<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/NCT02189863</url>
  </required_header>
  <id_info>
    <org_study_id>M-14-009</org_study_id>
    <nct_id>NCT02189863</nct_id>
  </id_info>
  <brief_title>Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses</brief_title>
  <official_title>Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses</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 overall objective of this study is to compare the effect on simulated driving performance&#xD;
      of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF)&#xD;
      soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a&#xD;
      standardised driving simulation for each of the two treatments. A fresh pair of lenses was&#xD;
      dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD)&#xD;
      and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional&#xD;
      same-day assessment. Habitual correction was worn for an acclimatization drive in the driving&#xD;
      simulator during Period 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)</measure>
    <time_frame>Week 2, each period</time_frame>
    <description>Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standard Deviation of Lateral Positioning</measure>
    <time_frame>Week 2, each period</time_frame>
    <description>The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotrafilcon B MF</intervention_name>
    <description>Multifocal contact lenses worn in both eyes</description>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
    <other_name>AIR OPTIX® Aqua Multifocal</other_name>
    <other_name>AOAMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotrafilcon B MV</intervention_name>
    <description>Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near</description>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
    <other_name>AIR OPTIX® Aqua</other_name>
    <other_name>AOAMV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lotrafilcon B SVD</intervention_name>
    <description>Spherical contact lenses worn with both eyes corrected for distance</description>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
    <other_name>AIR OPTIX® Aqua</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comfilcon A MF</intervention_name>
    <description>Multifocal contact lenses worn in both eyes</description>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
    <other_name>Biofinity® Multifocal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Habitual contact lenses</intervention_name>
    <description>Contact lenses worn in both eyes per subject's habitual prescription</description>
    <arm_group_label>AOAMF, then AOAMV</arm_group_label>
    <arm_group_label>AOAMV, then AOAMF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current soft contact lens wearers (for 1 month or more) with distance spherical power&#xD;
             requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -10.00D, and who have never&#xD;
             tried and then failed in monovision or AOAMF.&#xD;
&#xD;
          -  Medium to high presbyopia, i.e. spectacle add requirement of +1.50D or more.&#xD;
&#xD;
          -  Astigmatism, if present, ≤1.00D in both eyes.&#xD;
&#xD;
          -  Distance visual acuity (VA) correctable to 20/30 (+0.2 logMAR) in both eyes.&#xD;
&#xD;
          -  Within the normal ranges for binocular vision for distance (8Δ exophoria, ≤8Δ&#xD;
             esophoria), vertical phoria = 1.5Δ hypo or hyper.&#xD;
&#xD;
          -  Full United Kingdom driving license held for at least 3 years, with at least 2000&#xD;
             miles driven per year.&#xD;
&#xD;
          -  Willing to wear study lenses at least 5 days per week.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing AIR OPTIX® Multifocal CL user.&#xD;
&#xD;
          -  Sphere requirement in the range +0.75 to -0.75D in both eyes.&#xD;
&#xD;
          -  Previous refractive surgery.&#xD;
&#xD;
          -  Ocular/systemic medical condition or medical treatment contra-indicating contact lens&#xD;
             wear or driving simulation.&#xD;
&#xD;
          -  Participation in a clinical study within the past 30 days.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sr. Clinical Manager, Global Medical Affairs, Vision Care</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>December 14, 2015</results_first_submitted>
  <results_first_submitted_qc>December 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 20, 2016</results_first_posted>
  <last_update_submitted>January 21, 2016</last_update_submitted>
  <last_update_submitted_qc>January 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Driving Simulator</keyword>
  <keyword>Air Optix Aqua</keyword>
  <keyword>AOAMF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 2 investigational sites located in the UK.</recruitment_details>
      <pre_assignment_details>Of the 33 enrolled, 6 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who successfully tried at least one study lens (27).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AOAMV, Then AOAMF</title>
          <description>Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2</description>
        </group>
        <group group_id="P2">
          <title>AOAMF, Then AOAMV</title>
          <description>Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First 2 Weeks</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Motion Sickness</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Second 2 Weeks</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
              </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 randomized participants who successfully tried at least one study lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
          </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="55.4" spread="5.4"/>
                  </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="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)</title>
