<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/NCT01707238</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-39</org_study_id>
    <nct_id>NCT01707238</nct_id>
  </id_info>
  <brief_title>Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses</brief_title>
  <official_title>Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the subjective performance for handling of two daily&#xD;
      disposable contact lenses, stenfilcon A and etafilcon A.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is to compare the subjective performance for handling of two daily disposable&#xD;
      contact lenses, stenfilcon A and etafilcon A in this cross-over study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Handling</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction With Handling</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comfort</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dryness</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Dryness</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Comfort</measure>
    <time_frame>two weeks and four weeks from baseline visit</time_frame>
    <description>Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>stenfilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>etafilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon A</intervention_name>
    <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
    <arm_group_label>stenfilcon A</arm_group_label>
    <other_name>etafilcon A (Daily Disposable Contact Lens)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>stenfilcon A</intervention_name>
    <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
    <arm_group_label>etafilcon A</arm_group_label>
    <other_name>stenfilcon A (Daily Disposable Contact Lens)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:-&#xD;
&#xD;
          -  Be between 16 and 45 years of age (inclusive)&#xD;
&#xD;
          -  Adapted soft contact lens (CL) wearers (i.e. &gt; 1 month)&#xD;
&#xD;
          -  Spherical distance CL prescription between -1.00 and -6.00D (inclusive)&#xD;
&#xD;
          -  Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.&#xD;
&#xD;
          -  Correctable to 6/9 (20/30) in both eyes&#xD;
&#xD;
          -  Have the use of a mobile phone to send and receive text messages throughout the day&#xD;
             for the duration of the study.&#xD;
&#xD;
          -  Have read, understood and signed the informed consent&#xD;
&#xD;
          -  Willing to comply with the wear schedule (at least 40 hours per week)&#xD;
&#xD;
          -  Willing to comply with the study visit schedule&#xD;
&#xD;
        Exclusion Criteria:-&#xD;
&#xD;
          -  Any active corneal infection, injury or inflammation&#xD;
&#xD;
          -  Systemic or ocular allergies, which might interfere with CL wear&#xD;
&#xD;
          -  Systemic disease, which might interfere with CL wear&#xD;
&#xD;
          -  Ocular disease, which might interfere with CL wear&#xD;
&#xD;
          -  Strabismus, amblyopia&#xD;
&#xD;
          -  Subjects who have undergone corneal refractive surgery and any anterior segment&#xD;
             surgery&#xD;
&#xD;
          -  Subjects with keratoconus or other severe corneal irregularity contraindicating lens&#xD;
             wear&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Use of systemic/topical medication contraindicating CL wear&#xD;
&#xD;
          -  Use of gas permeable contact lenses within the last month&#xD;
&#xD;
          -  Employees of the investigational site or immediate family members of Investigators&#xD;
&#xD;
          -  Participation in any concurrent clinical trial or in the last 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graeme Young</last_name>
    <role>Study Director</role>
    <affiliation>Visioncare Research Ltd.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruth Craven</last_name>
    <role>Study Director</role>
    <affiliation>Visioncare Research Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keith Tempany Opticians</name>
      <address>
        <city>Broadstone</city>
        <state>Dorset</state>
        <zip>MH18</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cameron-Davies Optometrists</name>
      <address>
        <city>Southsea</city>
        <state>Hampshire</state>
        <zip>PO5 2AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cameron-Davies Optometrists</name>
      <address>
        <city>Portchester</city>
        <state>Hants</state>
        <zip>PO16 9UN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leightons Opticians</name>
      <address>
        <city>St. Albans</city>
        <state>Hertfordshire</state>
        <zip>AL1 3LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Gould Opticians</name>
      <address>
        <city>Rawtenstall</city>
        <state>Lancashire</state>
        <zip>BB4 7QN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision Express Optical Lab</name>
      <address>
        <city>Hendon</city>
        <state>London</state>
        <zip>NW4 3FB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.H. Harrold</name>
      <address>
        <city>Uxbridge</city>
        <state>London</state>
        <zip>UB8 1JX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>April 1, 2014</results_first_submitted>
  <results_first_submitted_qc>August 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 27, 2014</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">August 3, 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>
      <recruitment_details>Number subjects enrolled per site ranged six to 25. Two sites were asked to enroll more than 20 subjects to fulfill required number of subjects. Approval from Ethics Committee sought before sites were invited to recruit additional subjects. Of the 100 enrolled, 13 were existing etafilcon A wearers, falling short of the 25% target.</recruitment_details>
      <pre_assignment_details>All participants randomized to receive all interventions and combined into one Arm/Group, &quot;Overall All Study Population&quot; for the participant flow.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Stenfilcon A Then Etafilcon A</title>
          <description>All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.</description>
