<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/NCT04476784</url>
  </required_header>
  <id_info>
    <org_study_id>CLY935-C013</org_study_id>
    <nct_id>NCT04476784</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens</brief_title>
  <official_title>Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the clinical performance of an investigational contact&#xD;
      lens over 30 days of daily wear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will wear two products and be expected to attend 4 office visits. The individual&#xD;
      duration of participation will be approximately 60 days (30 days for each product).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">November 18, 2020</completion_date>
  <primary_completion_date type="Actual">November 18, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Distance Visual Acuity (logMAR) With Study Lenses</measure>
    <time_frame>Day 1, Day 30 after 6-8 hours of wear, each product</time_frame>
    <description>Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>LID018869, then Biofinity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofinity, then LID018869</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lehfilcon A contact lenses</intervention_name>
    <description>Investigational silicone hydrogel contact lenses</description>
    <arm_group_label>Biofinity, then LID018869</arm_group_label>
    <arm_group_label>LID018869, then Biofinity</arm_group_label>
    <other_name>LID018869</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comfilcon A contact lenses</intervention_name>
    <description>Commercially available silicone hydrogel contact lenses</description>
    <arm_group_label>Biofinity, then LID018869</arm_group_label>
    <arm_group_label>LID018869, then Biofinity</arm_group_label>
    <other_name>CooperVision® BIOFINITY®</other_name>
    <other_name>Biofinity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CLEAR CARE</intervention_name>
    <description>Hydrogen peroxide-based cleaning and disinfecting solution</description>
    <arm_group_label>Biofinity, then LID018869</arm_group_label>
    <arm_group_label>LID018869, then Biofinity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign an approved Informed Consent form;&#xD;
&#xD;
          -  Willing and able to attend all scheduled study visits as required by the protocol;&#xD;
&#xD;
          -  Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at&#xD;
             least 3 months wearing time of 5 days per week and 10 hours per day;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior Biofinity contact lens wearer in the past 3 months;&#xD;
&#xD;
          -  Monovision contact lens wearer;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sr. Clinical Trial Lead, CDMA Vision Care</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <results_first_submitted>September 29, 2021</results_first_submitted>
  <results_first_submitted_qc>September 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2021</results_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contact lenses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04476784/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04476784/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at 5 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>This reporting group includes all subjects/eyes (66/132) exposed to any study lenses evaluated in this study as treated (Safety Analysis Set)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LID018869, Then Biofinity</title>
          <description>Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</description>
        </group>
        <group group_id="P2">
          <title>Biofinity, Then LID018869</title>
          <description>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Wear Period (30 Days ± 2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Wear Period (30 Days ± 2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="35"/>
              </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>Safety Analysis Set</population>
      <group_list>
        <group group_id="B1">
          <title>LID018869, Then Biofinity</title>
          <description>Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</description>
        </group>
        <group group_id="B2">
          <title>Biofinity, Then LID018869</title>
          <description>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</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="31"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" spread="8.0"/>
                    <measurement group_id="B2" value="33.7" spread="8.7"/>
                    <measurement group_id="B3" value="33.2" spread="8.3"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Distance Visual Acuity (logMAR) With Study Lenses</title>
        <description>Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
        <time_frame>Day 1, Day 30 after 6-8 hours of wear, each product</time_frame>
        <population>Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>LID018869</title>
            <description>Lehfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</description>
          </group>
          <group group_id="O2">
            <title>Biofinity</title>
            <description>Comfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Distance Visual Acuity (logMAR) With Study Lenses</title>
          <description>Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
          <population>Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.08"/>
                    <measurement group_id="O2" value="-0.13" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30, after 6-8 hours of wear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.07"/>
                    <measurement group_id="O2" value="-0.13" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AE's) were collected from time of consent to study exit, approximately 60 days.</time_frame>
      <desc>AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. &quot;At Risk&quot; population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study. For treatment-emergent safety analyses, subjects/eyes were categorized under the actual study lenses exposed in the corresponding lens sequence.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pretreatment</title>
          <description>Events reported in this group occurred prior to exposure to the study contact lenses</description>
        </group>
        <group group_id="E2">
          <title>LID018869 - Ocular</title>
          <description>Events reported in this group occurred while exposed to lehfilcon A contact lenses</description>
        </group>
        <group group_id="E3">
          <title>LID018869 - Nonocular</title>
          <description>Events reported in this group occurred while exposed to lehfilcon A contact lenses</description>
        </group>
        <group group_id="E4">
          <title>Biofinity - Ocular</title>
          <description>Events reported in this group occurred while exposed to comfilcon A contact lenses</description>
        </group>
        <group group_id="E5">
          <title>Biofinity - Nonocular</title>
          <description>Events reported in this group occurred while exposed to comfilcon A contact lenses</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="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="65"/>
              </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="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="65"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>CDMA Project Lead, Vision Care</name_or_title>
      <organization>Alcon Research, LLC</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.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/NCT04476784
org study id: CLY935-C013
nct id: NCT04476784
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to assess the clinical performance of an investigational contact
      lens over 30 days of daily wear.
Subjects will wear two products and be expected to attend 4 office visits. The individual
      duration of participation will be approximately 60 days (30 days for each product).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Distance Visual Acuity (logMAR) With Study Lenses
time frame: Day 1, Day 30 after 6-8 hours of wear, each product
description: Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
arm group label: LID018869, then Biofinity
arm group type: Other
description: Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
arm group label: Biofinity, then LID018869
arm group type: Other
description: Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.
intervention type: Device
intervention name: Lehfilcon A contact lenses
description: Investigational silicone hydrogel contact lenses
arm group label: Biofinity, then LID018869
arm group label: LID018869, then Biofinity
other name: LID018869
intervention type: Device
intervention name: Comfilcon A contact lenses
description: Commercially available silicone hydrogel contact lenses
arm group label: Biofinity, then LID018869
arm group label: LID018869, then Biofinity
other name: CooperVision® BIOFINITY®
other name: Biofinity
intervention type: Device
intervention name: CLEAR CARE
description: Hydrogen peroxide-based cleaning and disinfecting solution
arm group label: Biofinity, then LID018869
arm group label: LID018869, then Biofinity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. Clinical Trial Lead, CDMA Vision Care
role: Study Director
affiliation: Alcon Research, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 