<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/NCT03762668</url>
  </required_header>
  <id_info>
    <org_study_id>CLP691-C002</org_study_id>
    <nct_id>NCT03762668</nct_id>
  </id_info>
  <brief_title>Performance Assessment of a Modified Daily Disposable Contact Lens</brief_title>
  <official_title>Performance Assessment of a Modified Daily Disposable 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 compare visual acuity between two daily disposable contact&#xD;
      lenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The expected duration of subject participation in the study is approximately 2 weeks, with 3&#xD;
      scheduled visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">January 7, 2019</completion_date>
  <primary_completion_date type="Actual">January 7, 2019</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>High Contrast Distance Visual Acuity (logMAR)</measure>
    <time_frame>Day 1 Dispense, Day 7 Follow-Up</time_frame>
    <description>Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Myopia</condition>
  <condition>Hyperopia</condition>
  <arm_group>
    <arm_group_label>MDACL, then DACL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DACL, then MDACL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Modified delefilcon A contact lenses</intervention_name>
    <description>Spherical soft daily disposable contact lens</description>
    <arm_group_label>DACL, then MDACL</arm_group_label>
    <arm_group_label>MDACL, then DACL</arm_group_label>
    <other_name>MDACL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Delefilcon A contact lenses</intervention_name>
    <description>Spherical soft daily disposable contact lens</description>
    <arm_group_label>DACL, then MDACL</arm_group_label>
    <arm_group_label>MDACL, then DACL</arm_group_label>
    <other_name>DACL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign an approved Informed Consent form;&#xD;
&#xD;
          -  Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any eye condition that contraindicates contact lens wear, as determined by the&#xD;
             Investigator;&#xD;
&#xD;
          -  Any eye surgery that contraindicates contact lens wear, as determined by the&#xD;
             Investigator;&#xD;
&#xD;
          -  Wears habitual contact lenses in an extended wear modality (routinely sleeping in&#xD;
             lenses for at least 1 night per week)&#xD;
&#xD;
          -  Monocular (only one eye with functional vision);&#xD;
&#xD;
          -  Other protocol-specified 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. CDMA Project Lead, Vision Care</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</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>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</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>January 2020</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>December 19, 2019</results_first_submitted>
  <results_first_submitted_qc>December 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2020</results_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contact lens</keyword>
  <keyword>Vision correction</keyword>
  <keyword>Visual acuity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
    <mesh_term>Hyperopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03762668/SAP_000.pdf</document_url>
    </provided_document>
    <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>November 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03762668/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 5 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MDACL, Then DACL</title>
          <description>Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.</description>
        </group>
        <group group_id="P2">
          <title>DACL, Then MDACL</title>
          <description>DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1, First Week of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <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="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2, Second Week of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <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="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).</population>
      <group_list>
        <group group_id="B1">
          <title>MDACL, Then DACL</title>
          <description>MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.</description>
        </group>
        <group group_id="B2">
          <title>DACL, Then MDACL</title>
          <description>DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="32.7" spread="9.3"/>
                    <measurement group_id="B2" value="30.7" spread="8.6"/>
                    <measurement group_id="B3" value="31.7" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="54"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="55"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>High Contrast Distance Visual Acuity (logMAR)</title>
        <description>Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.</description>
        <time_frame>Day 1 Dispense, Day 7 Follow-Up</time_frame>
        <population>All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>MDACL</title>
            <description>MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized</description>
          </group>
          <group group_id="O2">
            <title>DACL</title>
            <description>DACL worn for approximately 1 week, Period 1 or Period 2, as randomized</description>
          </group>
        </group_list>
        <measure>
          <title>High Contrast Distance Visual Acuity (logMAR)</title>
          <description>Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.</description>
          <population>All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 Dispense</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.07"/>
                    <measurement group_id="O2" value="-0.04" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.07"/>
                    <measurement group_id="O2" value="-0.05" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.</non_inferiority_desc>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.005</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>test minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.</time_frame>
      <desc>An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study lenses. This analysis population includes all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).</desc>
      <group_list>
        <group group_id="E1">
          <title>MDACL</title>
          <description>MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized</description>
        </group>
        <group group_id="E2">
          <title>DACL</title>
          <description>DACL worn for approximately 1 week, Period 1 or Period 2, as randomized</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="60"/>
              </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="60"/>
              </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="60"/>
              </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>Sr. 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/NCT03762668
org study id: CLP691-C002
nct id: NCT03762668
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 compare visual acuity between two daily disposable contact
      lenses.
The expected duration of subject participation in the study is approximately 2 weeks, with 3
      scheduled visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: High Contrast Distance Visual Acuity (logMAR)
time frame: Day 1 Dispense, Day 7 Follow-Up
description: Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
arm group label: MDACL, then DACL
arm group type: Other
description: Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
arm group label: DACL, then MDACL
arm group type: Other
description: DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
intervention type: Device
intervention name: Modified delefilcon A contact lenses
description: Spherical soft daily disposable contact lens
arm group label: DACL, then MDACL
arm group label: MDACL, then DACL
other name: MDACL
intervention type: Device
intervention name: Delefilcon A contact lenses
description: Spherical soft daily disposable contact lens
arm group label: DACL, then MDACL
arm group label: MDACL, then DACL
other name: DACL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. CDMA Project Lead, Vision Care
role: Study Director
affiliation: Alcon Research
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
mesh term: Hyperopia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 