<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/NCT03235115</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-85</org_study_id>
    <nct_id>NCT03235115</nct_id>
  </id_info>
  <brief_title>Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses</brief_title>
  <official_title>Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical 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>
      This study aims to compare the short-term clinical performance of the three contact lenses&#xD;
      (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized, double-masked, crossover, bilateral non-dispensing study,&#xD;
      controlled by cross-comparison. Forty subjects will wear each lens brand for approximately&#xD;
      one hour, on three separate study days in random order. Lenses will only be worn during study&#xD;
      visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2017</start_date>
  <completion_date type="Actual">September 22, 2017</completion_date>
  <primary_completion_date type="Actual">September 22, 2017</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>Visual Acuity Using logMAR</measure>
    <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
    <description>Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Horizontal Centration</measure>
    <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
    <description>Assessment of horizontal centration of lens on eye</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Vertical Centration</measure>
    <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
    <description>Assessment of vertical centration of lens on eye</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Corneal Coverage of Lens</measure>
    <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
    <description>Assessment of corneal coverage of lens on eye</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit - Movement of Lens</measure>
    <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
    <description>Assessment of movement of lens on eye</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Methafilcon A IV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ocufilcon B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omafilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Methafilcon A IV</intervention_name>
    <description>Contact Lens</description>
    <arm_group_label>Ocufilcon B</arm_group_label>
    <arm_group_label>Omafilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ocufilcon B</intervention_name>
    <description>Contact Lens</description>
    <arm_group_label>Methafilcon A IV</arm_group_label>
    <arm_group_label>Omafilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Omafilcon A</intervention_name>
    <description>Contact Lens</description>
    <arm_group_label>Methafilcon A IV</arm_group_label>
    <arm_group_label>Ocufilcon B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  They are of aged 18-40 and have capacity to volunteer.&#xD;
&#xD;
          -  They understand their rights as a research subject and are willing and able to sign a&#xD;
             Statement of Informed Consent.&#xD;
&#xD;
          -  They are willing and able to follow the protocol.&#xD;
&#xD;
          -  They agree not to participate in other clinical research for the duration of this&#xD;
             study.&#xD;
&#xD;
          -  They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)&#xD;
&#xD;
          -  They have a spectacle cylindrical correction of -0.75D or less in each eye (based on&#xD;
             the ocular refraction).&#xD;
&#xD;
          -  They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye&#xD;
             with the study lenses within the available power range.&#xD;
&#xD;
          -  They currently use soft contact lenses or have done so in the previous six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They have an ocular disorder which would normally contra-indicate contact lens wear.&#xD;
&#xD;
          -  They have a systemic disorder which would normally contra-indicate contact lens wear.&#xD;
&#xD;
          -  They are using any topical medication such as eye drops or ointment.&#xD;
&#xD;
          -  They have had cataract surgery.&#xD;
&#xD;
          -  They have had corneal refractive surgery.&#xD;
&#xD;
          -  They have any corneal distortion resulting from previous hard or rigid lens wear or&#xD;
             have keratoconus.&#xD;
&#xD;
          -  They are pregnant or lactating.&#xD;
&#xD;
          -  They have any ocular abnormality which would, in the opinion of the investigator,&#xD;
             normally contraindicate contact lens wear.&#xD;
&#xD;
          -  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;
          -  They have taken part in any other contact lens or care solution clinical trial or&#xD;
             research, within two 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>
  <location>
    <facility>
      <name>Eurolens Research - The University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>October 15, 2018</results_first_submitted>
  <results_first_submitted_qc>October 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2018</results_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</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>Seizures</mesh_term>
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol 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>May 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03235115/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Methafilcon A IV, Ocufilcon B, Omafilcon A</title>
          <description>Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens</description>
        </group>
        <group group_id="P2">
          <title>Methafilcon A IV, Omafilcon A, Ocufilcon B</title>
          <description>Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens</description>
        </group>
        <group group_id="P3">
          <title>Ocufilcon B, Omafilcon A, Methafilcon A IV</title>
          <description>Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens</description>
        </group>
        <group group_id="P4">
          <title>Ocufilcon B, Methafilcon A IV, Omafilcon A</title>
          <description>Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens</description>
        </group>
        <group group_id="P5">
          <title>Omafilcon A, Ocufilcon B, Methafilcon A IV</title>
          <description>Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens</description>
        </group>
        <group group_id="P6">
          <title>Omafilcon A, Methafilcon A IV, Ocufilcon B</title>
          <description>Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (1 Hour, Visit 2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second Intervention (1 Hour, Visit 4)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention ( 1 Hour, Visit 6)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>All study participants were randomized to wear each of the 3 different contact lens pairs</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.0" spread="6.4"/>
                  </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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity Using logMAR</title>
        <description>Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction</description>
        <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omafilcon A</title>
            <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
          </group>
          <group group_id="O2">
            <title>Methafilcon A IV</title>
            <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
          <group group_id="O3">
            <title>Ocufilcon B</title>
            <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity Using logMAR</title>
          <description>Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction</description>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Dispense</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.09"/>
                    <measurement group_id="O2" value="-0.13" spread="0.07"/>
                    <measurement group_id="O3" value="-0.13" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.07"/>
                    <measurement group_id="O2" value="-0.14" spread="0.07"/>
                    <measurement group_id="O3" value="-0.14" spread="0.07"/>
