<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/NCT01699750</url>
  </required_header>
  <id_info>
    <org_study_id>M-12-043 / ID11-59</org_study_id>
    <nct_id>NCT01699750</nct_id>
  </id_info>
  <brief_title>Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems</brief_title>
  <official_title>Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and&#xD;
      visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when&#xD;
      used in conjunction with two contact lens care systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1),&#xD;
      participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for&#xD;
      contact lens care. Eligible participants will continue into the Investigational Phase (Phase&#xD;
      2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with&#xD;
      HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants&#xD;
      will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Ex-Vivo Total Lipid Uptake Per Lens</measure>
    <time_frame>Day 30</time_frame>
    <description>The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)</measure>
    <time_frame>Day 30</time_frame>
    <description>The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LogMAR Time-Controlled Visual Acuity (TCVA)</measure>
    <time_frame>Day 30</time_frame>
    <description>Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Comfort Measured With Visual Analog Scale (VAS)</measure>
    <time_frame>Day 30</time_frame>
    <description>The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Dryness Measured With Visual Analog Scale (VAS)</measure>
    <time_frame>Day 30</time_frame>
    <description>The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Exposure Speed</measure>
    <time_frame>Day 30</time_frame>
    <description>Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Protected Area</measure>
    <time_frame>Day 30</time_frame>
    <description>Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Myopia</condition>
  <condition>Astigmatism</condition>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>Air Optix Aqua</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotrafilcon B contact lenses</intervention_name>
    <description>Silicone hydrogel contact lenses, Phase 2</description>
    <arm_group_label>Air Optix Aqua</arm_group_label>
    <other_name>AIR OPTIX® AQUA</other_name>
    <other_name>AOA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Senofilcon A contact lenses</intervention_name>
    <description>Silicone hydrogel contact lenses, Phase 2</description>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <other_name>ACUVUE® OASYS® with HYDRACLEAR®</other_name>
    <other_name>AVO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OPTI-FREE® PUREMOIST® MPDS</intervention_name>
    <description>Contact lens care system, Phase 2</description>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <arm_group_label>Air Optix Aqua</arm_group_label>
    <other_name>OFPM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BIOTRUE®</intervention_name>
    <description>Contact lens care system, Phase 2</description>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <arm_group_label>Air Optix Aqua</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balafilcon A contact lenses</intervention_name>
    <description>Silicone hydrogel contact lenses worn for 30 days, Phase 1</description>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <arm_group_label>Air Optix Aqua</arm_group_label>
    <other_name>PureVision</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReNu® Multiplus®</intervention_name>
    <description>Contact lens care system used for 30 days, Phase 1</description>
    <arm_group_label>Acuvue Oasys</arm_group_label>
    <arm_group_label>Air Optix Aqua</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Read and understand the Participant Information Sheet;&#xD;
&#xD;
          -  Read, sign, and date the Informed Consent;&#xD;
&#xD;
          -  Be a current silicone hydrogel contact lens wearer using the contact lenses under a&#xD;
             frequent replacement (bi-weekly or monthly) daily wear modality;&#xD;
&#xD;
          -  Be classified as symptomatic and a depositor at the end of the replacement period&#xD;
             according to protocol-specified criteria;&#xD;
&#xD;
          -  Agree to wear study contact lenses as directed for the duration of the study and&#xD;
             maintain the appointment schedule;&#xD;
&#xD;
          -  Best corrected visual acuity of 6/9 or better in each eye;&#xD;
&#xD;
          -  Normal eyes with the exception of the need for visual correction;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity or intolerance to any of the contact lenses or contact lens care&#xD;
             products to be used;&#xD;
&#xD;
          -  Monocular vision (only one eye with functional vision or only one eye fitted with&#xD;
             contact lenses);&#xD;
&#xD;
          -  Use of systemic medication which might interfere with contact lens wear or produce dry&#xD;
             eye side effects;&#xD;
&#xD;
          -  Systemic disease which might interfere with contact lens wear or produce dry eye side&#xD;
             effects;&#xD;
&#xD;
          -  Systemic or ocular allergies which might interfere with contact lens wear;&#xD;
&#xD;
          -  Ocular disease which might interfere with contact lens wear;&#xD;
&#xD;
          -  Active ocular infection;&#xD;
&#xD;
          -  Use of any concomitant topical ocular medications during the study period;&#xD;
&#xD;
          -  Previous ocular surgery;&#xD;
&#xD;
          -  Pregnant, planning to become pregnant, or lactating at the time of enrollment;&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 30 days of entering&#xD;
             this study;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#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>Jami Kern, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Contact Alcon Call Center at 1-888-451-3937 for Trial Locations</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>December 1, 2014</results_first_submitted>
  <results_first_submitted_qc>December 3, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 8, 2014</results_first_posted>
  <last_update_submitted>December 3, 2014</last_update_submitted>
