<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/NCT03782571</url>
  </required_header>
  <id_info>
    <org_study_id>CR-6291</org_study_id>
    <nct_id>NCT03782571</nct_id>
  </id_info>
  <brief_title>Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film</brief_title>
  <official_title>Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Vision Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Vision Care, 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>
      This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments&#xD;
      x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle&#xD;
      correction having not worn contact lenses on the day of the visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2018</start_date>
  <completion_date type="Actual">March 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microsphere Clearance Rate</measure>
    <time_frame>Post microsphere application over a 30 minute period</time_frame>
    <description>The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microsphere Uptake Rate</measure>
    <time_frame>Post microsphere application over a 10 minute period</time_frame>
    <description>The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lens Movement</measure>
    <time_frame>Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)</time_frame>
    <description>Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Curvature</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Curvature</measure>
    <time_frame>Baseline</time_frame>
    <description>Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blink Rate</measure>
    <time_frame>Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.</time_frame>
    <description>Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>Test1/Test2/Control/Test3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test2/Test3/Test1/Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test3/Control/Test2/Test1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Test1/Test3/Test2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon a Test 1</intervention_name>
    <description>1-DAY ACUVUE® MOIST</description>
    <arm_group_label>Control/Test1/Test3/Test2</arm_group_label>
    <arm_group_label>Test1/Test2/Control/Test3</arm_group_label>
    <arm_group_label>Test2/Test3/Test1/Control</arm_group_label>
    <arm_group_label>Test3/Control/Test2/Test1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon A Test 2</intervention_name>
    <description>1-DAY ACUVUE® MOIST for ASTIGMATISM</description>
    <arm_group_label>Control/Test1/Test3/Test2</arm_group_label>
    <arm_group_label>Test1/Test2/Control/Test3</arm_group_label>
    <arm_group_label>Test2/Test3/Test1/Control</arm_group_label>
    <arm_group_label>Test3/Control/Test2/Test1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon A Test 3</intervention_name>
    <description>1-DAY ACUVUE® MOIST MULTIFOCAL</description>
    <arm_group_label>Control/Test1/Test3/Test2</arm_group_label>
    <arm_group_label>Test1/Test2/Control/Test3</arm_group_label>
    <arm_group_label>Test2/Test3/Test1/Control</arm_group_label>
    <arm_group_label>Test3/Control/Test2/Test1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Bare Eye</description>
    <arm_group_label>Control/Test1/Test3/Test2</arm_group_label>
    <arm_group_label>Test1/Test2/Control/Test3</arm_group_label>
    <arm_group_label>Test2/Test3/Test1/Control</arm_group_label>
    <arm_group_label>Test3/Control/Test2/Test1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must satisfy all of the following criteria to be enrolled in the&#xD;
             study:&#xD;
&#xD;
               1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and&#xD;
                  receive a fully executed copy of the form.&#xD;
&#xD;
               2. The subject must appear able and willing to adhere to the instructions set forth&#xD;
                  in this clinical protocol.&#xD;
&#xD;
               3. The subject must be between 18 and 40 (inclusive) years of age at the time of&#xD;
                  screening.&#xD;
&#xD;
               4. The subject must own a wearable pair of spectacles and be willing to wear them to&#xD;
                  each study visit.&#xD;
&#xD;
               5. The subject must be an adapted soft contact lens wearer in both eyes, having&#xD;
                  successfully worn contact lenses in the last six months by self-report.&#xD;
&#xD;
               6. The subject must agree not to participate in other clinical research for the&#xD;
                  duration of this study.&#xD;
&#xD;
               7. The subject's refractive cylinder must be &lt;-1.25DC in each eye.&#xD;
&#xD;
               8. The subject must have best corrected visual acuity of 0.20 logMAR or better in&#xD;
                  each eye.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects who meet any of the following criteria will be excluded from&#xD;
             participating in the study:&#xD;
&#xD;
               1. Currently pregnant or breast feeding (self-reported).&#xD;
&#xD;
               2. Any systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g.,&#xD;
                  hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV),&#xD;
                  autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by&#xD;
                  self-report, which are known to interfere with contact lens wear and/or&#xD;
                  participation in the study (at the Investigator's discretion).&#xD;
&#xD;
               3. Use of topical medication such as eye drops or ointment within 24 hours prior to&#xD;
                  the study visit.&#xD;
&#xD;
               4. Any history of anaphylaxis or severe allergy.&#xD;
&#xD;
               5. Any previous, or planned (during the course of the study) ocular surgery (e.g.,&#xD;
                  radial keratotomy, PRK, LASIK, etc.)&#xD;
&#xD;
               6. Participation in any contact lens or lens care product clinical trial within 14&#xD;
                  days prior to study enrollment&#xD;
&#xD;
               7. Employee or immediate family member of an employee of clinical site (e.g.,&#xD;
                  Investigator, Coordinator, Technician)&#xD;
&#xD;
               8. They have any slit lamp findings of grade 3 or higher (e.g. corneal edema,&#xD;
                  corneal neovascularization, tarsal abnormalities, conjunctival injection) or&#xD;
                  findings of &lt; Grade 3 which in the investigator's opinion would contraindicate&#xD;
                  contact lens wear.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>March 24, 2020</results_first_submitted>
  <results_first_submitted_qc>April 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>April 30, 2020</last_update_submitted>
  <last_update_submitted_qc>April 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>September 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03782571/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 34 subjects were enrolled into the study. Of the enrolled 9 subjects did not meet the eligibility criteria. 22 subjects completed the study and 3 subjects were discontinued from the study.</recruitment_details>
      <pre_assignment_details>Subjects were randomized to 1 of 4 unique lens sequences.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test 1\Control\Test 2\Test 3</title>
          <description>Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, and Test 3 in period 4.</description>
        </group>
        <group group_id="P2">
          <title>Test 2\Test 1\Test 3\Control</title>
          <description>Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, and Control in period 4.</description>
        </group>
        <group group_id="P3">
