<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/NCT01684046</url>
  </required_header>
  <id_info>
    <org_study_id>M-12-041</org_study_id>
    <nct_id>NCT01684046</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2</brief_title>
  <official_title>Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2</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 was to evaluate the performance of Opti-Free® PureMoist®&#xD;
      Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand&#xD;
      name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this 2-period crossover study, eligible participants were randomized to either Opti-Free®&#xD;
      PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses,&#xD;
      after which they switched to the alternate solution in Period 2. Each period was 30 days in&#xD;
      length. A 2-day washout period during which participants refrained from using a multi-purpose&#xD;
      contact lens solution preceded Period 1 and Period 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Lens Wear Comfort</measure>
    <time_frame>Day 30</time_frame>
    <description>Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, &quot;When I use this solution, I can comfortably wear my lenses,&quot; with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Myopia</condition>
  <condition>Hyperopia</condition>
  <condition>Contact Lens Comfort</condition>
  <arm_group>
    <arm_group_label>PureMoist - RevitaLens</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RevitaLens - PureMoist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Opti-Free® PureMoist® MPDS</intervention_name>
    <arm_group_label>PureMoist - RevitaLens</arm_group_label>
    <arm_group_label>RevitaLens - PureMoist</arm_group_label>
    <other_name>OPTI-FREE® PureMoist®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RevitaLens MPDS</intervention_name>
    <arm_group_label>PureMoist - RevitaLens</arm_group_label>
    <arm_group_label>RevitaLens - PureMoist</arm_group_label>
    <other_name>RevitaLens OcuTec®</other_name>
    <other_name>COMPLETE® RevitaLens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Habitual Contact Lenses</intervention_name>
    <description>Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.</description>
    <arm_group_label>PureMoist - RevitaLens</arm_group_label>
    <arm_group_label>RevitaLens - PureMoist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®,&#xD;
             Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear&#xD;
             basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to&#xD;
             Visit 1;&#xD;
&#xD;
          -  Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a&#xD;
             week) for the duration of the study, and wear lenses for 16 hours on 2 days during the&#xD;
             study;&#xD;
&#xD;
          -  Must have habitually used a biguanide preserved multi-purpose solution (other than&#xD;
             RevitaLens) for at least 30 days prior to Visit 1;&#xD;
&#xD;
          -  Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with&#xD;
             pre-study contact lenses at Visit 1;&#xD;
&#xD;
          -  Have access, capability and willingness to review and answer text messages;&#xD;
&#xD;
          -  Read, sign, and date IRB/IEC approved informed consent and privacy document before&#xD;
             enrollment;&#xD;
&#xD;
          -  Willing to follow the study procedures and visit schedule;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need to wear lenses on an extended wear (i.e overnight) basis during the study;&#xD;
&#xD;
          -  Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX&#xD;
             preserved lens care products;&#xD;
&#xD;
          -  Monocular (only one eye with functional vision) or fit with only one lens;&#xD;
&#xD;
          -  Wearing toric or multifocal contact lenses or fit with monovision;&#xD;
&#xD;
          -  Use of additional lens care products other than a biguanide preserved multi-purpose&#xD;
             solution such as daily or enzyme cleaners within the 1 week prior to Visit 1;&#xD;
&#xD;
          -  Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications,&#xD;
             with the exception of rewetting drops, within 7 days prior to Visit 1;&#xD;
&#xD;
          -  Abnormal ocular condition observed during the Visit 1 slit-lamp examination;&#xD;
&#xD;
          -  Current or history of ocular infections or severe inflammation within 6 months prior&#xD;
             to Visit 1;&#xD;
&#xD;
          -  Ocular surgery within the 12 months prior to Visit 1;&#xD;
&#xD;
          -  Participation in any other clinical trial within 30 days of enrollment;&#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>Jessie Lemp, MS</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>March 27, 2014</results_first_submitted>
  <results_first_submitted_qc>March 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 29, 2014</results_first_posted>
  <last_update_submitted>March 27, 2014</last_update_submitted>
  <last_update_submitted_qc>March 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multi-purpose solution</keyword>
  <keyword>silicone hydrogel</keyword>
  <keyword>contact lenses</keyword>
  <keyword>comfort</keyword>
  <keyword>Opti-Free</keyword>
  <keyword>RevitaLens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 5 study centers located in the US, 2 study centers located in the UK, and 3 study centers located in Germany.</recruitment_details>
      <pre_assignment_details>Of the 196 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (192).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PureMoist - RevitaLens</title>
          <description>Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
        </group>
        <group group_id="P2">
          <title>RevitaLens - PureMoist</title>
          <description>RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1, First 30 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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>
          <title>Period 2, Second 30 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all participants who were exposed to a study regimen (test or control).</population>
      <group_list>
        <group group_id="B1">
          <title>PureMoist / RevitaLens</title>
          <description>Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="192"/>
          </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="32.0" spread="11.42"/>
                  </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="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Lens Wear Comfort</title>
        <description>Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, &quot;When I use this solution, I can comfortably wear my lenses,&quot; with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>PureMoist</title>
            <description>Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</description>
          </group>
          <group group_id="O2">
            <title>RevitaLens</title>
            <description>RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Lens Wear Comfort</title>
          <description>Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, &quot;When I use this solution, I can comfortably wear my lenses,&quot; with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.</description>
          <population>This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.</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="183"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.89"/>
                    <measurement group_id="O2" value="4.3" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AE) were collected for the duration of the study (4 months). AEs were elicited by non-direct questioning of the participant and spontaneous reporting by the participant. AEs were recorded at every visit.</time_frame>
      <desc>An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants who were exposed to a study regimen (test or control), based on treatment-specific exposure.</desc>
      <group_list>
        <group group_id="E1">
          <title>PureMoist</title>
          <description>Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</description>
        </group>
        <group group_id="E2">
          <title>RevitaLens</title>
          <description>RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</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="190"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="192"/>
              </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="190"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="192"/>
              </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, GMA Brand Lead</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/NCT01684046
org study id: M-12-041
nct id: NCT01684046
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist®
      Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand
      name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.
In this 2-period crossover study, eligible participants were randomized to either Opti-Free®
      PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses,
      after which they switched to the alternate solution in Period 2. Each period was 30 days in
      length. A 2-day washout period during which participants refrained from using a multi-purpose
      contact lens solution preceded Period 1 and Period 2.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Subjective Lens Wear Comfort
time frame: Day 30
description: Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
arm group label: PureMoist - RevitaLens
arm group type: Other
description: Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
arm group label: RevitaLens - PureMoist
arm group type: Other
description: RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
intervention type: Device
intervention name: Opti-Free® PureMoist® MPDS
arm group label: PureMoist - RevitaLens
arm group label: RevitaLens - PureMoist
other name: OPTI-FREE® PureMoist®
intervention type: Device
intervention name: RevitaLens MPDS
arm group label: PureMoist - RevitaLens
arm group label: RevitaLens - PureMoist
other name: RevitaLens OcuTec®
other name: COMPLETE® RevitaLens
intervention type: Device
intervention name: Habitual Contact Lenses
description: Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
arm group label: PureMoist - RevitaLens
arm group label: RevitaLens - PureMoist
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessie Lemp, MS
role: Study Director
affiliation: Alcon Research
country: United States
responsible party type: Sponsor
mesh term: Hyperopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 