<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/NCT03026257</url>
  </required_header>
  <id_info>
    <org_study_id>LCW773-P001</org_study_id>
    <nct_id>NCT03026257</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of a HYDRAGLYDE® Regimen</brief_title>
  <official_title>Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon, a Novartis Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses&#xD;
      cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the&#xD;
      control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual&#xD;
      multi-purpose solution (MPS) for cholesterol uptake.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">August 18, 2017</completion_date>
  <primary_completion_date type="Actual">August 18, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ex Vivo Total Cholesterol Uptake at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">323</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Myopia</condition>
  <condition>Hypermetropia</condition>
  <arm_group>
    <arm_group_label>AOHG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Habitual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotrafilcon B contact lenses with added wetting agent</intervention_name>
    <description>Silicone hydrogel contact lenses</description>
    <arm_group_label>AOHG</arm_group_label>
    <other_name>AIR OPTIX® plus HYDRAGLYDE® (AOHG)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Samfilcon A contact lenses</intervention_name>
    <description>Habitual silicone hydrogel contact lenses</description>
    <arm_group_label>Habitual</arm_group_label>
    <other_name>Bausch + Lomb ULTRA™ (Ultra)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent</intervention_name>
    <description>Multi-purpose disinfecting solution for contact lens care</description>
    <arm_group_label>AOHG</arm_group_label>
    <other_name>OPTI-FREE® PureMoist® (OFPM)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydrogen peroxide-based contact lens solution with added wetting agent</intervention_name>
    <description>Solution for contact lens cleaning and disinfecting</description>
    <arm_group_label>AOHG</arm_group_label>
    <other_name>CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Senofilcon C contact lenses</intervention_name>
    <description>Habitual silicone hydrogel contact lenses</description>
    <arm_group_label>Habitual</arm_group_label>
    <other_name>Johnson &amp; Johnson ACUVUE® VITA™ (Vita)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Senofilcon A contact lenses</intervention_name>
    <description>Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks</description>
    <arm_group_label>Habitual</arm_group_label>
    <other_name>Johnson &amp; Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comfilcon A contact lenses</intervention_name>
    <description>Habitual silicone hydrogel contact lenses</description>
    <arm_group_label>Habitual</arm_group_label>
    <other_name>CooperVision® Biofinity® (Biofinity)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Habitual Multi-Purpose Solution (HMPS)</intervention_name>
    <description>Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions</description>
    <arm_group_label>Habitual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must sign informed consent document;&#xD;
&#xD;
          -  Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual&#xD;
             lenses;&#xD;
&#xD;
          -  Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye&#xD;
             and spectacle add &lt;+0.50 D in each eye;&#xD;
&#xD;
          -  Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly&#xD;
             or senofilcon A 2-week replacement lens within the power range of lens powers&#xD;
             available;&#xD;
&#xD;
          -  Current user of an MPS (excluding OFPM) to care for lenses;&#xD;
&#xD;
          -  Willing to answer text messages on a daily basis during the study;&#xD;
&#xD;
          -  Willing to discontinue artificial tears during the study and rewetting drops on the&#xD;
             days of study visits;&#xD;
&#xD;
          -  Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20&#xD;
             consecutive minutes at least twice a week and willing to continue for the duration of&#xD;
             the study;&#xD;
&#xD;
          -  Other protocol specific inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Habitual lens wear in an extended wear modality (routinely sleeping in lenses&#xD;
             overnight for 1 or more nights per week);&#xD;
&#xD;
          -  Any anterior segment infection, inflammation, disease or abnormality that&#xD;
             contraindicates contact lens wear;&#xD;
&#xD;
          -  History of herpetic keratitis, corneal surgery or irregular cornea;&#xD;
&#xD;
          -  Prior refractive surgery;&#xD;
&#xD;
          -  Any use of systemic or ocular medications for which contact lens wear could be&#xD;
             contraindicated as determined by the investigator;&#xD;
&#xD;
          -  Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids&#xD;
             within the past 7 days;&#xD;
&#xD;
          -  Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and&#xD;
             not willing to discontinue during the study;&#xD;
&#xD;
          -  Monocular (only 1 eye with functional vision) or fit with only 1 lens;&#xD;
&#xD;
          -  Known pregnancy or lactating;&#xD;
&#xD;
