<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/NCT01669629</url>
  </required_header>
  <id_info>
    <org_study_id>CR-005199</org_study_id>
    <nct_id>NCT01669629</nct_id>
  </id_info>
  <brief_title>Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear</brief_title>
  <official_title>Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a&#xD;
      primary hypothesis of comparing the handling of each lens. Additional secondary markers are&#xD;
      measured looking at subjective comfort and vision of the lenses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject Reported Ease of Removal</measure>
    <time_frame>6-10 Days</time_frame>
    <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Reported Overall Comfort</measure>
    <time_frame>6-10 Days</time_frame>
    <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Reported Overall Vision</measure>
    <time_frame>6-10 Days</time_frame>
    <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binocular Snellen Visual Acuity</measure>
    <time_frame>6-10 Days</time_frame>
    <description>Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Corneal Staining</measure>
    <time_frame>6-10 Days</time_frame>
    <description>Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.&#xD;
Grade 1 or higher is reported as a percentage of total eyes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Delefilcon A/ Etafilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etafilcon A / Delefilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>delefilcon A</intervention_name>
    <description>Daily wear soft contact lens for bilateral distance vision correction use.</description>
    <arm_group_label>Delefilcon A/ Etafilcon A</arm_group_label>
    <arm_group_label>Etafilcon A / Delefilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon A</intervention_name>
    <description>Daily wear soft contact lens for bilateral distance vision correction use.</description>
    <arm_group_label>Delefilcon A/ Etafilcon A</arm_group_label>
    <arm_group_label>Etafilcon A / Delefilcon A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.&#xD;
&#xD;
          -  The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and&#xD;
             receive a fully executed copy of the form. This should be recorded on the Case Report&#xD;
             Form (CRF).&#xD;
&#xD;
          -  The subject must be willing to wear the study lenses for at least 8 hours per day, 7&#xD;
             days per week.&#xD;
&#xD;
          -  The subject must be a current successful soft contact lens wearer in both eyes&#xD;
&#xD;
          -  The subject must appear able and willing to adhere to the instructions set forth in&#xD;
             this clinical protocol.&#xD;
&#xD;
          -  The subject's subjective refraction must result in a vertex corrected spherical&#xD;
             contact lens prescription in the range of -1.00D to -6.00D in each eye.&#xD;
&#xD;
          -  The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.&#xD;
&#xD;
          -  The subject must have best corrected visual acuity of 20/30 (6/9) or better in each&#xD;
             eye.&#xD;
&#xD;
          -  The subject must require a visual correction in both eyes (no monofit or monovision&#xD;
             allowed).&#xD;
&#xD;
          -  The subject must have normal eyes with no evidence of abnormality or disease. For the&#xD;
             purposes of this study a normal eye is defined as one having:&#xD;
&#xD;
               1. No amblyopia.&#xD;
&#xD;
               2. No evidence of lid abnormality or infection (including blepharitis/meibomitis).&#xD;
&#xD;
               3. No conjunctival abnormality or infection.&#xD;
&#xD;
               4. No clinically significant slit lamp findings (i.e. stromal edema,&#xD;
                  vascularization, infiltrates or abnormal opacities).&#xD;
&#xD;
               5. No other active ocular disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any ocular or systemic allergies or diseases that may interfere with contact lens&#xD;
             wear.&#xD;
&#xD;
          -  Any systemic disease, autoimmune disease, or use of medication, which may interfere&#xD;
             with contact lens wear.&#xD;
&#xD;
          -  Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal&#xD;
             staining, or any other abnormalities of the cornea which would contraindicate contact&#xD;
             lens wear.&#xD;
&#xD;
          -  Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which&#xD;
             might interfere with contact lens wear.&#xD;
&#xD;
          -  Any ocular infection.&#xD;
&#xD;
          -  Any corneal distortion resulting from previous hard or rigid gas permeable contact&#xD;
             lens wear.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  No extended wear in the last 3 months.&#xD;
&#xD;
          -  Diabetes.&#xD;
&#xD;
          -  Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease&#xD;
             (e.g. HIV).&#xD;
&#xD;
          -  Employee or family member of the staff of the investigational site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Blue Springs</city>
        <state>Missouri</state>
        <zip>64015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vestal</city>
        <state>New York</state>
        <zip>13850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kittanning</city>
        <state>Pennsylvania</state>
        <zip>16201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02888</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chamberlain</city>
        <state>South Dakota</state>
        <zip>57325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bartlett</city>
        <state>Tennessee</state>
        <zip>38134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>December 9, 2013</results_first_submitted>
  <results_first_submitted_qc>May 5, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 4, 2014</results_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>There were 183 subjects enrolled with 183 subjects randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Delefilcon A \ Etafilcon A</title>
          <description>6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear&#xD;
delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.&#xD;
etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.</description>
        </group>
        <group group_id="P2">
          <title>Etafilcon A \ Delefilcon A</title>
          <description>6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear&#xD;
delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.&#xD;
etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </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="91"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="89"/>
