<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/NCT02248766</url>
  </required_header>
  <id_info>
    <org_study_id>EX-MKTG-53</org_study_id>
    <nct_id>NCT02248766</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses</brief_title>
  <official_title>Clinical Performance of Habitual Wearers of Avaira Toric (Enfilcon A) When Refitted With Clariti Toric (Somofilcon A) Lenses for 1 Month.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this dispensing study is to evaluate the clinical performance of existing wearers&#xD;
      of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 30-subject, prospective dispensing study comparing the clinical performance of the&#xD;
      subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's&#xD;
      habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a&#xD;
      pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects&#xD;
      will return for evaluations at 1 week, 2 weeks and 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity - Enfilcon A and Somofilcon A</measure>
    <time_frame>Baseline, 1 week, 2 week, 4 week</time_frame>
    <description>Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Assessments- Enfilcon A and Somofilcon A</measure>
    <time_frame>Baseline, 1 week, 2 week, 4 week</time_frame>
    <description>Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>enfilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>somofilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>somofilcon A</intervention_name>
    <description>somofilcon A lens</description>
    <arm_group_label>enfilcon A</arm_group_label>
    <arm_group_label>somofilcon A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is between 18 and 40 years of age (inclusive)&#xD;
&#xD;
          -  Has had a self-reported visual exam in the last two years&#xD;
&#xD;
          -  Is an adapted Avaira toric contact lens (CL) wearer (at least 1 week of wear in Avaira&#xD;
             toric)&#xD;
&#xD;
          -  Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)&#xD;
&#xD;
          -  Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes.&#xD;
&#xD;
          -  Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or&#xD;
             better in each eye.&#xD;
&#xD;
          -  Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with&#xD;
             the study contact lenses.&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Has read, understood and signed the information consent letter.&#xD;
&#xD;
          -  Patient contact lens refraction should fit within the available parameters of the&#xD;
             study lenses.&#xD;
&#xD;
          -  Is willing to comply with the wear schedule (at least 5 days per week, &gt; 8 hours/day&#xD;
             assuming there are no contraindications for doing so).&#xD;
&#xD;
          -  Is willing to comply with the visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is not a habitual wearer of Avaira toric lenses&#xD;
&#xD;
          -  Has a CL prescription outside the range of the available parameters of the study&#xD;
             lenses.&#xD;
&#xD;
          -  Has a spectacle cylinder less than -0.75D or more than -1.75 D of cylinder in either&#xD;
             eye.&#xD;
&#xD;
          -  Has a history of not achieving comfortable CL wear (5 days per week; &gt; 8 hours/day)&#xD;
&#xD;
          -  Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in&#xD;
             either eye.&#xD;
&#xD;
          -  Presence of clinically significant (grade 2-4) anterior segment abnormalities&#xD;
&#xD;
          -  Presence of ocular or systemic disease or need of medications which might interfere&#xD;
             with contact lens wear.&#xD;
&#xD;
          -  Slit lamp findings that would contraindicate contact lens wear such as:&#xD;
&#xD;
               -  Pathological dry eye or associated findings&#xD;
&#xD;
               -  Pterygium, pinguecula, or corneal scars within the visual axis&#xD;
&#xD;
               -  Neovascularization &gt; 0.75 mm in from of the limbus&#xD;
&#xD;
               -  Giant papillary conjunctivitis (GCP) worse than grade 1&#xD;
&#xD;
               -  Anterior uveitis or iritis (past or present)&#xD;
&#xD;
               -  Seborrheic eczema, Seborrheic conjunctivitis&#xD;
&#xD;
               -  History of corneal ulcers or fungal infections&#xD;
&#xD;
               -  Poor personal hygiene&#xD;
&#xD;
          -  Has a known history of corneal hypoesthesia (reduced corneal sensitivity)&#xD;
&#xD;
          -  Has aphakia, keratoconus or a highly irregular cornea.&#xD;
&#xD;
          -  Has Presbyopia or has dependence on spectacles for near work over the contact lenses.&#xD;
&#xD;
          -  Has undergone corneal refractive surgery.&#xD;
&#xD;
          -  Is participating in any other type of eye related clinical or research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Montés-Mico, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Optometry Research Group (GIO)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Optometry Research Group (GIO) - Optics Department, University of Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>February 23, 2016</results_first_submitted>
  <results_first_submitted_qc>February 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 23, 2016</results_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enfilcon A / Somofilcon A</title>
          <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens&#xD;
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This study had a total of 30 participants. The 30 participants were evaluated with the habitual lenses (enfilcon A) and then evaluated with the (somofilcon A) lenses.</population>
      <group_list>
        <group group_id="B1">
          <title>Enfilcon A / Somofilcon A</title>
          <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens&#xD;
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity - Enfilcon A and Somofilcon A</title>
        <description>Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.</description>
        <time_frame>Baseline, 1 week, 2 week, 4 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enfilcon A</title>
            <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A at 1 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
          <group group_id="O3">
            <title>Somofilcon A at 2 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
          <group group_id="O4">
            <title>Somofilcon A at 4 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity - Enfilcon A and Somofilcon A</title>
          <description>Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.</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="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Oculus Dexter (OD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.013" spread="0.03"/>
                    <measurement group_id="O2" value="-0.013" spread="0.03"/>
                    <measurement group_id="O3" value="-0.010" spread="0.03"/>
                    <measurement group_id="O4" value="-0.023" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oculus Sinister (OS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.03"/>