          <title>Control\Test 3\Test 1\Test 2</title>
          <description>Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 3 in period 2, Test 1 in period 3, and Test 2 in period 4.</description>
        </group>
        <group group_id="P4">
          <title>Test 3\Test 2\Control\Test 1</title>
          <description>Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Control in period 3, and 1 Test 1 in period 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject Unable to Attend V5</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects dispensed a study lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Total</title>
          <description>All subjects dispensed a study lens.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.6" spread="7.44"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Microsphere Clearance Rate</title>
        <description>The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.</description>
        <time_frame>Post microsphere application over a 30 minute period</time_frame>
        <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Test 1</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O2">
            <title>Test 2</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O3">
            <title>Test 3</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O4">
            <title>Control (Bare Eye)</title>
            <description>Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Microsphere Clearance Rate</title>
          <description>The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.</description>
          <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol</population>
          <units>percent clearance</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="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9" spread="1.16"/>
                    <measurement group_id="O2" value="98.1" spread="2.66"/>
                    <measurement group_id="O3" value="99.4" spread="3.67"/>
                    <measurement group_id="O4" value="96.6" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.97</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.0</ci_lower_limit>
            <ci_upper_limit>7.4</ci_upper_limit>
            <estimate_desc>Test 1 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.01</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.0</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
            <estimate_desc>Test 2 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.78</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>19.1</ci_upper_limit>
            <estimate_desc>Test 3 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.12</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>15.5</ci_upper_limit>
            <estimate_desc>Test 3 - Test 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.88</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>8.9</ci_upper_limit>
            <estimate_desc>Test 3 - Test 2</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere clearance rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.54</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Test 2 - Test 1</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Microsphere Uptake Rate</title>
        <description>The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.</description>
        <time_frame>Post microsphere application over a 10 minute period</time_frame>
        <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Test 1</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O2">
            <title>Test 2</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O3">
            <title>Test 3</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O4">
            <title>Control (Bare Eye)</title>
            <description>Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Microsphere Uptake Rate</title>
          <description>The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.</description>
          <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol</population>
          <units>percent uptake</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="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="4.09"/>
                    <measurement group_id="O2" value="6.8" spread="5.31"/>
                    <measurement group_id="O3" value="2.9" spread="3.35"/>
                    <measurement group_id="O4" value="1.5" spread="7.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.24</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>17.8</ci_upper_limit>
            <estimate_desc>Test 1 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.95</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.8</ci_lower_limit>
            <ci_upper_limit>20.9</ci_upper_limit>
            <estimate_desc>Test 2 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.22</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.1</ci_lower_limit>
            <ci_upper_limit>20.9</ci_upper_limit>
            <estimate_desc>Test 3 - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.13</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.4</ci_lower_limit>
            <ci_upper_limit>9.4</ci_upper_limit>
            <estimate_desc>Test 3 - Test 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.10</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.6</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
            <estimate_desc>Test 3 - Test 2</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Testing equivalence with respect to microsphere uptake rate.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.18</dispersion_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.9</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Test 2 - Test 1</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lens Movement</title>
        <description>Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.</description>
        <time_frame>Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)</time_frame>
        <population>All subjects dispensed a study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Test 1</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O2">
            <title>Test 2</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O3">
            <title>Test 3</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Movement</title>
          <description>Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.</description>
          <population>All subjects dispensed a study lens.</population>
          <units>eyes</units>
          <param>Count of Units</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Primary Position</title>
              <category_list>
                <category>
                  <title>Insufficient(-2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal(-1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimal(0)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate(+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Excessive(+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Push Up</title>
              <category_list>
                <category>
                  <title>Insufficient(-2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal(-1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimal(0)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate(+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Excessive(+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Up-gaze</title>
              <category_list>
                <category>
                  <title>Insufficient(-2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal(-1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimal(0)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate(+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Excessive(+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corneal Curvature</title>
