<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/NCT01695369</url>
  </required_header>
  <id_info>
    <org_study_id>CV-12-54</org_study_id>
    <nct_id>NCT01695369</nct_id>
  </id_info>
  <brief_title>Evaluation of Comfilcon A and Senofilcon A Lenses</brief_title>
  <official_title>Clinical Comfort Evaluation of Biofinity and Acuvue Oasys 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of Comfilcon A and Senofilcon A Lenses&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-dispensing, single-masked, randomized, contralateral study comparing the test lens&#xD;
      against the control lens. Each subject will be randomized to wear the test lens in one eye&#xD;
      and the control lens in the other eye.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Responses for Comfort Rated on a 0-100 Visual Scale.</measure>
    <time_frame>Baseline Insertion, 10 Minutes, 5 hours and 10 hours</time_frame>
    <description>Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Senofilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Senofilcon A; Comfilcon A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comfilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comfilcon A; Senofilcon A</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Senofilcon A; Comfilcon A</intervention_name>
    <description>Senofilcon A; Comfilcon A</description>
    <arm_group_label>Comfilcon A</arm_group_label>
    <arm_group_label>Senofilcon A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comfilcon A; Senofilcon A</intervention_name>
    <description>Comfilcon A; Senofilcon A</description>
    <arm_group_label>Comfilcon A</arm_group_label>
    <arm_group_label>Senofilcon A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must satisfy the following conditions prior to inclusion in the study:&#xD;
&#xD;
          -  Has had an oculo-visual examination in the last two years&#xD;
&#xD;
          -  Is at least 18 years of age and has full legal capacity to volunteer&#xD;
&#xD;
          -  Has read and understood the information consent letter&#xD;
&#xD;
          -  Is willing and able to follow instructions and maintain the appointment schedule&#xD;
&#xD;
          -  Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual&#xD;
             vision correction&#xD;
&#xD;
          -  Currently wears soft contact lenses at least 3 days a week, 8 hours a day&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease&#xD;
&#xD;
          -  Has not worn lenses for at least 12 hours before the examination&#xD;
&#xD;
          -  Have normal eyes with no evidence of abnormality or disease. For the purposes of this&#xD;
             study a normal eye is defined as one having:&#xD;
&#xD;
               -  No amblyopia&#xD;
&#xD;
               -  No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia,&#xD;
                  recurrent styes)&#xD;
&#xD;
               -  No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp&#xD;
                  findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival&#xD;
                  injection).&#xD;
&#xD;
               -  No other active ocular disease (e.g. glaucoma, history of recurrent corneal&#xD;
                  erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or&#xD;
                  inflammation of an allergic, bacterial, or viral etiology)&#xD;
&#xD;
               -  No aphakia&#xD;
&#xD;
               -  Has prescription to match the available power range.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any of the following will render a subject ineligible for inclusion:&#xD;
&#xD;
          -  Greater than 0.75 of refractive astigmatism in either eye&#xD;
&#xD;
          -  Has never worn contact lenses before&#xD;
&#xD;
          -  Wears contact lenses on an extended wear basis&#xD;
&#xD;
          -  Has any systemic disease affecting ocular health&#xD;
&#xD;
          -  Is a known sufferer of ocular allergies&#xD;
&#xD;
          -  Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and&#xD;
             ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral&#xD;
             steroids and any prescribed or over-the-counter eye medication, except artificial&#xD;
             tears or eye lubricants&#xD;
&#xD;
          -  Has any clinically significant lid or conjunctival abnormalities, neovascularization,&#xD;
             corneal scars or corneal opacities&#xD;
&#xD;
          -  Is aphakic&#xD;
&#xD;
          -  Has undergone corneal refractive surgery.&#xD;
&#xD;
          -  Is wearing monovision&#xD;
&#xD;
          -  Is participating in any other type of clinical or research study&#xD;
&#xD;
          -  Female who is currently pregnant or is breast-feeding&#xD;
&#xD;
          -  Has &gt; grade 1 ocular corneal staining in both type and extent by &gt; grade 2 in either&#xD;
             type or extent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Bergmanson, OD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston College of Optometry, TERTC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Houston College of Optometry, TERTC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>November 1, 2013</results_first_submitted>
  <results_first_submitted_qc>February 3, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 6, 2014</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">July 28, 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>Myopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Study Participants</title>
          <description>Senofilcon A and Comfilcon A</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </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>Subjects</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Study Participants</title>
          <description>Senofilcon A and Comfilcon A</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>eyes</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" spread="6"/>
                  </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="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Responses for Comfort Rated on a 0-100 Visual Scale.</title>
        <description>Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)</description>
        <time_frame>Baseline Insertion, 10 Minutes, 5 hours and 10 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Comfilcon A</title>
            <description>comfilcon A (CooperVision Biofinity®Sphere)</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A</title>
            <description>Senofilcon A (Vistakon Acuvue® Oasys)</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Responses for Comfort Rated on a 0-100 Visual Scale.</title>
          <description>Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 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="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" spread="15"/>
                    <measurement group_id="O2" value="87" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="14"/>
                    <measurement group_id="O2" value="91" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" spread="19"/>
                    <measurement group_id="O2" value="84" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" spread="23"/>
                    <measurement group_id="O2" value="81" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Overall Study Participants</title>
          <description>Senofilcon A and Comfilcon A</description>
        </group>
        <group group_id="E2">
          <title>Comfilcon A</title>
          <description>Comfilcon A / CooperVision Biofinity Sphere</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jan Bergmanson, OD,PhD</name_or_title>
      <organization>University of Houston, College of Optometry, TERTC</organization>
      <phone>713-743-1950</phone>
      <email>jbergmanson@uh.edu</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/NCT01695369
org study id: CV-12-54
nct id: NCT01695369
lead sponsor: 
has dmc: No
Evaluation of Comfilcon A and Senofilcon A Lenses
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens
      against the control lens. Each subject will be randomized to wear the test lens in one eye
      and the control lens in the other eye.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
description: Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
arm group label: Senofilcon A
arm group type: Active Comparator
description: Senofilcon A; Comfilcon A
arm group label: Comfilcon A
arm group type: Experimental
description: Comfilcon A; Senofilcon A
intervention type: Device
intervention name: Senofilcon A; Comfilcon A
description: Senofilcon A; Comfilcon A
arm group label: Comfilcon A
arm group label: Senofilcon A
intervention type: Device
intervention name: Comfilcon A; Senofilcon A
description: Comfilcon A; Senofilcon A
arm group label: Comfilcon A
arm group label: Senofilcon A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Bergmanson, OD, PhD
role: Principal Investigator
affiliation: University of Houston College of Optometry, TERTC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 