<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/NCT03024970</url>
  </required_header>
  <id_info>
    <org_study_id>CV-16-60</org_study_id>
    <nct_id>NCT03024970</nct_id>
  </id_info>
  <brief_title>Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens</brief_title>
  <official_title>Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the overall clinical performance of the test&#xD;
      daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A&#xD;
      lens (control).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month&#xD;
      cross-over, dispensing study comparing the test lens against the stenfilcon A control lens&#xD;
      with a study duration of approximately two months.&#xD;
&#xD;
      Each subject will be randomized to wear either the test or control as a matched pair first&#xD;
      and subjects will be randomized based on the order in which the subject is enrolled and&#xD;
      qualified into the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">April 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Ratings on Comfort</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Ratings on Comfort</measure>
    <time_frame>1 Week</time_frame>
    <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Ratings on Comfort</measure>
    <time_frame>1 Month</time_frame>
    <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vision Satisfaction</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vision Satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vision Satisfaction</measure>
    <time_frame>1 Month</time_frame>
    <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On High Illumination High Contrast</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On High Illumination High Contrast</measure>
    <time_frame>1 Week</time_frame>
    <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On High Illumination High Contrast</measure>
    <time_frame>1 Month</time_frame>
    <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On Low Illumination High Contrast</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On Low Illumination High Contrast</measure>
    <time_frame>1 Week</time_frame>
    <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity On Low Illumination High Contrast</measure>
    <time_frame>1 Month</time_frame>
    <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Corneal Staining</measure>
    <time_frame>One Week</time_frame>
    <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Corneal Staining</measure>
    <time_frame>One Month</time_frame>
    <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conjunctival Staining</measure>
    <time_frame>1 Week</time_frame>
    <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conjunctival Staining</measure>
    <time_frame>1 Month</time_frame>
    <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bulbar Hyperemia</measure>
    <time_frame>1 Week</time_frame>
    <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bulbar Hyperemia</measure>
    <time_frame>1 Month</time_frame>
    <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limbal Hyperemia</measure>
    <time_frame>1 Week</time_frame>
    <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limbal Hyperemia</measure>
    <time_frame>1 Month</time_frame>
    <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Palpebral Hyperemia</measure>
    <time_frame>1 Week</time_frame>
    <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Palpebral Hyperemia</measure>
    <time_frame>1 Month</time_frame>
    <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>1 week</time_frame>
    <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>1 Month</time_frame>
    <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling Satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling Satisfaction</measure>
    <time_frame>1 Month</time_frame>
    <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Wettability</measure>
    <time_frame>Baseline</time_frame>
    <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Wettability</measure>
    <time_frame>1 Week</time_frame>
    <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Wettability</measure>
    <time_frame>1 Month</time_frame>
    <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Deposits</measure>
    <time_frame>Baseline</time_frame>
    <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Deposits</measure>
    <time_frame>1 week</time_frame>
    <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Surface - Deposits</measure>
    <time_frame>1 Month</time_frame>
    <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ratings on Dryness</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ratings on Dryness</measure>
    <time_frame>1 week</time_frame>
    <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ratings on Dryness</measure>
    <time_frame>1 Month</time_frame>
    <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>stenfilcon A lens with solution additive (test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stenfilcon A lens (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stenfilcon A lens with solution additive (test)</intervention_name>
    <description>silicone hydrogel lens</description>
    <arm_group_label>stenfilcon A lens (control)</arm_group_label>
    <arm_group_label>stenfilcon A lens with solution additive (test)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stenfilcon A lens (control)</intervention_name>
    <description>contact lens</description>
    <arm_group_label>stenfilcon A lens (control)</arm_group_label>
    <arm_group_label>stenfilcon A lens with solution additive (test)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A person is eligible for inclusion in the study if he/she:&#xD;
&#xD;
               -  Has had a self-reported oculo-visual examination in the last two years.&#xD;
&#xD;
               -  Is at least 18 years of age and has full legal capacity to volunteer.&#xD;
&#xD;
               -  Has read and understood the information consent letter.&#xD;
&#xD;
               -  Is willing and able to follow instructions and maintain the appointment schedule.&#xD;
&#xD;
               -  Is correctable to a visual acuity of 20/40 or better (in each eye) with their&#xD;
                  habitual vision correction or 20/20 best-corrected.&#xD;
&#xD;
               -  Must achieve 20/30 or better (in each eye) with study lenses&#xD;
&#xD;
               -  Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D&#xD;
                  steps).&#xD;
&#xD;
               -  Has no more than 0.75 diopters of refractive astigmatism.&#xD;
&#xD;
               -  Currently wears soft contact lenses.&#xD;
&#xD;
               -  Have clear corneas and no active ocular disease.&#xD;
&#xD;
               -  Has not worn lenses for at least 12 hours before the examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A person will be excluded from the study if he/she:&#xD;
&#xD;
               -  Has never worn contact lenses before.&#xD;
&#xD;
               -  Has any systemic disease affecting ocular health.&#xD;
&#xD;
               -  Is using any systemic or topical medications that will affect ocular health.&#xD;
&#xD;