              </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>All enrolled subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>All subjects who were enrolled in the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="183"/>
          </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="31.61" spread="7.061"/>
                  </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="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </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 States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subject Reported Ease of Removal</title>
        <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.</description>
        <time_frame>6-10 Days</time_frame>
        <population>Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Delefilcon A</title>
            <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Reported Ease of Removal</title>
          <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.</description>
          <population>Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2"/>
                    <measurement group_id="O2" value="75.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Reported Overall Comfort</title>
        <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.</description>
        <time_frame>6-10 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delefilcon A</title>
            <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Reported Overall Comfort</title>
          <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.1"/>
                    <measurement group_id="O2" value="61.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Reported Overall Vision</title>
        <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.</description>
        <time_frame>6-10 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Delefilcon A</title>
            <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Reported Overall Vision</title>
          <description>Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1"/>
                    <measurement group_id="O2" value="72.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binocular Snellen Visual Acuity</title>
        <description>Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.</description>
        <time_frame>6-10 Days</time_frame>
        <population>Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.</population>
        <group_list>
          <group group_id="O1">
            <title>Delefilcon A</title>
            <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Binocular Snellen Visual Acuity</title>
          <description>Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.</description>
          <population>Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="360"/>
                <count group_id="O2" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0"/>
                    <measurement group_id="O2" value="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Corneal Staining</title>
        <description>Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.&#xD;
Grade 1 or higher is reported as a percentage of total eyes.</description>
        <time_frame>6-10 Days</time_frame>
        <population>Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.</population>
        <group_list>
          <group group_id="O1">
            <title>Delefilcon A</title>
            <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Corneal Staining</title>
          <description>Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.&#xD;
Grade 1 or higher is reported as a percentage of total eyes.</description>
          <population>Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.</population>
          <units>percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="360"/>
                <count group_id="O2" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4"/>
                    <measurement group_id="O2" value="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study. Approximately 2 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Delefilcon A</title>
          <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
        </group>
        <group group_id="E2">
          <title>Etafilcon A</title>
          <description>Subjects that received the delefilcon A lens in either the first or second period of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </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>Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist</name_or_title>
      <organization>Vistakon</organization>
      <phone>904 443-1032</phone>
      <email>kosborn@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/NCT01669629
org study id: CR-005199
nct id: NCT01669629
lead sponsor: 
has dmc: No
This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a
      primary hypothesis of comparing the handling of each lens. Additional secondary markers are
      measured looking at subjective comfort and vision of the lenses.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Subject Reported Ease of Removal
time frame: 6-10 Days
description: Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
measure: Subject Reported Overall Comfort
time frame: 6-10 Days
description: Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.
measure: Subject Reported Overall Vision
time frame: 6-10 Days
description: Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.
measure: Binocular Snellen Visual Acuity
time frame: 6-10 Days
description: Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.
measure: Overall Corneal Staining
time frame: 6-10 Days
description: Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.
Grade 1 or higher is reported as a percentage of total eyes.
arm group label: Delefilcon A/ Etafilcon A
arm group type: Experimental
description: 6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
arm group label: Etafilcon A / Delefilcon A
arm group type: Experimental
description: 6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
intervention type: Device
intervention name: delefilcon A
description: Daily wear soft contact lens for bilateral distance vision correction use.
arm group label: Delefilcon A/ Etafilcon A
arm group label: Etafilcon A / Delefilcon A
intervention type: Device
intervention name: etafilcon A
description: Daily wear soft contact lens for bilateral distance vision correction use.
arm group label: Delefilcon A/ Etafilcon A
arm group label: Etafilcon A / Delefilcon A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Myopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 