<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/NCT03779503</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-99 (C18-649)</org_study_id>
    <nct_id>NCT03779503</nct_id>
  </id_info>
  <brief_title>Comparison of Two Daily Disposable Soft Contact Lenses</brief_title>
  <official_title>A Clinical Comparison of Two Daily Disposable Soft 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 aim of this study was to investigate the short-term clinical performance and subjective&#xD;
      acceptance of the two study lenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled&#xD;
      by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week&#xD;
      in random order. Lenses were worn on a daily wear, daily disposable basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">September 18, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 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>Lens Fit - Horizontal Centration</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Horizontal Centration</measure>
    <time_frame>One Week</time_frame>
    <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Vertical Centration</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Vertical Centration</measure>
    <time_frame>One Week</time_frame>
    <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Corneal Coverage</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Corneal Coverage</measure>
    <time_frame>One Week</time_frame>
    <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Lens Movement</measure>
    <time_frame>Baseline</time_frame>
    <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Lens Movement</measure>
    <time_frame>One Week</time_frame>
    <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Score for Vision</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Score for Vision</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Astigmatism Bilateral</condition>
  <arm_group>
    <arm_group_label>midafilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>somofilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>midafilcon A</intervention_name>
    <description>midafilcon A 1 day daily disposable contact lens</description>
    <arm_group_label>midafilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>somofilcon A</intervention_name>
    <description>somofilcon A 1 day daily disposable contact lens</description>
    <arm_group_label>somofilcon A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. They are between 18 and 40 years of age (inclusive).&#xD;
&#xD;
          2. They understand their rights as a research subject and are willing to sign a Statement&#xD;
             of Informed Consent.&#xD;
&#xD;
          3. They are willing and able to follow the protocol.&#xD;
&#xD;
          4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both&#xD;
             eyes.&#xD;
&#xD;
          5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive)&#xD;
             based on ocular refraction.&#xD;
&#xD;
          6. They own a wearable pair of spectacles and wear them on the day of the initial visit.&#xD;
&#xD;
          7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual&#xD;
             acuity in each eye with the study lenses within the available power range.&#xD;
&#xD;
          8. They are willing to comply with the wear schedule (at least five days per week and for&#xD;
             at least eight hours per day).&#xD;
&#xD;
          9. They agree not to participate in other clinical research for the duration of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. They have an ocular disorder, which would normally contra-indicate contact lens wear.&#xD;
&#xD;
          2. They have a systemic disorder, which would normally contra-indicate contact lens wear.&#xD;
&#xD;
          3. They are using any topical medication such as eye drops or ointment, or use any&#xD;
             rewetting/lubricating drops whilst on this study.&#xD;
&#xD;
          4. They are aphakic.&#xD;
&#xD;
          5. They have had corneal refractive surgery.&#xD;
&#xD;
          6. They have any corneal distortion resulting from previous hard or rigid lens wear or&#xD;
             have keratoconus.&#xD;
&#xD;
          7. They are pregnant or breastfeeding.&#xD;
&#xD;
          8. They have any ocular abnormality which would, in the opinion of the investigator,&#xD;
             normally contraindicate contact lens wear&#xD;
&#xD;
          9. They have any infectious disease which would, in the opinion of the investigator,&#xD;
             contraindicate contact lens wear or pose a risk to study personnel; or they have any&#xD;
             immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic&#xD;
             reaction.&#xD;
&#xD;
         10. They have taken part in any contact lens or care system clinical research within two&#xD;
             weeks prior to starting this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Morgan, PhD MCOptom FAAO FBCLA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eurolens Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CooperVision Inc.</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>August 25, 2020</results_first_submitted>
  <results_first_submitted_qc>September 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</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>September 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03779503/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Midafilcon A Then Somofilcon A</title>
          <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
        </group>
        <group group_id="P2">
          <title>Somofilcon A Then Midafilcon A</title>
          <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </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 were randomized to wear either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </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="55"/>
                  </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="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.3" spread="6.3"/>
                  </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="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Horizontal Centration</title>
        <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Horizontal Centration</title>
          <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Horizontal Centration</title>
        <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
        <time_frame>One Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Horizontal Centration</title>
          <description>Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)</description>
          <units>participants of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Vertical Centration</title>
        <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Vertical Centration</title>
          <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Vertical Centration</title>
        <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
        <time_frame>One Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Vertical Centration</title>
          <description>Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inferior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Superior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Corneal Coverage</title>
        <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Corneal Coverage</title>
          <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Corneal Coverage</title>
        <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
        <time_frame>One Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Corneal Coverage</title>
          <description>Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Lens Movement</title>
        <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Lens Movement</title>
          <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Lens Movement</title>
        <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
        <time_frame>One Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Lens Movement</title>
          <description>Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)</description>
          <units>percentage of lenses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly inadequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely excessive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Score for Vision</title>
        <description>Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Score for Vision</title>
          <description>Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1" spread="8.5"/>
                    <measurement group_id="O2" value="95.0" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Score for Vision</title>
        <description>Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
        <time_frame>One week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midafilcon A</title>
            <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A</title>
            <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Score for Vision</title>
          <description>Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5" spread="15.5"/>
                    <measurement group_id="O2" value="91.7" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to one week for each study lenses, a total of two weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Midafilcon A</title>
          <description>Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.&#xD;
midafilcon A: midafilcon A 1 day daily disposable contact lens</description>
        </group>
        <group group_id="E2">
          <title>Somofilcon A</title>
          <description>Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.&#xD;
somofilcon A: somofilcon A 1 day daily disposable contact lens</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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </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 A. Vega, O.D, MSc., FAAO</name_or_title>
      <organization>CooperVision. Inc</organization>
      <phone>9256213761</phone>
      <email>javega@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/NCT03779503
org study id: EX-MKTG-99 (C18-649)
nct id: NCT03779503
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study was to investigate the short-term clinical performance and subjective
      acceptance of the two study lenses.
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled
      by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week
      in random order. Lenses were worn on a daily wear, daily disposable basis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Lens Fit - Horizontal Centration
time frame: Baseline
description: Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
measure: Lens Fit - Horizontal Centration
time frame: One Week
description: Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
measure: Lens Fit - Vertical Centration
time frame: Baseline
description: Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
measure: Lens Fit - Vertical Centration
time frame: One Week
description: Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
measure: Lens Fit - Corneal Coverage
time frame: Baseline
description: Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
measure: Lens Fit - Corneal Coverage
time frame: One Week
description: Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
measure: Lens Fit - Lens Movement
time frame: Baseline
description: Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
measure: Lens Fit - Lens Movement
time frame: One Week
description: Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
measure: Subjective Score for Vision
time frame: Baseline
description: Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
measure: Subjective Score for Vision
time frame: One week
description: Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
arm group label: midafilcon A
arm group type: Active Comparator
description: Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
arm group label: somofilcon A
arm group type: Active Comparator
description: Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
intervention type: Device
intervention name: midafilcon A
description: midafilcon A 1 day daily disposable contact lens
arm group label: midafilcon A
intervention type: Device
intervention name: somofilcon A
description: somofilcon A 1 day daily disposable contact lens
arm group label: somofilcon A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Morgan, PhD MCOptom FAAO FBCLA
role: Principal Investigator
affiliation: Eurolens Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 