<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/NCT03006458</url>
  </required_header>
  <id_info>
    <org_study_id>CV-16-28 (C16-599)</org_study_id>
    <nct_id>NCT03006458</nct_id>
  </id_info>
  <brief_title>A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses</brief_title>
  <official_title>A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the clinical performance and subjective acceptance of the&#xD;
      comfilcon A and the omafilcon B soft contact lenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross&#xD;
      comparison. Thirty subjects will use each lens type for two weeks in random sequence.&#xD;
      Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn&#xD;
      on a daily wear basis.&#xD;
&#xD;
      The final optical design of comfilcon A contact lens was optimized to improve the quality and&#xD;
      two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to&#xD;
      evaluate the modified optical design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 6, 2017</completion_date>
  <primary_completion_date type="Actual">April 6, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stability</measure>
    <time_frame>Baseline</time_frame>
    <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stability</measure>
    <time_frame>2 weeks</time_frame>
    <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Toric Lens Fit Acceptance</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Toric Lens Fit Acceptance</measure>
    <time_frame>2 weeks</time_frame>
    <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comfort</measure>
    <time_frame>Baseline</time_frame>
    <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comfort</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Satisfaction</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dryness</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Fluctuation/ Stability</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Handling</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Near Vision</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Intermediate Vision</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Distance Vision</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Vision While Driving During the Day</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Vision While Driving During the Night</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ghosting at Near</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ghosting at Distance</measure>
    <time_frame>2 weeks</time_frame>
    <description>Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>comfilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>omafilcon B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comfilcon A</intervention_name>
    <description>toric contact lens</description>
    <arm_group_label>comfilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>omafilcon B</intervention_name>
    <description>toric contact lens</description>
    <arm_group_label>omafilcon B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will only be eligible for the study if:&#xD;
&#xD;
               1. They are aged 40 - 70 years, inclusive.&#xD;
&#xD;
               2. They understand their rights as a research subject and are willing and able to&#xD;
                  sign a Statement of Informed Consent.&#xD;
&#xD;
               3. They are willing and able to follow the protocol.&#xD;
&#xD;
               4. They have successfully completed the non-dispensing study (C16-597) as the lenses&#xD;
                  to be worn on this study (C16-599) are predetermined from their participation on&#xD;
                  study C16-597.&#xD;
&#xD;
               5. They have a contact lens spherical prescription between +10.00 to -10.00D&#xD;
                  (Diopters) (inclusive).&#xD;
&#xD;
               6. They have astigmatism between of -0.75 and -5.75DC (based on the calculated&#xD;
                  ocular refraction) in each eye.&#xD;
&#xD;
               7. They have an Add component to their spectacle refraction (between +0.75 and&#xD;
&#xD;
                  +2.50DS).&#xD;
&#xD;
               8. They can be satisfactorily fitted with the study lenses.&#xD;
&#xD;
               9. They can attain at least 0.30 logMAR binocular distance high contrast visual&#xD;
                  acuity with the study lenses within the available power range.&#xD;
&#xD;
              10. They have successfully worn soft contact lenses in the last two years.&#xD;
&#xD;
              11. They are willing to comply with the wear schedule (at least five days per week&#xD;
                  and for at least six hours per day).&#xD;
&#xD;
              12. They agree not to participate in other clinical research for the duration of this&#xD;
                  study.&#xD;
&#xD;
              13. They own a wearable pair of spectacles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will not be eligible to take part in the study if:&#xD;
&#xD;
               1. They have an ocular disorder which would normally contra-indicate contact lens&#xD;
                  wear.&#xD;
&#xD;
               2. They have a systemic disorder which would normally contra-indicate contact lens&#xD;
                  wear.&#xD;
&#xD;
               3. They are using any topical medication such as eye drops or ointment.&#xD;
&#xD;
               4. They have had cataract surgery.&#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&#xD;
                  or have keratoconus.&#xD;
&#xD;
               7. They are pregnant or breast-feeding.&#xD;
&#xD;
               8. They have any clinically meaningful slit lamp findings contraindicating contact&#xD;
                  lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal&#xD;
                  staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian&#xD;
                  gland dysfunction) on the Efron classification scale or any other ocular&#xD;
                  abnormality that in the opinion of the investigator would contraindicate contact&#xD;
                  lens wear.&#xD;
&#xD;
               9. They have any infectious disease (e.g. hepatitis) which would, in the opinion of&#xD;
                  the investigator, contraindicate contact lens wear or pose a risk to study&#xD;
                  personnel; or they have any immunosuppressive disease (e.g. HIV).&#xD;
&#xD;
              10. They have a history of anaphylaxis or severe allergic reaction.&#xD;
&#xD;
              11. 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>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eurolens Research</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>May 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <results_first_submitted>April 29, 2020</results_first_submitted>
  <results_first_submitted_qc>May 15, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2020</results_first_posted>
  <disposition_first_submitted>December 19, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>December 19, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 24, 2019</disposition_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 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>
  <patient_data>
    <sharing_ipd>Undecided</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>June 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03006458/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Comfilcon A Then Omafilcon B</title>
          <description>Participants were randomized to wear comfilcon A for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
        </group>
        <group group_id="P2">
          <title>Omafilcon B Then Comfilcon A</title>
          <description>Participants were randomized to wear omafilcon B for two weeks during the cross over study.&#xD;
omafilcon B: toric 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="14"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unsatisfied Vision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </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="14"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="10"/>
              </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>Total Participants</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </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="24"/>
                  </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="24"/>
                  </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="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.2" spread="6.2"/>
                  </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="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </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 Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stability</title>
        <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Stability</title>
          <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.5"/>
                    <measurement group_id="O2" value="2.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Stability</title>
        <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Stability</title>
          <description>Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.7"/>
                    <measurement group_id="O2" value="2.5" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Toric Lens Fit Acceptance</title>
        <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Toric Lens Fit Acceptance</title>
          <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="0.5"/>
