage was 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="42"/>
              </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 Toric Contact Lenses</title>
        <description>Post-blink movement was assessed on a 0-4 scale (where: 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Post-blink movement was assessed on a 0-4 scale (where: 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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Post-blink movement was assessed on a 0-4 scale (where: 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Post-blink movement was assessed on a 0-4 scale (where: 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Post-blink movement was assessed on a 0-4 scale (where: 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Post-blink movement was assessed on a 0-4 scale (where: 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Post-blink movement was assessed on a 0-4 scale (where: 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Post-blink movement was assessed on a 0-4 scale (where: 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Post-blink movement was assessed on a 0-4 scale (where: 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Post-blink movement was assessed on a 0-4 scale (where: 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</title>
        <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</title>
          <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</title>
        <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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 Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses</title>
          <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.79" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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>Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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>Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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 Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methafilcon A</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 Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses</title>
          <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fanfilcon A</title>
            <description>All subjects will wear fanfilcon A 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 Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses</title>
          <description>Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" 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 - Methafilcon A Toric Contact Lenses</title>
        <description>Overall lens fit acceptance assessed using grade (0-4) 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Overall lens fit acceptance assessed using grade (0-4) 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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses</title>
        <description>Overall lens fit acceptance assessed using grade (0-4) 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>Methafilcon A</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 Toric Contact Lenses</title>
          <description>Overall lens fit acceptance assessed using grade (0-4) 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses</title>
        <description>Overall lens fit acceptance assessed using grade (0-4) 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Overall lens fit acceptance assessed using grade (0-4) 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" 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 Toric Contact Lenses</title>
        <description>Overall lens fit acceptance assessed using grade (0-4) 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Overall lens fit acceptance assessed using grade (0-4) 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" 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 Toric Contact Lenses</title>
        <description>Overall lens fit acceptance assessed using grade (0-4) 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric Contact Lenses</title>
          <description>Overall lens fit acceptance assessed using grade (0-4) 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Methafilcon A Toric 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>Methafilcon A</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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Fanfilcon A Toric 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Wearing Time - Fanfilcon A Toric 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Methafilcon A Toric 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>Methafilcon A</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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Fanfilcon A Toric 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Comfortable Wearing Time - Fanfilcon A Toric 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</title>
            <description>All subjects will wear fanfilcon A 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 Toric 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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.1"/>
                  </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 Toric Contact Lenses</title>
          <description>All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
methafilcon A toric contact lenses: Bilateral daily wear of methafilcon A toric contact lenses</description>
        </group>
        <group group_id="E2">
          <title>Fanfilcon A Toric Contact Lenses</title>
          <description>All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.&#xD;
fanfilcon A toric contact lenses: Bilateral daily wear of fanfilcon A toric contact lenses</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </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/NCT03835221
org study id: EX-MKTG-96
nct id: NCT03835221
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 toric lenses after a refit with fanfilcon A toric lenses for 1-month 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: Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: Baseline
description: Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: Baseline
description: Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens centration was assessed on a 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 Toric Contact Lenses
time frame: Baseline
description: Corneal coverage was 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 Toric Contact Lenses
time frame: 4 weeks
description: Corneal coverage was 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 Toric Contact Lenses
time frame: Baseline
description: Corneal coverage was 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 Toric Contact Lenses
time frame: 2 weeks
description: Corneal coverage was 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 Toric Contact Lenses
time frame: 4 weeks
description: Corneal coverage was 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 Toric Contact Lenses
time frame: Baseline
description: Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses
time frame: 4 weeks
description: Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses
time frame: Baseline
description: Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses
time frame: 2 weeks
description: Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses
time frame: 4 weeks
description: Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
time frame: Baseline
description: Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: Baseline
description: Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
measure: Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: Baseline
description: Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
measure: Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: Baseline
description: Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
measure: Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: Baseline
description: Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
measure: Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
time frame: 4 weeks
description: Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: Baseline
description: Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
measure: Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
time frame: Baseline
description: Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses
time frame: 4 weeks
description: Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses
time frame: Baseline
description: Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses
time frame: 2 weeks
description: Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses
time frame: 4 weeks
description: Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses
time frame: 4 weeks
description: Average daily wearing time response by the subject
measure: Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Average daily wearing time response by the subject
measure: Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Average daily wearing time response by the subject
measure: Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses
time frame: 4 weeks
description: Average comfortable wearing time - response by the subject
measure: Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
time frame: 2 weeks
description: Average comfortable wearing time - response by the subject
measure: Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
time frame: 4 weeks
description: Average comfortable wearing time - response by the subject
arm group label: methafilcon A toric / fanfilcon A toric contact lenses
arm group type: Experimental
description: All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.
intervention type: Device
intervention name: methafilcon A toric contact lenses
description: Bilateral daily wear of methafilcon A toric contact lenses
arm group label: methafilcon A toric / fanfilcon A toric contact lenses
intervention type: Device
intervention name: fanfilcon A toric contact lenses
description: Bilateral daily wear of fanfilcon A toric contact lenses
arm group label: methafilcon A toric / fanfilcon A toric 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: 