        <description>Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.</description>
        <time_frame>Week 2, each period</time_frame>
        <population>This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).</population>
        <group_list>
          <group group_id="O1">
            <title>AOAMV</title>
            <description>Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks</description>
          </group>
          <group group_id="O2">
            <title>AOAMF</title>
            <description>Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)</title>
          <description>Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.</description>
          <population>This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" spread="0.22"/>
                    <measurement group_id="O2" value="1.88" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Standard Deviation of Lateral Positioning</title>
        <description>The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.</description>
        <time_frame>Week 2, each period</time_frame>
        <population>This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).</population>
        <group_list>
          <group group_id="O1">
            <title>AOAMV</title>
            <description>Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks</description>
          </group>
          <group group_id="O2">
            <title>AOAMF</title>
            <description>Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Deviation of Lateral Positioning</title>
          <description>The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.</description>
          <population>This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.06"/>
                    <measurement group_id="O2" value="0.35" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 4 weeks). This analysis group includes all randomized subjects who successfully tried at least one study lens, based on treatment-specific exposure.</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. Ocular adverse events are presented for both study eye and non-study eye.</desc>
      <group_list>
        <group group_id="E1">
          <title>AOAMV</title>
          <description>Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks</description>
        </group>
        <group group_id="E2">
          <title>AOAMF</title>
          <description>Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks</description>
        </group>
        <group group_id="E3">
          <title>Lotra B SVD</title>
          <description>Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment</description>
        </group>
        <group group_id="E4">
          <title>Biofinity MF</title>
          <description>Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment</description>
        </group>
        <group group_id="E5">
          <title>Habitual</title>
          <description>Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
              </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="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
              </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>Global Brand Lead, Global Medical Affairs, Vision Care</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/NCT02189863
org study id: M-14-009
nct id: NCT02189863
lead sponsor: 
has dmc: No
The overall objective of this study is to compare the effect on simulated driving performance
      of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.
In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF)
      soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a
      standardised driving simulation for each of the two treatments. A fresh pair of lenses was
      dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD)
      and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional
      same-day assessment. Habitual correction was worn for an acclimatization drive in the driving
      simulator during Period 1.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Investigator)
measure: Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)
time frame: Week 2, each period
description: Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.
measure: Standard Deviation of Lateral Positioning
time frame: Week 2, each period
description: The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.
arm group label: AOAMV, then AOAMF
arm group type: Other
description: Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
arm group label: AOAMF, then AOAMV
arm group type: Other
description: Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
intervention type: Device
intervention name: Lotrafilcon B MF
description: Multifocal contact lenses worn in both eyes
arm group label: AOAMF, then AOAMV
arm group label: AOAMV, then AOAMF
other name: AIR OPTIX® Aqua Multifocal
other name: AOAMF
intervention type: Device
intervention name: Lotrafilcon B MV
description: Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
arm group label: AOAMF, then AOAMV
arm group label: AOAMV, then AOAMF
other name: AIR OPTIX® Aqua
other name: AOAMV
intervention type: Device
intervention name: Lotrafilcon B SVD
description: Spherical contact lenses worn with both eyes corrected for distance
arm group label: AOAMF, then AOAMV
arm group label: AOAMV, then AOAMF
other name: AIR OPTIX® Aqua
intervention type: Device
intervention name: Comfilcon A MF
description: Multifocal contact lenses worn in both eyes
arm group label: AOAMF, then AOAMV
arm group label: AOAMV, then AOAMF
other name: Biofinity® Multifocal
intervention type: Device
intervention name: Habitual contact lenses
description: Contact lenses worn in both eyes per subject's habitual prescription
arm group label: AOAMF, then AOAMV
arm group label: AOAMV, then AOAMF
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
last name: Sr. Clinical Manager, Global Medical Affairs, Vision Care
role: Study Director
affiliation: Alcon Research
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 