                    <measurement group_id="O2" value="3.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Toric Lens Fit Acceptance</title>
        <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Toric Lens Fit Acceptance</title>
          <description>Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="0.6"/>
                    <measurement group_id="O2" value="2.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comfort</title>
        <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort</title>
          <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6" spread="20.3"/>
                    <measurement group_id="O2" value="79.7" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comfort</title>
        <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort</title>
          <description>Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" spread="21.8"/>
                    <measurement group_id="O2" value="70.6" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Satisfaction</title>
        <description>Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Satisfaction</title>
          <description>Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0" spread="31.4"/>
                    <measurement group_id="O2" value="63.3" spread="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dryness</title>
        <description>Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Dryness</title>
          <description>Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.4" spread="24.7"/>
                    <measurement group_id="O2" value="77.2" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Fluctuation/ Stability</title>
        <description>Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Fluctuation/ Stability</title>
          <description>Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.0" spread="16.1"/>
                    <measurement group_id="O2" value="73.8" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Handling</title>
        <description>Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Handling</title>
          <description>Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.5" spread="15.0"/>
                    <measurement group_id="O2" value="85.8" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Near Vision</title>
        <description>Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Near Vision</title>
          <description>Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5" spread="30.5"/>
                    <measurement group_id="O2" value="56.4" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Intermediate Vision</title>
        <description>Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Intermediate Vision</title>
          <description>Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.2" spread="29.5"/>
                    <measurement group_id="O2" value="65.3" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Distance Vision</title>
        <description>Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Distance Vision</title>
          <description>Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" spread="13.7"/>
                    <measurement group_id="O2" value="67.3" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Vision While Driving During the Day</title>
        <description>Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Vision While Driving During the Day</title>
          <description>Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</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="20"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3" spread="14.6"/>
                    <measurement group_id="O2" value="76.2" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Vision While Driving During the Night</title>
        <description>Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Vision While Driving During the Night</title>
          <description>Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.</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="20"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0" spread="18.6"/>
                    <measurement group_id="O2" value="67.0" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ghosting at Near</title>
        <description>Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Ghosting at Near</title>
          <description>Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</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="23"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.5" spread="35.0"/>
                    <measurement group_id="O2" value="78.1" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ghosting at Distance</title>
        <description>Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
          </group>
          <group group_id="O2">
            <title>Omafilcon B</title>
            <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric contact lens</description>
          </group>
        </group_list>
        <measure>
          <title>Ghosting at Distance</title>
          <description>Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.</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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" spread="24.8"/>
                    <measurement group_id="O2" value="86.9" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline to follow up visit for an average of 2 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comfilcon A</title>
          <description>Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.&#xD;
comfilcon A: toric contact lens</description>
        </group>
        <group group_id="E2">
          <title>Omafilcon B</title>
          <description>Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.&#xD;
omafilcon B: toric 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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </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>Myhanh Nguyen</name_or_title>
      <organization>CooperVision</organization>
      <phone>9257306716</phone>
      <email>MNguyen@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/NCT03006458
org study id: CV-16-28 (C16-599)
nct id: NCT03006458
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 clinical performance and subjective acceptance of the
      comfilcon A and the omafilcon B soft contact lenses.
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross
      comparison. Thirty subjects will use each lens type for two weeks in random sequence.
      Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn
      on a daily wear basis.

      The final optical design of comfilcon A contact lens was optimized to improve the quality and
      two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to
      evaluate the modified optical design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Stability
time frame: Baseline
description: Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
measure: Stability
time frame: 2 weeks
description: Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
measure: Overall Toric Lens Fit Acceptance
time frame: Baseline
description: Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
measure: Overall Toric Lens Fit Acceptance
time frame: 2 weeks
description: Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
measure: Comfort
time frame: Baseline
description: Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
measure: Comfort
time frame: 2 weeks
description: Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
measure: Overall Satisfaction
time frame: 2 weeks
description: Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
measure: Dryness
time frame: 2 weeks
description: Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
measure: Visual Fluctuation/ Stability
time frame: 2 weeks
description: Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
measure: Handling
time frame: 2 weeks
description: Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy
measure: Quality of Near Vision
time frame: 2 weeks
description: Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
measure: Quality of Intermediate Vision
time frame: 2 weeks
description: Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
measure: Quality of Distance Vision
time frame: 2 weeks
description: Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
measure: Quality of Vision While Driving During the Day
time frame: 2 weeks
description: Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
measure: Quality of Vision While Driving During the Night
time frame: 2 weeks
description: Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
measure: Ghosting at Near
time frame: 2 weeks
description: Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
measure: Ghosting at Distance
time frame: 2 weeks
description: Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
arm group label: comfilcon A
arm group type: Experimental
description: Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.
arm group label: omafilcon B
arm group type: Active Comparator
description: Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.
intervention type: Device
intervention name: comfilcon A
description: toric contact lens
arm group label: comfilcon A
intervention type: Device
intervention name: omafilcon B
description: toric contact lens
arm group label: omafilcon B
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Astigmatism
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 