<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/NCT04404725</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-110</org_study_id>
    <nct_id>NCT04404725</nct_id>
  </id_info>
  <brief_title>Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism</brief_title>
  <official_title>Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study was to compare the handling and performance of Biofinity Toric&#xD;
      Multifocal to Ultra Multifocal for Astigmatism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study was to compare the handling and performance of Biofinity Toric&#xD;
      Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized,&#xD;
      participant masked, crossover, bilateral dispensing study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">July 29, 2021</completion_date>
  <primary_completion_date type="Actual">July 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ease of Lens Handling at Insertion</measure>
    <time_frame>Day 28</time_frame>
    <description>Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Astigmatism</condition>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>comfilcon A then samfilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>samfilcon A then comfilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comfilcon A</intervention_name>
    <description>Subjects will be randomized to wear comfilcon A for one month.</description>
    <arm_group_label>comfilcon A then samfilcon A</arm_group_label>
    <arm_group_label>samfilcon A then comfilcon A</arm_group_label>
    <other_name>Biofinity Toric Multifocal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Samfilcon A</intervention_name>
    <description>Subjects will be randomized to wear samfilcon A for one month.</description>
    <arm_group_label>comfilcon A then samfilcon A</arm_group_label>
    <arm_group_label>samfilcon A then comfilcon A</arm_group_label>
    <other_name>Ultra Multifocal for Astigmatism</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is at least 42 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          2. Has read and signed an information consent letter;&#xD;
&#xD;
          3. Self reports having a full eye examination in the previous two years;&#xD;
&#xD;
          4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a&#xD;
             week;&#xD;
&#xD;
          5. Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          6. Habitually wears soft contact lens for the past 3 months minimum;&#xD;
&#xD;
          7. Has refractive astigmatism of at least -0.75DC;&#xD;
&#xD;
          8. Is presbyopic and requires a reading addition of at least +0.75D;&#xD;
&#xD;
          9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20&#xD;
             logMAR) which participants also deem to be 'acceptable', with the available study lens&#xD;
             parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          2. Habitually wears one of the study contact lenses;&#xD;
&#xD;
          3. Has any known active* ocular disease and/or infection;&#xD;
&#xD;
          4. Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          5. Is using any systemic or topical medications that in the opinion of the investigator&#xD;
             may affect contact lens wear or a study outcome variable;&#xD;
&#xD;
          6. Has known sensitivity to the diagnostic sodium fluorescein and/or the care product&#xD;
             Opti-Free PureMoist being used in the study;&#xD;
&#xD;
          7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;&#xD;
&#xD;
          8. Has undergone refractive error surgery. * For the purposes of this study, active&#xD;
             ocular disease is defined as infection or inflammation which requires therapeutic&#xD;
             treatment. Mild (i.e. not considered clinically relevant) lid abnormalities&#xD;
             (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival&#xD;
             staining and dry eye are not considered active ocular disease. Neovascularization and&#xD;
             corneal scars are the result of previous hypoxia, infection or inflammation and are&#xD;
             therefore not active.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD FCOptom</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fiona Soong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eyes on Sheppard Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adam Keech</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oakley Eyecare</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Howard Dolman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dolman Eyecare Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin Heeney</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spadina Optometry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Kreuzer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glasses Half Full</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shane Foster</last_name>
    <role>Principal Investigator</role>
    <affiliation>Athens Eye Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Cymbor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nittany Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Athens Eye care</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nittany Eye Associates</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glasses Half Full</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5N1S5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakley Eyecare</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2C 3B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dolman Eyecare Centre</name>
      <address>
        <city>New Hamburg</city>
        <state>Ontario</state>
        <zip>N3A 1K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spadina Optometry</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5V 2K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndon Jones</name>
      <address>
        <city>Waterloo</city>
        <state>Ontorio</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>January 20, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2022</results_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</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>Astigmatism</mesh_term>
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT04404725/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Comfilcon A Then Samfilcon A</title>
          <description>Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.&#xD;
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.&#xD;
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.</description>
        </group>
        <group group_id="P2">
          <title>Samfilcon A Then Comfilcon A</title>
          <description>Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.&#xD;
comfilcon A: Subjects will be randomized to wear comfilcon A for one month.&#xD;
Samfilcon A: Subjects will be randomized to wear samfilcon A for one month.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants.&#xD;
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.9" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ease of Lens Handling at Insertion</title>
        <description>Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).</description>
        <time_frame>Day 28</time_frame>
        <population>Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.</description>
          </group>
          <group group_id="O2">
            <title>Samfilcon A</title>
            <description>Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.</description>
          </group>
        </group_list>
        <measure>
          <title>Ease of Lens Handling at Insertion</title>
          <description>Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).</description>
          <population>Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations.</population>
          <units>score 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="55"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="1.6"/>
                    <measurement group_id="O2" value="8.8" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One month on each study lenses, a total of two months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comfilcon A</title>
          <description>Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study.</description>
        </group>
        <group group_id="E2">
          <title>Samfilcon A</title>
          <description>Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study.</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>conjunctivitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Infiltrative Keratitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Ocular Event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jose Vega, OD, MSc, FAAO</name_or_title>
      <organization>CooperVision, Inc</organization>
      <phone>9256213761</phone>
      <email>JVega2@coopervision.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04404725
org study id: EX-MKTG-110
nct id: NCT04404725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the study was to compare the handling and performance of Biofinity Toric
      Multifocal to Ultra Multifocal for Astigmatism.
The objective of the study was to compare the handling and performance of Biofinity Toric
      Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized,
      participant masked, crossover, bilateral dispensing study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Ease of Lens Handling at Insertion
time frame: Day 28
description: Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
arm group label: comfilcon A then samfilcon A
arm group type: Experimental
description: Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
arm group label: samfilcon A then comfilcon A
arm group type: Active Comparator
description: Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.
intervention type: Device
intervention name: comfilcon A
description: Subjects will be randomized to wear comfilcon A for one month.
arm group label: comfilcon A then samfilcon A
arm group label: samfilcon A then comfilcon A
other name: Biofinity Toric Multifocal
intervention type: Device
intervention name: Samfilcon A
description: Subjects will be randomized to wear samfilcon A for one month.
arm group label: comfilcon A then samfilcon A
arm group label: samfilcon A then comfilcon A
other name: Ultra Multifocal for Astigmatism
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lyndon Jones, PhD FCOptom
role: Principal Investigator
affiliation: University of Waterloo
last name: Fiona Soong
role: Principal Investigator
affiliation: Eyes on Sheppard Clinic
last name: Adam Keech
role: Principal Investigator
affiliation: Oakley Eyecare
last name: Howard Dolman
role: Principal Investigator
affiliation: Dolman Eyecare Centre
last name: Kristin Heeney
role: Principal Investigator
affiliation: Spadina Optometry
last name: Michael Kreuzer
role: Principal Investigator
affiliation: Glasses Half Full
last name: Shane Foster
role: Principal Investigator
affiliation: Athens Eye Care
last name: Michael Cymbor
role: Principal Investigator
affiliation: Nittany Eye Associates
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
mesh term: Presbyopia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 