                    <measurement group_id="O2" value="-0.010" spread="0.03"/>
                    <measurement group_id="O3" value="-0.017" spread="0.03"/>
                    <measurement group_id="O4" value="-0.017" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Binocular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.033" spread="0.05"/>
                    <measurement group_id="O2" value="-0.033" spread="0.05"/>
                    <measurement group_id="O3" value="-0.040" spread="0.05"/>
                    <measurement group_id="O4" value="-0.040" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Assessments- Enfilcon A and Somofilcon A</title>
        <description>Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)</description>
        <time_frame>Baseline, 1 week, 2 week, 4 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enfilcon A</title>
            <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
          </group>
          <group group_id="O2">
            <title>Somofilcon A at 1 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
          <group group_id="O3">
            <title>Somofilcon A at 2 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
          <group group_id="O4">
            <title>Somofilcon A at 4 Week</title>
            <description>All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Assessments- Enfilcon A and Somofilcon A</title>
          <description>Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very 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="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Comfort on insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.53" spread="1.00"/>
                    <measurement group_id="O2" value="8.43" spread="0.62"/>
                    <measurement group_id="O3" value="8.07" spread="0.64"/>
                    <measurement group_id="O4" value="7.50" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comfort prior to removal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.13" spread="0.94"/>
                    <measurement group_id="O2" value="7.83" spread="0.80"/>
                    <measurement group_id="O3" value="7.20" spread="0.71"/>
                    <measurement group_id="O4" value="6.70" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comfort overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.10" spread="0.92"/>
                    <measurement group_id="O2" value="7.63" spread="0.77"/>
                    <measurement group_id="O3" value="7.10" spread="0.76"/>
                    <measurement group_id="O4" value="6.20" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness during the day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.47" spread="0.73"/>
                    <measurement group_id="O2" value="8.27" spread="0.64"/>
                    <measurement group_id="O3" value="7.63" spread="0.88"/>
                    <measurement group_id="O4" value="7.43" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness prior to removal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.23" spread="0.73"/>
                    <measurement group_id="O2" value="8.00" spread="0.79"/>
                    <measurement group_id="O3" value="7.33" spread="0.80"/>
                    <measurement group_id="O4" value="7.03" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.03" spread="0.67"/>
                    <measurement group_id="O2" value="7.77" spread="0.73"/>
                    <measurement group_id="O3" value="7.13" spread="0.86"/>
                    <measurement group_id="O4" value="6.70" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Handling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.23" spread="0.63"/>
                    <measurement group_id="O2" value="9.20" spread="0.55"/>
                    <measurement group_id="O3" value="9.17" spread="0.46"/>
                    <measurement group_id="O4" value="9.00" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall lens fit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.93" spread="0.69"/>
                    <measurement group_id="O2" value="7.90" spread="0.78"/>
                    <measurement group_id="O3" value="7.77" spread="0.76"/>
                    <measurement group_id="O4" value="8.13" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall vision satisfaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.30" spread="0.79"/>
                    <measurement group_id="O2" value="8.10" spread="0.69"/>
                    <measurement group_id="O3" value="7.60" spread="0.67"/>
                    <measurement group_id="O4" value="7.77" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Enfilcon A</title>
          <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
        </group>
        <group group_id="E2">
          <title>Somofilcon A</title>
          <description>All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens&#xD;
somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Principal Investigators are NOT employed by the organization sponsoring the study.&#xD;
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.&#xD;
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Robert Montes-Mico, O.D., PhD</name_or_title>
      <organization>Optometry Research Group (GIO) University of Valencia</organization>
      <phone>34-9635-44764</phone>
      <email>robert.montes@uv.es</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/NCT02248766
org study id: EX-MKTG-53
nct id: NCT02248766
lead sponsor: 
has dmc: No
The aim of this dispensing study is to evaluate the clinical performance of existing wearers
      of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
This is a 30-subject, prospective dispensing study comparing the clinical performance of the
      subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's
      habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a
      pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects
      will return for evaluations at 1 week, 2 weeks and 4 weeks.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
measure: Visual Acuity - Enfilcon A and Somofilcon A
time frame: Baseline, 1 week, 2 week, 4 week
description: Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
measure: Subjective Assessments- Enfilcon A and Somofilcon A
time frame: Baseline, 1 week, 2 week, 4 week
description: Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)
arm group label: enfilcon A
arm group type: Active Comparator
description: All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens
arm group label: somofilcon A
arm group type: Experimental
description: All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens
intervention type: Device
intervention name: somofilcon A
description: somofilcon A lens
arm group label: enfilcon A
arm group label: somofilcon A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Robert Montés-Mico, OD
role: Principal Investigator
affiliation: Optometry Research Group (GIO)
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Astigmatism
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 