          -  Other protocol specific 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>Clinical Manager, Global Med Affairs, GCRA</last_name>
    <role>Study Director</role>
    <affiliation>Alcon, A Novartis Division</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Hildesheim</city>
        <zip>31134</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Jena</city>
        <zip>07745</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>July 20, 2018</results_first_submitted>
  <results_first_submitted_qc>July 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2018</results_first_posted>
  <last_update_submitted>July 20, 2018</last_update_submitted>
  <last_update_submitted_qc>July 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</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>Refractive Errors</mesh_term>
    <mesh_term>Hyperopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrogen Peroxide</mesh_term>
    <mesh_term>Contact Lens Solutions</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03026257/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03026257/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).</recruitment_details>
      <pre_assignment_details>Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AOHG/CCP</title>
          <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent</description>
        </group>
        <group group_id="P2">
          <title>AOHG/OFPM</title>
          <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent</description>
        </group>
        <group group_id="P3">
          <title>Biofinity/HMPS</title>
          <description>Habitual silicone hydrogel (SiHy) contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)</description>
        </group>
        <group group_id="P4">
          <title>Vita/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="P5">
          <title>Ultra/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="P6">
          <title>Oasys/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all randomized and exposed to a study lens on Day 1 or a study regimen (lens and lens care system (LCS)) thereafter (Full Analysis Set).</population>
      <group_list>
        <group group_id="B1">
          <title>AOHG/CCP</title>
          <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent</description>
        </group>
        <group group_id="B2">
          <title>AOHG/OFPM</title>
          <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent</description>
        </group>
        <group group_id="B3">
          <title>Biofinity/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="B4">
          <title>Vita/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="B5">
          <title>Ultra/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="B6">
          <title>Oasys/HMPS</title>
          <description>Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS</description>
        </group>
        <group group_id="B7">
          <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="60"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="25"/>
            <count group_id="B5" value="23"/>
            <count group_id="B6" value="46"/>
            <count group_id="B7" value="252"/>
          </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="27.7" spread="7.0"/>
                    <measurement group_id="B2" value="27.8" spread="6.0"/>
                    <measurement group_id="B3" value="28.2" spread="5.9"/>
                    <measurement group_id="B4" value="28.2" spread="5.7"/>
                    <measurement group_id="B5" value="28.8" spread="7.2"/>
                    <measurement group_id="B6" value="30.4" spread="8.2"/>
                    <measurement group_id="B7" value="28.4" spread="6.8"/>
                  </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="39"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="35"/>
                    <measurement group_id="B7" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="43"/>
                    <measurement group_id="B7" value="238"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ex Vivo Total Cholesterol Uptake at Day 30</title>
        <description>The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.</description>
        <time_frame>Day 30</time_frame>
        <population>Full Analysis Set with cholesterol uptake measured</population>
        <group_list>
          <group group_id="O1">
            <title>AOHG/CCP</title>
            <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent</description>
          </group>
          <group group_id="O2">
            <title>AOHG/OFPM</title>
            <description>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent</description>
          </group>
          <group group_id="O3">
            <title>Biofinity/HMPS</title>
            <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
          </group>
          <group group_id="O4">
            <title>Vita/HMPS</title>
            <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
          </group>
          <group group_id="O5">
            <title>Ultra/HMPS</title>
            <description>Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS</description>
          </group>
          <group group_id="O6">
            <title>Oasys/HMPS</title>
            <description>Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS</description>
          </group>
        </group_list>
        <measure>
          <title>Ex Vivo Total Cholesterol Uptake at Day 30</title>
