<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/NCT02196766</url>
  </required_header>
  <id_info>
    <org_study_id>CVJ-EX-MKTG-1818</org_study_id>
    <nct_id>NCT02196766</nct_id>
  </id_info>
  <brief_title>BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens</brief_title>
  <official_title>BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if patients are unreactive to the lens care solution / Biofinity combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine if patients are unreactive to the lens care solution / Biofinity combination in&#xD;
      this cross-over study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Health - Corneal Staining</measure>
    <time_frame>1 week</time_frame>
    <description>Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Health - Conjunctival Redness</measure>
    <time_frame>1 week</time_frame>
    <description>Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Health - Limbal Redness</measure>
    <time_frame>1 week</time_frame>
    <description>Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Health - Papillary Conjunctivitis</measure>
    <time_frame>1 week</time_frame>
    <description>Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stinging Sensation Right After Insertion (Subjective Rating)</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burning Sensation Right After Insertion (Subjective Rating)</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Bioclean First Care EX combo, then Aosept Clearcare combo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aosept Clearcare combo, then Bioclean First Care EX combo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bioclean First Care EX / comfilcon A</intervention_name>
    <description>Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.</description>
    <arm_group_label>Aosept Clearcare combo, then Bioclean First Care EX combo</arm_group_label>
    <arm_group_label>Bioclean First Care EX combo, then Aosept Clearcare combo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aosept Clearcare / comfilcon A</intervention_name>
    <description>Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.</description>
    <arm_group_label>Aosept Clearcare combo, then Bioclean First Care EX combo</arm_group_label>
    <arm_group_label>Bioclean First Care EX combo, then Aosept Clearcare combo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is over 18 years of age (inclusive)&#xD;
&#xD;
          -  Has had a self-reported visual exam in the last two years&#xD;
&#xD;
          -  Is currently an adapted spherical soft CL wearer&#xD;
&#xD;
          -  Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)&#xD;
&#xD;
          -  Has less than 1.00D spectacle cylinder in each eye.&#xD;
&#xD;
          -  Is correctable to a visual acuity of 20/20 or better in both eyes&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Has read, understood and signed the information consent letter.&#xD;
&#xD;
          -  Is willing to comply with the wear schedule (at least 40 hrs per week)&#xD;
&#xD;
          -  Is willing to comply with the visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has never worn contact lenses before.&#xD;
&#xD;
          -  Currently wears rigid gas permeable contact lenses.&#xD;
&#xD;
          -  Has a history of not achieving comfortable CL wear (5 days per week; &gt; 8 hours/day)&#xD;
&#xD;
          -  Has a CL prescription outside the range of - 0.25 to -12.00D&#xD;
&#xD;
          -  Has a spectacle cylinder greater than -0.75D of cylinder in either eye.&#xD;
&#xD;
          -  Has best corrected spectacle distance vision worse than 20/20 in either eye.&#xD;
&#xD;
          -  Has any systemic disease affecting ocular health.&#xD;
&#xD;
          -  Is using any systemic or topical medications that will affect ocular health.&#xD;
&#xD;
          -  Has any ocular pathology or severe insufficiency of lacrimal secretion&#xD;
&#xD;
          -  Has persistent, clinically significant corneal or conjunctival staining&#xD;
&#xD;
          -  Has active neovascularization or any central corneal scars.&#xD;
&#xD;
          -  Is aphakic.&#xD;
&#xD;
          -  Is pregnant or lactating.&#xD;
&#xD;
          -  Has undergone corneal refractive surgery.&#xD;
&#xD;
          -  Is participating in any other type of eye related clinical or research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taku Muraoka, OD</last_name>
    <role>Study Director</role>
    <affiliation>Director Professional Services, CVI Japan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kokama Eye Clinic</name>
      <address>
        <city>Joyo-shi</city>
        <state>Kyoto-fu</state>
        <zip>610-0121</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Higashihara Clinic</name>
      <address>
        <city>Kameoka</city>
        <state>Kyoto-fu</state>
        <zip>621-0861</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dougenzaka Ioti Eye Clinic</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo-to</state>
        <zip>150-0043</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>December 15, 2015</results_first_submitted>
  <results_first_submitted_qc>March 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 29, 2016</results_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bioclean First Care EX Combo, Then Aosept Clearcare Combo</title>
          <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
        </group>
        <group group_id="P2">
          <title>Aosept Clearcare Combo First,Then Bioclean First Care EX Combo</title>
          <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </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>Overall participants group prior to randomization of study lens pairs and solution.</population>
      <group_list>
        <group group_id="B1">
          <title>Bioclean First Care EX / Aosept Clearcare / Comfil</title>
          <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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" spread="7.4"/>