               -  Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate&#xD;
                  to severe dry eyes) that would affect the wearing of contact lenses.&#xD;
&#xD;
               -  Has persistent, clinically significant corneal or conjunctival staining using&#xD;
                  sodium fluorescein dye.&#xD;
&#xD;
               -  Has any clinically significant lid or conjunctival abnormalities, active&#xD;
                  neovascularization or any central corneal scars.&#xD;
&#xD;
               -  Is aphakic.&#xD;
&#xD;
               -  Has undergone corneal refractive surgery.&#xD;
&#xD;
               -  Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by&#xD;
                  verbal confirmation at the screening visit).&#xD;
&#xD;
               -  Have taken part in any other contact lens or care solution clinical trial or&#xD;
                  research, within one week prior to starting this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pete Kollbaum, OD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Optics Research Lab (CORL) Indiana University School of Optometry.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Ritchey, OD, PhD, FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Optical Research Lab (CORL)</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ocular Surface Institute (TOSI)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <results_first_submitted>June 19, 2020</results_first_submitted>
  <results_first_submitted_qc>June 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2020</results_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03024970/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Lens Then Control Lens</title>
          <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): contact lens stenfilcon A lens (Control): contact lens</description>
        </group>
        <group group_id="P2">
          <title>Control Lens Then Test Lens</title>
          <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens stenfilcon A lens with solution additive (test): contact lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_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="72"/>
          </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="72"/>
                  </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="72"/>
                  </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="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Ratings on Comfort</title>
        <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Comfort</title>
          <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="0.6"/>
                    <measurement group_id="O2" value="9.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Ratings on Comfort</title>
        <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Comfort</title>
          <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="1.5"/>
                    <measurement group_id="O2" value="9.0" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Ratings on Comfort</title>
        <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Comfort</title>
          <description>Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="1.7"/>
                    <measurement group_id="O2" value="8.6" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vision Satisfaction</title>
        <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Vision Satisfaction</title>
          <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vision Satisfaction</title>
        <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Vision Satisfaction</title>
          <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vision Satisfaction</title>
        <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Vision Satisfaction</title>
          <description>Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On High Illumination High Contrast</title>
        <description>Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On High Illumination High Contrast</title>
          <description>Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.06"/>
                    <measurement group_id="O2" value="-0.21" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On High Illumination High Contrast</title>
        <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On High Illumination High Contrast</title>
          <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.06"/>
                    <measurement group_id="O2" value="-0.20" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On High Illumination High Contrast</title>
        <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On High Illumination High Contrast</title>
          <description>Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.07"/>
                    <measurement group_id="O2" value="-0.20" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On Low Illumination High Contrast</title>
        <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On Low Illumination High Contrast</title>
          <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.09"/>
                    <measurement group_id="O2" value="-0.09" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On Low Illumination High Contrast</title>
        <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On Low Illumination High Contrast</title>
          <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.10"/>
                    <measurement group_id="O2" value="-0.09" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity On Low Illumination High Contrast</title>
        <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity On Low Illumination High Contrast</title>
          <description>Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.</description>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.10"/>
                    <measurement group_id="O2" value="-0.09" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Corneal Staining</title>
        <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
        <time_frame>One Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Corneal Staining</title>
          <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Garde 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Corneal Staining</title>
        <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
        <time_frame>One Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Corneal Staining</title>
          <description>Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Garde 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Conjunctival Staining</title>
        <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Staining</title>
          <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.45"/>
                    <measurement group_id="O2" value="0.39" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Conjunctival Staining</title>
        <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Staining</title>
          <description>Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.37"/>
                    <measurement group_id="O2" value="0.45" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bulbar Hyperemia</title>
