<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/NCT04492397</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-114</org_study_id>
    <nct_id>NCT04492397</nct_id>
  </id_info>
  <brief_title>Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)</brief_title>
  <official_title>Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate and compare the performance of study test lens to&#xD;
      study control lens, when worn on a daily disposable modality over a period of approximately&#xD;
      one week each&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, double masked (investigator and participant), bilateral,&#xD;
      randomized,one week cross-over dispensing study, which evaluates the study test lens and&#xD;
      control lens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Overall Lens Fit Acceptance</measure>
    <time_frame>1 week</time_frame>
    <description>Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lens Centration</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lens Centration</measure>
    <time_frame>1 week</time_frame>
    <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-blink Movement</measure>
    <time_frame>Baseline</time_frame>
    <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-blink Movement</measure>
    <time_frame>1 week</time_frame>
    <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Push-up Tightness</measure>
    <time_frame>Baseline</time_frame>
    <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Push-up Tightness</measure>
    <time_frame>1 week</time_frame>
    <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Test Contact lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Contact Lens</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test Contact Lens</intervention_name>
    <description>Subjects will be randomized to wear test lenses.</description>
    <arm_group_label>Control Contact Lens</arm_group_label>
    <arm_group_label>Test Contact lens</arm_group_label>
    <other_name>stenfilcon A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Contact Lens</intervention_name>
    <description>Subjects will be randomized to wear control lenses.</description>
    <arm_group_label>Control Contact Lens</arm_group_label>
    <arm_group_label>Test Contact lens</arm_group_label>
    <other_name>verofilcon A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is at least 17 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          2. Has read and signed an information consent letter;&#xD;
&#xD;
          3. Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months;&#xD;
&#xD;
          5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study&#xD;
             lenses;&#xD;
&#xD;
          6. Has an astigmatism of ≤ 1.00 D in subjective refraction;&#xD;
&#xD;
          7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;&#xD;
&#xD;
          8. Demonstrates an acceptable fit with the study lenses;&#xD;
&#xD;
          9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5&#xD;
             days a week, and is willing to wear contact lenses for at least 12 hours a day in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          2. Has any known active* ocular disease and/or infection;&#xD;
&#xD;
          3. Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          4. Is using any systemic or topical medications that in the opinion of the investigator&#xD;
             may affect a study outcome variable;&#xD;
&#xD;
          5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;&#xD;
&#xD;
          6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the&#xD;
             associated hormonal changes cause changes in the tear layer which impact contact lens&#xD;
             comfort. Verbal confirmation at the screening visit is sufficient;&#xD;
&#xD;
          7. Is aphakic;&#xD;
&#xD;
          8. Has undergone refractive error surgery;&#xD;
&#xD;
          9. Is an employee of the Centre for Ocular Research &amp; Education;&#xD;
&#xD;
         10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113)&#xD;
             Study;&#xD;
&#xD;
         11. Has participated in any clinical trials within a week prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD FCOptom</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Waterloo</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <results_first_submitted>May 27, 2021</results_first_submitted>
  <results_first_submitted_qc>May 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2021</results_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</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>
  <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>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT04492397/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Forty-one subjects were screened and 35 subjects started and completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Contact Lens the Control Contact Lens</title>
          <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Test Contact Lens: Subjects will be randomized to wear test lenses.&#xD;
Control Contact Lens: Subjects will be randomized to wear control lenses.</description>
        </group>
        <group group_id="P2">
          <title>Control Contact Lens Then Test Contact Lens</title>
          <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Test Contact Lens: Subjects will be randomized to wear test lenses.&#xD;
Control Contact Lens: Subjects will be randomized to wear control lenses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Forty-one subjects were screened and demographic data includes all screened subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Subjects will be randomized to wear control lenses and test lenses for one week.&#xD;
Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
          </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="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.8" spread="9.3"/>
                  </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="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Lens Fit Acceptance</title>
        <description>Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Lens Fit Acceptance</title>
          <description>Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" spread="0.33"/>
                    <measurement group_id="O2" value="3.73" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Centration</title>
        <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Centration</title>
          <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.50"/>
                    <measurement group_id="O2" value="0.29" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Centration</title>
        <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Centration</title>
          <description>Lens Centration was measured on a scale (0-3) (0 = &quot;Optimally centered&quot;, 1 = &quot;Slightly decentered&quot;, 2 = Moderate decentration but not encroaching limbus, 3 = &quot;Excessive &amp; occasionally encroaching limbus&quot;)</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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.38"/>
                    <measurement group_id="O2" value="0.20" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-blink Movement</title>
        <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement</title>
          <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </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="0.23" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-blink Movement</title>
        <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Post-blink Movement</title>
          <description>Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.05"/>
                    <measurement group_id="O2" value="0.23" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Push-up Tightness</title>
        <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% 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 Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Push-up Tightness</title>
          <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% 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>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" spread="5"/>
                    <measurement group_id="O2" value="49" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Push-up Tightness</title>
        <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.&#xD;
Contact lenses: Test Contact Lens</description>
          </group>
          <group group_id="O2">
            <title>Control Contact Lens</title>
            <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.&#xD;
Contact lenses: Control Contact Lens</description>
          </group>
        </group_list>
        <measure>
          <title>Push-up Tightness</title>
          <description>Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="4"/>
                    <measurement group_id="O2" value="48" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to 1 week for a total of 2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Contact Lens</title>
          <description>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.</description>
        </group>
        <group group_id="E2">
          <title>Control Contact Lens</title>
          <description>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.</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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jose A. Vega, O.D., MSc, FAAO</name_or_title>
      <organization>Coopervision</organization>
      <phone>9256213761</phone>
      <email>JVega2@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/NCT04492397
org study id: EX-MKTG-114
nct id: NCT04492397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the study is to evaluate and compare the performance of study test lens to
      study control lens, when worn on a daily disposable modality over a period of approximately
      one week each
The study is a prospective, double masked (investigator and participant), bilateral,
      randomized,one week cross-over dispensing study, which evaluates the study test lens and
      control lens.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Lens Fit Acceptance
time frame: 1 week
description: Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
measure: Lens Centration
time frame: Baseline
description: Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
measure: Lens Centration
time frame: 1 week
description: Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
measure: Post-blink Movement
time frame: Baseline
description: Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
measure: Post-blink Movement
time frame: 1 week
description: Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
measure: Push-up Tightness
time frame: Baseline
description: Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
measure: Push-up Tightness
time frame: 1 week
description: Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
arm group label: Test Contact lens
arm group type: Experimental
description: Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
arm group label: Control Contact Lens
arm group type: Active Comparator
description: Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
intervention type: Device
intervention name: Test Contact Lens
description: Subjects will be randomized to wear test lenses.
arm group label: Control Contact Lens
arm group label: Test Contact lens
other name: stenfilcon A
intervention type: Device
intervention name: Control Contact Lens
description: Subjects will be randomized to wear control lenses.
arm group label: Control Contact Lens
arm group label: Test Contact lens
other name: verofilcon A
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lyndon Jones, PhD FCOptom
role: Principal Investigator
affiliation: University of Waterloo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Myopia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 