                  </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="9"/>
                  </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>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Health - Corneal Staining</title>
        <description>Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Health - Corneal Staining</title>
          <description>Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
          <units>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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stinging Sensation Right After Insertion (Subjective Rating)</title>
        <description>Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging Sensation Right After Insertion (Subjective Rating)</title>
          <description>Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="1.1"/>
                    <measurement group_id="O2" value="9.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Burning Sensation Right After Insertion (Subjective Rating)</title>
        <description>Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Burning Sensation Right After Insertion (Subjective Rating)</title>
          <description>Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="1.1"/>
                    <measurement group_id="O2" value="9.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Health - Conjunctival Redness</title>
        <description>Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Health - Conjunctival Redness</title>
          <description>Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
          <units>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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Health - Limbal Redness</title>
        <description>Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Health - Limbal Redness</title>
          <description>Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
          <units>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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Health - Papillary Conjunctivitis</title>
        <description>Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bioclean First Care EX / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
          <group group_id="O2">
            <title>Aosept Clearcare / Comfilcon A</title>
            <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Health - Papillary Conjunctivitis</title>
          <description>Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).</description>
          <units>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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to two weeks for study lenses with both study lens care solutions</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bioclean First Care EX / Comfilcon A</title>
          <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</description>
        </group>
        <group group_id="E2">
          <title>Aosept Clearcare / Comfilcon A</title>
          <description>Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.&#xD;
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Principal Investigators are NOT employed by the organization sponsoring the study.&#xD;
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.&#xD;
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Taku Muraoka, OD, Director Professional Services Organization</name_or_title>
      <organization>Coopervision Japan</organization>
      <phone>81-3-5449-6619</phone>
      <email>taku.muraoka@jp.coopervision.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02196766
org study id: CVJ-EX-MKTG-1818
nct id: NCT02196766
lead sponsor: 
has dmc: No
To determine if patients are unreactive to the lens care solution / Biofinity combination.
To determine if patients are unreactive to the lens care solution / Biofinity combination in
      this cross-over study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Ocular Health - Corneal Staining
time frame: 1 week
description: Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
measure: Ocular Health - Conjunctival Redness
time frame: 1 week
description: Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
measure: Ocular Health - Limbal Redness
time frame: 1 week
description: Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
measure: Ocular Health - Papillary Conjunctivitis
time frame: 1 week
description: Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
measure: Stinging Sensation Right After Insertion (Subjective Rating)
time frame: Baseline
description: Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
measure: Burning Sensation Right After Insertion (Subjective Rating)
time frame: Baseline
description: Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
arm group label: Bioclean First Care EX combo, then Aosept Clearcare combo
arm group type: Active Comparator
description: Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.
arm group label: Aosept Clearcare combo, then Bioclean First Care EX combo
arm group type: Active Comparator
description: Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.
intervention type: Other
intervention name: Bioclean First Care EX / comfilcon A
description: Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
arm group label: Aosept Clearcare combo, then Bioclean First Care EX combo
arm group label: Bioclean First Care EX combo, then Aosept Clearcare combo
intervention type: Other
intervention name: Aosept Clearcare / comfilcon A
description: Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
arm group label: Aosept Clearcare combo, then Bioclean First Care EX combo
arm group label: Bioclean First Care EX combo, then Aosept Clearcare combo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Taku Muraoka, OD
role: Study Director
affiliation: Director Professional Services, CVI Japan
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Myopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 