  <last_update_submitted_qc>December 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contact lenses</keyword>
  <keyword>contact lens solution</keyword>
  <keyword>myopia</keyword>
  <keyword>astigmatism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Astigmatism</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 study center located in the United Kingdom.</recruitment_details>
      <pre_assignment_details>Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Air Optix Aqua</title>
          <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
        </group>
        <group group_id="P2">
          <title>Acuvue Oasys</title>
          <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
              </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>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all randomized and dispensed participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Air Optix Aqua</title>
          <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
        </group>
        <group group_id="B2">
          <title>Acuvue Oasys</title>
          <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="70"/>
          </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="36.0" spread="10.95"/>
                    <measurement group_id="B2" value="35.3" spread="8.77"/>
                    <measurement group_id="B3" value="35.6" spread="9.82"/>
                  </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="24"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Ex-Vivo Total Lipid Uptake Per Lens</title>
        <description>The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Air Optix Aqua</title>
            <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
          <group group_id="O2">
            <title>Acuvue Oasys</title>
            <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Ex-Vivo Total Lipid Uptake Per Lens</title>
          <description>The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
          <units>micrograms</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.198" spread="1.5014"/>
                    <measurement group_id="O2" value="35.879" spread="1.8185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)</title>
        <description>The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Air Optix Aqua</title>
            <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
          <group group_id="O2">
            <title>Acuvue Oasys</title>
            <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)</title>
          <description>The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
          <units>seconds</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.316" spread="2.6913"/>
                    <measurement group_id="O2" value="2.918" spread="2.4859"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LogMAR Time-Controlled Visual Acuity (TCVA)</title>
        <description>Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Air Optix Aqua</title>
            <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
          <group group_id="O2">
            <title>Acuvue Oasys</title>
            <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
        </group_list>
        <measure>
          <title>LogMAR Time-Controlled Visual Acuity (TCVA)</title>
          <description>Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.</population>
          <units>VA unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>High Contrast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="1.058"/>
                    <measurement group_id="O2" value="-0.14" spread="0.999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Contrast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.15" spread="1.213"/>
                    <measurement group_id="O2" value="-1.60" spread="1.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Comfort Measured With Visual Analog Scale (VAS)</title>
        <description>The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>OFPM With Air Optix Aqua</title>
            <description>OFPM with lotrafilcon B contact lenses for 30 days</description>
          </group>
          <group group_id="O2">
            <title>OFPM With Acuvue Oasys</title>
            <description>OFPM with senofilcon A contact lenses for 30 days</description>
          </group>
          <group group_id="O3">
            <title>BIOTRUE With Air Optix Aqua</title>
            <description>BIOTRUE with lotrafilcon B contact lenses for 30 days</description>
          </group>
          <group group_id="O4">
            <title>BIOTRUE With Acuvue Oasys</title>
            <description>BIOTRUE with senofilcon A contact lenses for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Comfort Measured With Visual Analog Scale (VAS)</title>
          <description>The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.</population>
          <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="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="20.25"/>
                    <measurement group_id="O2" value="81.1" spread="20.37"/>
                    <measurement group_id="O3" value="74.9" spread="28.43"/>
                    <measurement group_id="O4" value="82.2" spread="20.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Dryness Measured With Visual Analog Scale (VAS)</title>
        <description>The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>OFPM With Air Optix Aqua</title>
            <description>OFPM with lotrafilcon B contact lenses for 30 days</description>
          </group>
          <group group_id="O2">
            <title>OFPM With Acuvue Oasys</title>
            <description>OFPM with senofilcon A contact lenses for 30 days</description>
          </group>
          <group group_id="O3">
            <title>BIOTRUE With Air Optix Aqua</title>
            <description>BIOTRUE with lotrafilcon B contact lenses for 30 days</description>
          </group>
          <group group_id="O4">
            <title>BIOTRUE With Acuvue Oasys</title>
            <description>BIOTRUE with senofilcon A contact lenses for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Dryness Measured With Visual Analog Scale (VAS)</title>