                  </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 on eye</description>
        <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omafilcon A</title>
            <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
          </group>
          <group group_id="O2">
            <title>Methafilcon A IV</title>
            <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
          <group group_id="O3">
            <title>Ocufilcon B</title>
            <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Horizontal Centration</title>
          <description>Assessment of horizontal centration of lens on eye</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At dispense</title>
              <category_list>
                <category>
                  <title>Extremely nasal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly nasal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly temporal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely temporal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At follow up</title>
              <category_list>
                <category>
                  <title>Extremely nasal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly nasal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly temporal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely temporal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" 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 on eye</description>
        <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omafilcon A</title>
            <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
          </group>
          <group group_id="O2">
            <title>Methafilcon A IV</title>
            <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
          <group group_id="O3">
            <title>Ocufilcon B</title>
            <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Vertical Centration</title>
          <description>Assessment of vertical centration of lens on eye</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At dispense</title>
              <category_list>
                <category>
                  <title>Extremely inferior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inferior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly superior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely superior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At follow up</title>
              <category_list>
                <category>
                  <title>Extremely inferior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inferior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly superior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely superior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Corneal Coverage of Lens</title>
        <description>Assessment of corneal coverage of lens on eye</description>
        <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omafilcon A</title>
            <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
          </group>
          <group group_id="O2">
            <title>Methafilcon A IV</title>
            <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
          <group group_id="O3">
            <title>Ocufilcon B</title>
            <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Corneal Coverage of Lens</title>
          <description>Assessment of corneal coverage of lens on eye</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At dispense</title>
              <category_list>
                <category>
                  <title>Extremely inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At follow up</title>
              <category_list>
                <category>
                  <title>Extremely inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit - Movement of Lens</title>
        <description>Assessment of movement of lens on eye</description>
        <time_frame>Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omafilcon A</title>
            <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
          </group>
          <group group_id="O2">
            <title>Methafilcon A IV</title>
            <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
          <group group_id="O3">
            <title>Ocufilcon B</title>
            <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit - Movement of Lens</title>
          <description>Assessment of movement of lens on eye</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At dispense</title>
              <category_list>
                <category>
                  <title>Extremely inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At follow up</title>
              <category_list>
                <category>
                  <title>Extremely inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly inadequate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Optimum</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely excessive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients wore 3 different contact lenses for 1 hour on 3 different days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Omafilcon A</title>
          <description>Subjects who wore Omafilcon A for 1 hour during the cross over study.</description>
        </group>
        <group group_id="E2">
          <title>Methafilcon A IV</title>
          <description>Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.</description>
        </group>
        <group group_id="E3">
          <title>Ocufilcon B</title>
          <description>Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
              </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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
              </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>Disclosure restriction on the PI is that the sponsor should be notified of any use of data for results communication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jose Vega, O.D., MSc., FAAO</name_or_title>
      <organization>CooperVision</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/NCT03235115
org study id: EX-MKTG-85
nct id: NCT03235115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to compare the short-term clinical performance of the three contact lenses
      (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).
This will be a randomized, double-masked, crossover, bilateral non-dispensing study,
      controlled by cross-comparison. Forty subjects will wear each lens brand for approximately
      one hour, on three separate study days in random order. Lenses will only be worn during study
      visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Acuity Using logMAR
time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
description: Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
measure: Lens Fit - Horizontal Centration
time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
description: Assessment of horizontal centration of lens on eye
measure: Lens Fit - Vertical Centration
time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
description: Assessment of vertical centration of lens on eye
measure: Lens Fit - Corneal Coverage of Lens
time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
description: Assessment of corneal coverage of lens on eye
measure: Lens Fit - Movement of Lens
time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
description: Assessment of movement of lens on eye
arm group label: Methafilcon A IV
arm group type: Active Comparator
description: Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.
arm group label: Ocufilcon B
arm group type: Active Comparator
description: Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.
arm group label: Omafilcon A
arm group type: Active Comparator
description: Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.
intervention type: Device
intervention name: Methafilcon A IV
description: Contact Lens
arm group label: Ocufilcon B
arm group label: Omafilcon A
intervention type: Device
intervention name: Ocufilcon B
description: Contact Lens
arm group label: Methafilcon A IV
arm group label: Omafilcon A
intervention type: Device
intervention name: Omafilcon A
description: Contact Lens
arm group label: Methafilcon A IV
arm group label: Ocufilcon B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Seizures
mesh term: Myopia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 