        <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Bulbar Hyperemia</title>
          <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.85"/>
                    <measurement group_id="O2" value="1.28" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bulbar Hyperemia</title>
        <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Bulbar Hyperemia</title>
          <description>Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="0.81"/>
                    <measurement group_id="O2" value="1.33" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Limbal Hyperemia</title>
        <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Limbal Hyperemia</title>
          <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.64"/>
                    <measurement group_id="O2" value="0.89" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Limbal Hyperemia</title>
        <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Limbal Hyperemia</title>
          <description>Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="0.66"/>
                    <measurement group_id="O2" value="0.78" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Palpebral Hyperemia</title>
        <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Palpebral Hyperemia</title>
          <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.65"/>
                    <measurement group_id="O2" value="0.88" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Palpebral Hyperemia</title>
        <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Palpebral Hyperemia</title>
          <description>Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="0.63"/>
                    <measurement group_id="O2" value="0.93" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Fit Acceptance</title>
        <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.3"/>
                    <measurement group_id="O2" value="3.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Fit Acceptance</title>
        <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.3"/>
                    <measurement group_id="O2" value="3.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Fit Acceptance</title>
        <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.3"/>
                    <measurement group_id="O2" value="3.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Handling Satisfaction</title>
        <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Handling Satisfaction</title>
          <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Handling Satisfaction</title>
        <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Handling Satisfaction</title>
          <description>Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strongly disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disagree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strongly Agree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Wettability</title>
        <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Wettability</title>
          <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.52" spread="0.36"/>
                    <measurement group_id="O2" value="3.52" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Wettability</title>
        <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Wettability</title>
          <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="0.46"/>
                    <measurement group_id="O2" value="3.33" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Wettability</title>
        <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Wettability</title>
          <description>Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread="0.43"/>
                    <measurement group_id="O2" value="3.38" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Deposits</title>
        <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Deposits</title>
          <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.15"/>
                    <measurement group_id="O2" value="0.02" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Deposits</title>
        <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Deposits</title>
          <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.20"/>
                    <measurement group_id="O2" value="0.04" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Surface - Deposits</title>
        <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface - Deposits</title>
          <description>Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.27"/>
                    <measurement group_id="O2" value="0.02" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ratings on Dryness</title>
        <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Dryness</title>
          <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="1.3"/>
                    <measurement group_id="O2" value="9.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ratings on Dryness</title>
        <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Dryness</title>
          <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="1.8"/>
                    <measurement group_id="O2" value="8.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ratings on Dryness</title>
        <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A Lens With Solution Additive (Test)</title>
            <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
          </group>
          <group group_id="O2">
            <title>Stenfilcon A Lens (Control)</title>
            <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings on Dryness</title>
          <description>Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="2.1"/>
                    <measurement group_id="O2" value="8.1" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 1 month on each pair of lenses.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Stenfilcon A Lens With Solution Additive (Test)</title>
          <description>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.&#xD;
stenfilcon A lens with solution additive (test): silicone hydrogel lens</description>
        </group>
        <group group_id="E2">
          <title>Stenfilcon A Lens (Control)</title>
          <description>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.&#xD;
stenfilcon A lens (control): contact lens</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="72"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal Staining</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Subconjuctival Hyperemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Epithelial defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </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>Myhanh Nguyen, OD, FAAO</name_or_title>
      <organization>CooperVision, Inc.</organization>
      <phone>925-730-6716</phone>
      <email>mnguyen@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/NCT03024970
org study id: CV-16-60
nct id: NCT03024970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to investigate the overall clinical performance of the test
      daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A
      lens (control).