          <description>The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.</population>
          <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="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" spread="20.41"/>
                    <measurement group_id="O2" value="22.2" spread="22.15"/>
                    <measurement group_id="O3" value="23.3" spread="25.65"/>
                    <measurement group_id="O4" value="22.5" spread="25.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Exposure Speed</title>
        <description>Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Air Optix Aqua</title>
            <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
          <group group_id="O2">
            <title>Acuvue Oasys</title>
            <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
        </group_list>
        <measure>
          <title>Average Exposure Speed</title>
          <description>Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
          <units>percent of area exposed/second</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.059" spread="15.1175"/>
                    <measurement group_id="O2" value="0.105" spread="24.4808"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Protected Area</title>
        <description>Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Air Optix Aqua</title>
            <description>Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
          <group group_id="O2">
            <title>Acuvue Oasys</title>
            <description>Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Protected Area</title>
          <description>Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.</description>
          <population>This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.</population>
          <units>percentage of lens surface covered</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.75" spread="15.990"/>
                    <measurement group_id="O2" value="77.79" spread="31.547"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study.</time_frame>
      <desc>An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.</desc>
      <group_list>
        <group group_id="E1">
          <title>AIR OPTIX AQUA</title>
          <description>Lotrafilcon B contact lenses worn for 60 days, replaced monthly</description>
        </group>
        <group group_id="E2">
          <title>ACUVUE OASYS With HYDRACLEAR</title>
          <description>Senofilcon A contact lenses worn for 60 days, replaced biweekly</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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Eye complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA">Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="36"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessie Lemp, DrPH</name_or_title>
      <organization>Alcon Research, Ltd.</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.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/NCT01699750
org study id: M-12-043 / ID11-59
nct id: NCT01699750
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and
      visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when
      used in conjunction with two contact lens care systems.
This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1),
      participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for
      contact lens care. Eligible participants will continue into the Investigational Phase (Phase
      2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with
      HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants
      will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Mean Ex-Vivo Total Lipid Uptake Per Lens
time frame: Day 30
description: The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.
measure: Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
time frame: Day 30
description: The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.
measure: LogMAR Time-Controlled Visual Acuity (TCVA)
time frame: Day 30
description: Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.
measure: Overall Comfort Measured With Visual Analog Scale (VAS)
time frame: Day 30
description: The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
measure: Overall Dryness Measured With Visual Analog Scale (VAS)
time frame: Day 30
description: The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
measure: Average Exposure Speed
time frame: Day 30
description: Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.
measure: Minimum Protected Area
time frame: Day 30
description: Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.
arm group label: Air Optix Aqua
arm group type: Experimental
description: Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
arm group label: Acuvue Oasys
arm group type: Active Comparator
description: Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
intervention type: Device
intervention name: Lotrafilcon B contact lenses
description: Silicone hydrogel contact lenses, Phase 2
arm group label: Air Optix Aqua
other name: AIR OPTIX® AQUA
other name: AOA
intervention type: Device
intervention name: Senofilcon A contact lenses
description: Silicone hydrogel contact lenses, Phase 2
arm group label: Acuvue Oasys
other name: ACUVUE® OASYS® with HYDRACLEAR®
other name: AVO
intervention type: Device
intervention name: OPTI-FREE® PUREMOIST® MPDS
description: Contact lens care system, Phase 2
arm group label: Acuvue Oasys
arm group label: Air Optix Aqua
other name: OFPM
intervention type: Device
intervention name: BIOTRUE®
description: Contact lens care system, Phase 2
arm group label: Acuvue Oasys
arm group label: Air Optix Aqua
intervention type: Device
intervention name: Balafilcon A contact lenses
description: Silicone hydrogel contact lenses worn for 30 days, Phase 1
arm group label: Acuvue Oasys
arm group label: Air Optix Aqua
other name: PureVision
intervention type: Device
intervention name: ReNu® Multiplus®
description: Contact lens care system used for 30 days, Phase 1
arm group label: Acuvue Oasys
arm group label: Air Optix Aqua
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jami Kern, PhD
role: Study Director
affiliation: Alcon Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
mesh term: Astigmatism
mesh term: Refractive Errors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 