          <description>The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.</description>
          <population>Full Analysis Set with cholesterol uptake measured</population>
          <units>μg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.18"/>
                    <measurement group_id="O2" value="0.28" spread="0.48"/>
                    <measurement group_id="O3" value="2.17" spread="1.47"/>
                    <measurement group_id="O4" value="4.18" spread="3.25"/>
                    <measurement group_id="O5" value="2.07" spread="1.48"/>
                    <measurement group_id="O6" value="2.19" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>General Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Lens insertion (Day 1) through study completion, an average of 30 days</time_frame>
      <desc>Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all subjects/eyes exposed to study lens and/or study LCS evaluated in this study as a regimen (Safety Analysis Set). &quot;At risk&quot; population for ocular AEs is reported in units of eyes, as treated.</desc>
      <group_list>
        <group group_id="E1">
          <title>AOHG/CCP Ocular</title>
          <description>Eyes exposed to AOHG contact lenses and CCP for lens care</description>
        </group>
        <group group_id="E2">
          <title>AOHG/CCP Nonocular</title>
          <description>Subjects exposed to AOHG contact lenses and CCP for lens care</description>
        </group>
        <group group_id="E3">
          <title>AOHG/OFPM Ocular</title>
          <description>Eyes exposed to AOHG contact lenses and OFPM for lens care</description>
        </group>
        <group group_id="E4">
          <title>AOHG/OFPM Nonocular</title>
          <description>Subjects exposed to AOHG contact lenses and OFPM for lens care</description>
        </group>
        <group group_id="E5">
          <title>Habitual SiHy/MPS Ocular</title>
          <description>Eyes exposed to habitual SiHy contact lenses and habitual MPS for lens care</description>
        </group>
        <group group_id="E6">
          <title>Habitual SiHy/MPS Nonocular</title>
          <description>Subjects exposed to habitual SiHy contact lenses and habitual MPS for lens care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="129"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="129"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="129"/>
              </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>Senior Clinical Project Lead, GCRA - Clin Dev Vision Care</name_or_title>
      <organization>Alcon, A Novartis Division</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/NCT03026257
org study id: LCW773-P001
nct id: NCT03026257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses
      cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the
      control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual
      multi-purpose solution (MPS) for cholesterol uptake.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Ex Vivo Total Cholesterol Uptake at Day 30
time frame: Day 30
description: The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
arm group label: AOHG
arm group type: Experimental
description: Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
arm group label: Habitual
arm group type: Active Comparator
description: Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
intervention type: Device
intervention name: Lotrafilcon B contact lenses with added wetting agent
description: Silicone hydrogel contact lenses
arm group label: AOHG
other name: AIR OPTIX® plus HYDRAGLYDE® (AOHG)
intervention type: Device
intervention name: Samfilcon A contact lenses
description: Habitual silicone hydrogel contact lenses
arm group label: Habitual
other name: Bausch + Lomb ULTRA™ (Ultra)
intervention type: Device
intervention name: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
description: Multi-purpose disinfecting solution for contact lens care
arm group label: AOHG
other name: OPTI-FREE® PureMoist® (OFPM)
intervention type: Device
intervention name: Hydrogen peroxide-based contact lens solution with added wetting agent
description: Solution for contact lens cleaning and disinfecting
arm group label: AOHG
other name: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
intervention type: Device
intervention name: Senofilcon C contact lenses
description: Habitual silicone hydrogel contact lenses
arm group label: Habitual
other name: Johnson & Johnson ACUVUE® VITA™ (Vita)
intervention type: Device
intervention name: Senofilcon A contact lenses
description: Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
arm group label: Habitual
other name: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)
intervention type: Device
intervention name: Comfilcon A contact lenses
description: Habitual silicone hydrogel contact lenses
arm group label: Habitual
other name: CooperVision® Biofinity® (Biofinity)
intervention type: Device
intervention name: Habitual Multi-Purpose Solution (HMPS)
description: Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
arm group label: Habitual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Manager, Global Med Affairs, GCRA
role: Study Director
affiliation: Alcon, A Novartis Division
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
mesh term: Hyperopia
mesh term: Hydrogen Peroxide
mesh term: Contact Lens Solutions
mesh term: Pharmaceutical Solutions
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 