<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/NCT01684033</url>
  </required_header>
  <id_info>
    <org_study_id>M-12-038</org_study_id>
    <secondary_id>1941/ALC</secondary_id>
    <nct_id>NCT01684033</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1</brief_title>
  <official_title>Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1</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 Biotrue™ Multipurpose Solution (MPS)&#xD;
      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® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution in Period 1&#xD;
      for use with their habitual contact lenses, after which they switched to the alternate&#xD;
      solution in Period 2. Each period was 30 days in length. A 2-day washout period during which&#xD;
      participants refrained from using a multi-purpose contact lens solution preceded Period 1 and&#xD;
      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>Corneal Staining</measure>
    <time_frame>Day 30</time_frame>
    <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Corneal Staining at Day 30</measure>
    <time_frame>Baseline (Day 0), Day 30</time_frame>
    <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Myopia</condition>
  <condition>Hyperopia</condition>
  <condition>Contact Lens Comfort</condition>
  <arm_group>
    <arm_group_label>PureMoist - Biotrue</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biotrue - PureMoist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Biotrue™ MPS 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>Biotrue - PureMoist</arm_group_label>
    <arm_group_label>PureMoist - Biotrue</arm_group_label>
    <other_name>OPTI-FREE® PureMoist™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biotrue™ MPS</intervention_name>
    <arm_group_label>Biotrue - PureMoist</arm_group_label>
    <arm_group_label>PureMoist - Biotrue</arm_group_label>
    <other_name>Biotrue™</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>Biotrue - PureMoist</arm_group_label>
    <arm_group_label>PureMoist - Biotrue</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 one 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 two days during&#xD;
             the study;&#xD;
&#xD;
          -  Must have habitually used a Biguanide preserved multi-purpose solution (other than&#xD;
             Biotrue) 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 multipurpose&#xD;
             solution such as daily or enzyme cleaners within the one 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 12, 2014</results_first_submitted>
  <results_first_submitted_qc>March 12, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 17, 2014</results_first_posted>
  <last_update_submitted>March 12, 2014</last_update_submitted>
  <last_update_submitted_qc>March 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 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>Biotrue</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, 3 study centers located in the UK, and 2 study centers located in Germany.</recruitment_details>
      <pre_assignment_details>Of the 207 enrolled, 9 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) (198).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PureMoist - Biotrue</title>
          <description>Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.</description>
        </group>
        <group group_id="P2">
          <title>Biotrue - PureMoist</title>
          <description>Biotrue™ MPS, 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="99"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" 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="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_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="95"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" 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="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_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 / Biotrue</title>
          <description>Opti-Free® PureMoist® MPDS and Biotrue™ MPS 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="198"/>
          </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="31.7" spread="11.48"/>
                  </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="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Corneal Staining</title>
        <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
        <time_frame>Day 30</time_frame>
        <population>This analysis population group includes all participants who were exposed to both treatment regimens.</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>Biotrue</title>
            <description>Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Staining</title>
          <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
          <population>This analysis population group includes all participants who were exposed to both treatment regimens.</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="192"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.30"/>
                    <measurement group_id="O2" value="2.8" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Corneal Staining at Day 30</title>
        <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
        <time_frame>Baseline (Day 0), Day 30</time_frame>
        <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>Biotrue</title>
            <description>Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Corneal Staining at Day 30</title>
          <description>Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.59"/>
                    <measurement group_id="O2" value="1.6" spread="2.91"/>
                  </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>Biotrue</title>
          <description>Biotrue™ MPS 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="196"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="194"/>
              </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="196"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="194"/>
              </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/NCT01684033
org study id: M-12-038
secondary id: 1941/ALC
nct id: NCT01684033
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 Biotrue™ Multipurpose Solution (MPS)
      in silicone hydrogel contact lens wearers.
In this 2-period crossover study, eligible participants were randomized to either Opti-Free®
      PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution 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: Corneal Staining
time frame: Day 30
description: Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
measure: Change From Baseline in Corneal Staining at Day 30
time frame: Baseline (Day 0), Day 30
description: Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
arm group label: PureMoist - Biotrue
arm group type: Other
description: Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
arm group label: Biotrue - PureMoist
arm group type: Other
description: Biotrue™ MPS 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: Biotrue - PureMoist
arm group label: PureMoist - Biotrue
other name: OPTI-FREE® PureMoist™
intervention type: Device
intervention name: Biotrue™ MPS
arm group label: Biotrue - PureMoist
arm group label: PureMoist - Biotrue
other name: Biotrue™
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: Biotrue - PureMoist
arm group label: PureMoist - Biotrue
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: 