        </group>
        <group group_id="P2">
          <title>Etafilcon A Then Stenfilcon A</title>
          <description>All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="52"/>
              </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 subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.</population>
      <group_list>
        <group group_id="B1">
          <title>Stenfilcon A Then Etafilcon A</title>
          <description>All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.</description>
        </group>
        <group group_id="B2">
          <title>Etafilcon A Then Stenfilcon A</title>
          <description>All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="48"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="31"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </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="48"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Handling</title>
        <description>Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Handling</title>
          <description>Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.84" spread="1.56"/>
                    <measurement group_id="O2" value="6.76" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort</title>
        <description>Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort</title>
          <description>Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.84" spread="1.32"/>
                    <measurement group_id="O2" value="8.09" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dryness</title>
        <description>Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Dryness</title>
          <description>Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.51" spread="1.81"/>
                    <measurement group_id="O2" value="8.07" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction With Handling</title>
        <description>Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Handling</title>
          <description>Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completely Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" spread="0.85"/>
                    <measurement group_id="O2" value="28" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somwhat Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completely Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Dryness</title>
        <description>Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Dryness</title>
          <description>Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completely Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="0.91"/>
                    <measurement group_id="O2" value="35" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somwhat Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completely Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Comfort</title>
        <description>Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</description>
        <time_frame>two weeks and four weeks from baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Stenfilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
          <group group_id="O2">
            <title>Etafilcon A</title>
            <description>Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Comfort</title>
          <description>Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completely Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" spread="0.82"/>
                    <measurement group_id="O2" value="51" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somwhat Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completely Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Stenfilcon A</title>
          <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
        </group>
        <group group_id="E2">
          <title>Etafilcon A</title>
          <description>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </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 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>Graeme Young</name_or_title>
      <organization>Visioncare Research Ltd.</organization>
      <phone>01252 718719 ext 207</phone>
      <email>g.young@visioncare.co.uk</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/NCT01707238
org study id: EX-MKTG-39
nct id: NCT01707238
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the subjective performance for handling of two daily
      disposable contact lenses, stenfilcon A and etafilcon A.
The study is to compare the subjective performance for handling of two daily disposable
      contact lenses, stenfilcon A and etafilcon A in this cross-over study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Handling
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
measure: Satisfaction With Handling
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
measure: Comfort
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).
measure: Dryness
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).
measure: Satisfaction With Dryness
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
measure: Satisfaction With Comfort
time frame: two weeks and four weeks from baseline visit
description: Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
arm group label: stenfilcon A
arm group type: Experimental
description: Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
arm group label: etafilcon A
arm group type: Active Comparator
description: Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
intervention type: Device
intervention name: etafilcon A
description: Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
arm group label: stenfilcon A
other name: etafilcon A (Daily Disposable Contact Lens)
intervention type: Device
intervention name: stenfilcon A
description: Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
arm group label: etafilcon A
other name: stenfilcon A (Daily Disposable Contact Lens)
criteria: 
gender: All
minimum age: 16 Years
maximum age: 45 Years
healthy volunteers: No
last name: Graeme Young
role: Study Director
affiliation: Visioncare Research Ltd.
last name: Ruth Craven
role: Study Director
affiliation: Visioncare Research Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Myopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 