This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month
      cross-over, dispensing study comparing the test lens against the stenfilcon A control lens
      with a study duration of approximately two months.

      Each subject will be randomized to wear either the test or control as a matched pair first
      and subjects will be randomized based on the order in which the subject is enrolled and
      qualified into the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Subjective Ratings on Comfort
time frame: Baseline
description: Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
measure: Subjective Ratings on Comfort
time frame: 1 Week
description: Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
measure: Subjective Ratings on Comfort
time frame: 1 Month
description: Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
measure: Vision Satisfaction
time frame: Baseline
description: Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
measure: Vision Satisfaction
time frame: 1 week
description: Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
measure: Vision Satisfaction
time frame: 1 Month
description: Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
measure: Visual Acuity On High Illumination High Contrast
time frame: Baseline
description: Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Visual Acuity On High Illumination High Contrast
time frame: 1 Week
description: Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Visual Acuity On High Illumination High Contrast
time frame: 1 Month
description: Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Visual Acuity On Low Illumination High Contrast
time frame: Baseline
description: Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Visual Acuity On Low Illumination High Contrast
time frame: 1 Week
description: Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Visual Acuity On Low Illumination High Contrast
time frame: 1 Month
description: Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
measure: Overall Corneal Staining
time frame: One Week
description: Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
measure: Overall Corneal Staining
time frame: One Month
description: Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
measure: Conjunctival Staining
time frame: 1 Week
description: Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
measure: Conjunctival Staining
time frame: 1 Month
description: Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
measure: Bulbar Hyperemia
time frame: 1 Week
description: Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Bulbar Hyperemia
time frame: 1 Month
description: Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Limbal Hyperemia
time frame: 1 Week
description: Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Limbal Hyperemia
time frame: 1 Month
description: Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Palpebral Hyperemia
time frame: 1 Week
description: Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Palpebral Hyperemia
time frame: 1 Month
description: Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
measure: Lens Fit Acceptance
time frame: Baseline
description: Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
measure: Lens Fit Acceptance
time frame: 1 week
description: Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
measure: Lens Fit Acceptance
time frame: 1 Month
description: Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
measure: Handling Satisfaction
time frame: 1 week
description: Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
measure: Handling Satisfaction
time frame: 1 Month
description: Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
measure: Lens Surface - Wettability
time frame: Baseline
description: Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
measure: Lens Surface - Wettability
time frame: 1 Week
description: Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
measure: Lens Surface - Wettability
time frame: 1 Month
description: Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
measure: Lens Surface - Deposits
time frame: Baseline
description: Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
measure: Lens Surface - Deposits
time frame: 1 week
description: Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
measure: Lens Surface - Deposits
time frame: 1 Month
description: Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
measure: Subjective Ratings on Dryness
time frame: Baseline
description: Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
measure: Subjective Ratings on Dryness
time frame: 1 week
description: Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
measure: Subjective Ratings on Dryness
time frame: 1 Month
description: Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
arm group label: stenfilcon A lens with solution additive (test)
arm group type: Experimental
description: Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
arm group label: stenfilcon A lens (control)
arm group type: Active Comparator
description: Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
intervention type: Device
intervention name: stenfilcon A lens with solution additive (test)
description: silicone hydrogel lens
arm group label: stenfilcon A lens (control)
arm group label: stenfilcon A lens with solution additive (test)
intervention type: Device
intervention name: stenfilcon A lens (control)
description: contact lens
arm group label: stenfilcon A lens (control)
arm group label: stenfilcon A lens with solution additive (test)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pete Kollbaum, OD, PhD
role: Principal Investigator
affiliation: Clinical Optics Research Lab (CORL) Indiana University School of Optometry.
last name: Eric Ritchey, OD, PhD, FAAO
role: Principal Investigator
affiliation: University of Houston
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 