        <description>Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.</description>
        <time_frame>Baseline</time_frame>
        <population>All subjects dispensed a study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>All subjects dispensed a study lens.</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Curvature</title>
          <description>Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.</description>
          <population>All subjects dispensed a study lens.</population>
          <units>Degree</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="25"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sclera Angle-Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.14" spread="2.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sclera Angle-Nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.64" spread="3.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corneal Curvature</title>
        <description>Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.</description>
        <time_frame>Baseline</time_frame>
        <population>All subjects dispensed a study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>All subjects dispensed a study lens.</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Curvature</title>
          <description>Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.</description>
          <population>All subjects dispensed a study lens.</population>
          <units>Millimeter</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="25"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.700" spread="0.1854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blink Rate</title>
        <description>Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.</description>
        <time_frame>Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.</time_frame>
        <population>All subjects dispensed a study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Test 1</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O2">
            <title>Test 2</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O3">
            <title>Test 3</title>
            <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
          </group>
          <group group_id="O4">
            <title>Control (Bare Eye)</title>
            <description>Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study.</description>
          </group>
          <group group_id="O5">
            <title>Total</title>
            <description>All subjects dispensed a study lens.</description>
          </group>
        </group_list>
        <measure>
          <title>Blink Rate</title>
          <description>Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.</description>
          <population>All subjects dispensed a study lens.</population>
          <units>blinks per minute</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="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="25"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="28.2" spread="16.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Lens Insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="11.63"/>
                    <measurement group_id="O2" value="26.1" spread="15.88"/>
                    <measurement group_id="O3" value="25.0" spread="13.02"/>
                    <measurement group_id="O4" value="19.8" spread="13.08"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study. Approximately 13 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test 1</title>
          <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
        </group>
        <group group_id="E2">
          <title>Test 2</title>
          <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
        </group>
        <group group_id="E3">
          <title>Test 3</title>
          <description>Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study</description>
        </group>
        <group group_id="E4">
          <title>Control (Bare Eye)</title>
          <description>Subjects were under bare eye condition in either the first, second, third, or fourth period of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Unconfirmed Corneal Endothelium Keratic Precipitate</sub_title>
                <description>Unconfirmed Corneal Endothelium Keratic Precipitate was reported in the right eye. The adverse event was deemed unrelated to the study by the investigator and the subject was discontinued.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas R. Karkkainen, OD, MS, FAAO</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care, Inc.</organization>
      <phone>904 443-3402 ext 2126</phone>
      <email>TKarkkai@its.jnj.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/NCT03782571
org study id: CR-6291
nct id: NCT03782571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments
      x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle
      correction having not worn contact lenses on the day of the visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Microsphere Clearance Rate
time frame: Post microsphere application over a 30 minute period
description: The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance.
measure: Microsphere Uptake Rate
time frame: Post microsphere application over a 10 minute period
description: The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake.
measure: Lens Movement
time frame: Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)
description: Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported.
measure: Corneal Curvature
time frame: Baseline
description: Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal.
measure: Corneal Curvature
time frame: Baseline
description: Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured.
measure: Blink Rate
time frame: Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.
description: Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported.
arm group label: Test1/Test2/Control/Test3
arm group type: Experimental
description: Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
arm group label: Test2/Test3/Test1/Control
arm group type: Experimental
description: Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
arm group label: Test3/Control/Test2/Test1
arm group type: Experimental
description: Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
arm group label: Control/Test1/Test3/Test2
arm group type: Experimental
description: Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
intervention type: Device
intervention name: etafilcon a Test 1
description: 1-DAY ACUVUE® MOIST
arm group label: Control/Test1/Test3/Test2
arm group label: Test1/Test2/Control/Test3
arm group label: Test2/Test3/Test1/Control
arm group label: Test3/Control/Test2/Test1
intervention type: Device
intervention name: etafilcon A Test 2
description: 1-DAY ACUVUE® MOIST for ASTIGMATISM
arm group label: Control/Test1/Test3/Test2
arm group label: Test1/Test2/Control/Test3
arm group label: Test2/Test3/Test1/Control
arm group label: Test3/Control/Test2/Test1
intervention type: Device
intervention name: etafilcon A Test 3
description: 1-DAY ACUVUE® MOIST MULTIFOCAL
arm group label: Control/Test1/Test3/Test2
arm group label: Test1/Test2/Control/Test3
arm group label: Test2/Test3/Test1/Control
arm group label: Test3/Control/Test2/Test1
intervention type: Other
intervention name: Control
description: Bare Eye
arm group label: Control/Test1/Test3/Test2
arm group label: Test1/Test2/Control/Test3
arm group label: Test2/Test3/Test1/Control
arm group label: Test3/Control/Test2/Test1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 