<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/NCT03235089</url>
  </required_header>
  <id_info>
    <org_study_id>CV-17-46</org_study_id>
    <nct_id>NCT03235089</nct_id>
  </id_info>
  <brief_title>A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses</brief_title>
  <official_title>A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate the clinical performance of a new contact lens&#xD;
      design when worn over a period of 6 hours compared to nelfilcon A (control).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to validate the clinical performance of a new contact lens&#xD;
      design when worn over a period of 6 hours compared to nelfilcon A (control). The primary&#xD;
      outcomes of interest are lens fit and lens fit preference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">August 3, 2017</completion_date>
  <primary_completion_date type="Actual">August 3, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Horizontal Lens Centration Assessed in Primary Gaze</measure>
    <time_frame>Baseline</time_frame>
    <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Horizontal Lens Centration Assessed in Primary Gaze</measure>
    <time_frame>6-hour</time_frame>
    <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical Lens Centration Assessed in Primary Gaze</measure>
    <time_frame>Baseline</time_frame>
    <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical Lens Centration Assessed in Primary Gaze</measure>
    <time_frame>6-hours</time_frame>
    <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessed by Push-up Test</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Tightness Assessed by Push-up Test</measure>
    <time_frame>6-hours</time_frame>
    <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>Baseline</time_frame>
    <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>6 hours</time_frame>
    <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>Baseline</time_frame>
    <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>6 hours</time_frame>
    <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Lens Fit Acceptance</measure>
    <time_frame>6 hours</time_frame>
    <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Up Gaze Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>Baseline</time_frame>
    <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Up Gaze Lag Assessed Observing Lens Movement in Graticule</measure>
    <time_frame>6 hours</time_frame>
    <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</measure>
    <time_frame>6 hours</time_frame>
    <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Test lens</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test Lens</intervention_name>
    <description>Daily disposable contact lens</description>
    <arm_group_label>Test lens</arm_group_label>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Lens</intervention_name>
    <description>Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
    <arm_group_label>Test lens</arm_group_label>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is at least 18 years of age and has full legal capacity to volunteer&#xD;
&#xD;
          -  Has read, fully understood and signed the information consent letter&#xD;
&#xD;
          -  Currently wears or has previously worn soft contact lenses&#xD;
&#xD;
          -  Has spectacle cylinder ≤1.00D in both eyes.&#xD;
&#xD;
          -  Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.&#xD;
&#xD;
          -  Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent&#xD;
             of 20/25 in each eye.&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Is willing and able to follow product usage instructions and maintain the visit&#xD;
             schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has never worn contact lenses before&#xD;
&#xD;
          -  Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable&#xD;
&#xD;
          -  Is using any systemic or topical medications that in the opinion of the investigator&#xD;
             may affect a study outcome variable&#xD;
&#xD;
          -  Has any known active ocular disease and/or infection&#xD;
&#xD;
          -  Has a monovision correction&#xD;
&#xD;
          -  Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to&#xD;
             severe dry eyes) that would affect the wearing of contact lenses&#xD;
&#xD;
          -  Is aphakic&#xD;
&#xD;
          -  Has undergone corneal refractive surgery&#xD;
&#xD;
          -  Is pregnant or lactating, determined by self-report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>September 1, 2020</results_first_submitted>
  <results_first_submitted_qc>September 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2020</results_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 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>July 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03235089/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Lens</title>
          <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
        </group>
        <group group_id="P2">
          <title>Nelfilcon A Lens (Control)</title>
          <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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>Subjects were randomized to wear test lens in one eye and control lens in other eye for 6 hours.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </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="28"/>
                  </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="28"/>
                  </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="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Horizontal Lens Centration Assessed in Primary Gaze</title>
        <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Horizontal Lens Centration Assessed in Primary Gaze</title>
          <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.20"/>
                    <measurement group_id="O2" value="-0.04" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Horizontal Lens Centration Assessed in Primary Gaze</title>
        <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
        <time_frame>6-hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Horizontal Lens Centration Assessed in Primary Gaze</title>
          <description>Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.20"/>
                    <measurement group_id="O2" value="-0.06" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vertical Lens Centration Assessed in Primary Gaze</title>
        <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Vertical Lens Centration Assessed in Primary Gaze</title>
          <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.25"/>
                    <measurement group_id="O2" value="0.06" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vertical Lens Centration Assessed in Primary Gaze</title>
        <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
        <time_frame>6-hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Vertical Lens Centration Assessed in Primary Gaze</title>
          <description>Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.22"/>
                    <measurement group_id="O2" value="-0.03" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessed by Push-up Test</title>
        <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessed by Push-up Test</title>
