<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/NCT04449263</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-109</org_study_id>
    <nct_id>NCT04449263</nct_id>
  </id_info>
  <brief_title>Comparing the Performance of 1 Day Multifocal Contact Lenses</brief_title>
  <official_title>Comparing the Performance of 1 Day Multifocal 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>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 lens handling and performance of Lens A to&#xD;
      habitually worn multifocal contact lenses and to the competitor Lens B.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study was to compare the lens handling and performance of Lens A to&#xD;
      habitually worn multifocal contact lenses and to the competitor Lens B. This was a&#xD;
      prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted&#xD;
      at up to 5 clinical practice sites in the United States. Subjects were dispensed their&#xD;
      habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens&#xD;
      type will be worn for 2 weeks after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</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>Subjective At-home Ratings for Ease of Lens Handling for Insertion</measure>
    <time_frame>Day 13</time_frame>
    <description>Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Lens A (Test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lens B (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Habitual Lenses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lens A</intervention_name>
    <description>Subjects will be randomized to wear Lens A (test) for 2 weeks.</description>
    <arm_group_label>Lens A (Test)</arm_group_label>
    <arm_group_label>Lens B (Control)</arm_group_label>
    <other_name>FDA Approved, non-marketed, daily disposable multifocal lens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lens B</intervention_name>
    <description>Subjects will be randomized to wear Lens B (control) for 2 weeks.</description>
    <arm_group_label>Lens A (Test)</arm_group_label>
    <arm_group_label>Lens B (Control)</arm_group_label>
    <other_name>FDA Approved, daily disposable multifocal lens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Habitual Lenses</intervention_name>
    <description>All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.</description>
    <arm_group_label>Habitual Lenses</arm_group_label>
    <arm_group_label>Lens A (Test)</arm_group_label>
    <arm_group_label>Lens B (Control)</arm_group_label>
  </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 multifocal soft contact lenses, for the past 3 months minimum;&#xD;
&#xD;
          7. Has refractive astigmatism no higher than -0.75DC;&#xD;
&#xD;
          8. Is presbyopic and requires a reading addition of at least +0.75D and no more than&#xD;
             +2.50D;&#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; near addition or LOW, MEDIUM, HIGH).&#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 that contraindicates contact&#xD;
             lens wear;&#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 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 or intraocular surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Golden</last_name>
    <role>Principal Investigator</role>
    <affiliation>Golden Vision</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Keith Wan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Poway Eyecare</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shane Kannarr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kannarr Eye Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Ardaya</last_name>
    <role>Principal Investigator</role>
    <affiliation>Golden Optometric Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine Bickle</last_name>
    <role>Principal Investigator</role>
    <affiliation>ProCare Vision Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Poway Eyecare</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Optometric Group</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Vision</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannarr Eye Care</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProCare Vision Center</name>
      <address>
        <city>Granville</city>
        <state>Ohio</state>
        <zip>43023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <results_first_submitted>May 26, 2021</results_first_submitted>
  <results_first_submitted_qc>May 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2021</results_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</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>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>June 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT04449263/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>60 subjects were enrolled and 1 subject discontinued because of screen failure prior to dispense of their habitual lenses.</recruitment_details>
      <pre_assignment_details>All 59 subjects wore their habitual lenses for two weeks prior to randomization to test lens and control lens.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lens A (Test) Then Lens B (Control)</title>
          <description>Subjects wore their habitual lenses for 2 weeks and were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact lens: Habitual Lenses Contact Lens: Test Lens A Contact Lens: Control Lens B</description>
        </group>
        <group group_id="P2">
          <title>Lens B (Control) Then Lens A (Test)</title>
          <description>All Subjects wore their habitual lenses for 2 weeks prior to randomization and were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact Lens: Habitual lenses&#xD;
Contact lens: Control Lens B&#xD;
Contact Lens : Test lens A</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </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</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </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>Third Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
          </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="59"/>
                  </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="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.5" spread="7.3"/>
                  </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="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </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>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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective At-home Ratings for Ease of Lens Handling for Insertion</title>
        <description>Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)</description>
        <time_frame>Day 13</time_frame>
        <population>One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Habitual Lenses</title>
            <description>Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.&#xD;
Contact Lenses: Habitual Lenses</description>
          </group>
          <group group_id="O2">
            <title>Lens A (Test)</title>
            <description>Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact Lens: Test Lens A</description>
          </group>
          <group group_id="O3">
            <title>Lens B (Control)</title>
            <description>Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact lens: Control Lens B</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective At-home Ratings for Ease of Lens Handling for Insertion</title>
          <description>Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)</description>
          <population>One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.</population>
          <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="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.90" spread="1.59"/>
                    <measurement group_id="O2" value="8.28" spread="2.10"/>
                    <measurement group_id="O3" value="9.18" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All subjects wore their habitual lenses for two weeks and then randomized to wear test lens A and control lens B for 2 weeks, a total of 6 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Subjects Habitual Lenses</title>
          <description>All Subjects wore their habitual lenses for 2 weeks prior to randomization of test lens and control lens.&#xD;
Contact Lenses: Habitual Lenses</description>
        </group>
        <group group_id="E2">
          <title>Lens A (Test)</title>
          <description>Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact Lens: Test Lens A</description>
        </group>
        <group group_id="E3">
          <title>Lens B (Control)</title>
          <description>Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.&#xD;
Contact lens: Control Lens B</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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
              </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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="59"/>
              </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>9256402964</phone>
      <email>javega2@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/NCT04449263
org study id: EX-MKTG-109
nct id: NCT04449263
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 lens handling and performance of Lens A to
      habitually worn multifocal contact lenses and to the competitor Lens B.
The objective of the study was to compare the lens handling and performance of Lens A to
      habitually worn multifocal contact lenses and to the competitor Lens B. This was a
      prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted
      at up to 5 clinical practice sites in the United States. Subjects were dispensed their
      habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens
      type will be worn for 2 weeks after randomization.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Subjective At-home Ratings for Ease of Lens Handling for Insertion
time frame: Day 13
description: Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
arm group label: Lens A (Test)
arm group type: Experimental
description: Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.
arm group label: Lens B (Control)
arm group type: Active Comparator
description: Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.
arm group label: Habitual Lenses
arm group type: Active Comparator
description: All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.
intervention type: Device
intervention name: Lens A
description: Subjects will be randomized to wear Lens A (test) for 2 weeks.
arm group label: Lens A (Test)
arm group label: Lens B (Control)
other name: FDA Approved, non-marketed, daily disposable multifocal lens
intervention type: Device
intervention name: Lens B
description: Subjects will be randomized to wear Lens B (control) for 2 weeks.
arm group label: Lens A (Test)
arm group label: Lens B (Control)
other name: FDA Approved, daily disposable multifocal lens
intervention type: Device
intervention name: Habitual Lenses
description: All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
arm group label: Habitual Lenses
arm group label: Lens A (Test)
arm group label: Lens B (Control)
criteria: 
gender: All
minimum age: 42 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wayne Golden
role: Principal Investigator
affiliation: Golden Vision
last name: Keith Wan
role: Principal Investigator
affiliation: Scripps Poway Eyecare
last name: Shane Kannarr
role: Principal Investigator
affiliation: Kannarr Eye Care
last name: David Ardaya
role: Principal Investigator
affiliation: Golden Optometric Group
last name: Katherine Bickle
role: Principal Investigator
affiliation: ProCare Vision Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 