          <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="7"/>
                    <measurement group_id="O2" value="41" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Tightness Assessed by Push-up Test</title>
        <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</description>
        <time_frame>6-hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Tightness Assessed by Push-up Test</title>
          <description>Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" spread="8"/>
                    <measurement group_id="O2" value="49" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.06"/>
                    <measurement group_id="O2" value="0.13" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Gaze Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.08"/>
                    <measurement group_id="O2" value="0.12" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.3"/>
                    <measurement group_id="O2" value="2.7" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Horizontal Lens Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.3"/>
                    <measurement group_id="O2" value="2.7" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance</title>
        <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 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>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens ( Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance</title>
          <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.6"/>
                    <measurement group_id="O2" value="3.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance</title>
        <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance</title>
          <description>Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.5"/>
                    <measurement group_id="O2" value="3.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Up Gaze Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Up Gaze Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.18"/>
                    <measurement group_id="O2" value="0.38" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Up Gaze Lag Assessed Observing Lens Movement in Graticule</title>
        <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Up Gaze Lag Assessed Observing Lens Movement in Graticule</title>
          <description>Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.11"/>
                    <measurement group_id="O2" value="0.35" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</title>
        <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</title>
          <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="0.14"/>
                    <measurement group_id="O2" value="0.31" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</title>
        <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Lens</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink</title>
          <description>Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink</description>
          <units>millimeters</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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.17"/>
                    <measurement group_id="O2" value="0.29" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to 6 hours on each type of study lenses</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Lens</title>
          <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Test Lens: Daily disposable contact lens</description>
        </group>
        <group group_id="E2">
          <title>Nelfilcon A Lens ( Control)</title>
          <description>Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule.&#xD;
Control Lens: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Lee Hall, BSc, PhD, MCOptom, FBCLA</name_or_title>
      <organization>CooperVision, Inc</organization>
      <phone>925 251 6684</phone>
      <email>lhall@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/NCT03235089
org study id: CV-17-46
nct id: NCT03235089
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period of 6 hours compared to nelfilcon A (control).
The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period of 6 hours compared to nelfilcon A (control). The primary
      outcomes of interest are lens fit and lens fit preference.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
measure: Horizontal Lens Centration Assessed in Primary Gaze
time frame: Baseline
description: Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
measure: Horizontal Lens Centration Assessed in Primary Gaze
time frame: 6-hour
description: Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
measure: Vertical Lens Centration Assessed in Primary Gaze
time frame: Baseline
description: Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
measure: Vertical Lens Centration Assessed in Primary Gaze
time frame: 6-hours
description: Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
measure: Lens Tightness Assessed by Push-up Test
time frame: Baseline
description: Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
measure: Lens Tightness Assessed by Push-up Test
time frame: 6-hours
description: Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
measure: Primary Gaze Lag Assessed Observing Lens Movement in Graticule
time frame: Baseline
description: Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
measure: Primary Gaze Lag Assessed Observing Lens Movement in Graticule
time frame: 6 hours
description: Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
measure: Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
time frame: Baseline
description: Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
measure: Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
time frame: 6 hours
description: Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
measure: Overall Lens Fit Acceptance
time frame: Baseline
description: Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
measure: Overall Lens Fit Acceptance
time frame: 6 hours
description: Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
measure: Up Gaze Lag Assessed Observing Lens Movement in Graticule
time frame: Baseline
description: Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
measure: Up Gaze Lag Assessed Observing Lens Movement in Graticule
time frame: 6 hours
description: Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
measure: Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
time frame: Baseline
description: Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
measure: Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
time frame: 6 hours
description: Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
arm group label: Test lens
arm group type: Active Comparator
description: Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
arm group label: nelfilcon A lens (control)
arm group type: Active Comparator
description: Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
intervention type: Device
intervention name: Test Lens
description: Daily disposable contact lens
arm group label: Test lens
arm group label: nelfilcon A lens (control)
intervention type: Device
intervention name: Control Lens
description: Focus Dailies All Day Comfort contact lens (nelfilcon A)
arm group label: Test lens
arm group label: nelfilcon A lens (control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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: 