<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/NCT02235831</url>
  </required_header>
  <id_info>
    <org_study_id>CLT330-P001</org_study_id>
    <nct_id>NCT02235831</nct_id>
  </id_info>
  <brief_title>DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance</brief_title>
  <official_title>DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort&#xD;
      Plus® (DACP) MF contact lens using new objective measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3&#xD;
      products in randomized order and used 1 product at a time for a duration of 5±1 days before&#xD;
      switching to the next assigned product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance</measure>
    <time_frame>Day 5, each product</time_frame>
    <description>Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Presbyopia</condition>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>DACP MF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DACP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DACP MF (Low Add)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nelfilcon A MF contact lenses (DACP MF)</intervention_name>
    <description>Multifocal contact lenses in Low, Medium, High Add</description>
    <arm_group_label>DACP</arm_group_label>
    <arm_group_label>DACP MF</arm_group_label>
    <arm_group_label>DACP MF (Low Add)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nelfilcon A single vision contact lenses (DACP)</intervention_name>
    <arm_group_label>DACP</arm_group_label>
    <arm_group_label>DACP MF</arm_group_label>
    <arm_group_label>DACP MF (Low Add)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during&#xD;
             the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week&#xD;
&#xD;
          -  Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)&#xD;
&#xD;
          -  Requiring lenses within the power range of both study contact lenses to be fitted&#xD;
&#xD;
          -  Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1&#xD;
&#xD;
          -  Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance&#xD;
&#xD;
          -  Acceptable fit with both study contact lenses&#xD;
&#xD;
          -  Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours&#xD;
             per day, every day if possible&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current multifocal contact lens wearer&#xD;
&#xD;
          -  Current monovision wearer or failed attempt with monovision&#xD;
&#xD;
          -  Ocular anterior segment infection, inflammation, abnormality, or active disease that&#xD;
             would contraindicate contact lens wear&#xD;
&#xD;
          -  Use of systemic or ocular medications which contact lens wear could be contraindicated&#xD;
             as determined by the investigator&#xD;
&#xD;
          -  Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial&#xD;
&#xD;
          -  Any moderate or severe ocular condition observed during the slitlamp examination at&#xD;
             the enrollment visit&#xD;
&#xD;
          -  History of herpetic keratitis, ocular surgery or irregular cornea&#xD;
&#xD;
          -  Prior refractive surgery (e.g. LASIK, PRK, etc)&#xD;
&#xD;
          -  Monocular (only 1 eye with functional vision) or fit with only 1 lens&#xD;
&#xD;
          -  Habitually uncorrected anisometropia &gt;2.00D&#xD;
&#xD;
          -  Clinically significant anisocoria&#xD;
&#xD;
          -  Participation in any clinical trial within 30 days of the enrollment visit&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Manager, EMEA</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>October 30, 2015</results_first_submitted>
  <results_first_submitted_qc>December 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 18, 2016</results_first_posted>
  <last_update_submitted>June 8, 2016</last_update_submitted>
  <last_update_submitted_qc>June 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DACP MF</keyword>
  <keyword>DAILIES AquaComfort Plus® Multifocal</keyword>
  <keyword>presbyopia</keyword>
  <keyword>visual performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 1 study center located in Spain.</recruitment_details>
      <pre_assignment_details>Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Seq I</title>
          <description>DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
        <group group_id="P2">
          <title>Seq 2</title>
          <description>DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
        <group group_id="P3">
          <title>Seq 3</title>
          <description>DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
        <group group_id="P4">
          <title>Seq 4</title>
          <description>DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
        <group group_id="P5">
          <title>Seq 5</title>
          <description>DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
        <group group_id="P6">
          <title>Seq 6</title>
          <description>DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1, First 5 Days of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2, Second 5 Days of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3, Third 5 Days of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all subjects/eyes exposed to any investigational product evaluated in this study.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </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="50.8" spread="4.18"/>
                  </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="14"/>
                  </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>Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance</title>
        <description>Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.</description>
        <time_frame>Day 5, each product</time_frame>
        <population>This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).</population>
        <group_list>
          <group group_id="O1">
            <title>Monovision</title>
            <description>Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.</description>
          </group>
          <group group_id="O2">
            <title>DACP MF</title>
            <description>Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance</title>
          <description>Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.</description>
          <population>This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).</population>
          <units>diopter*logMar</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Near</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09"/>
                    <measurement group_id="O2" value="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24"/>
                    <measurement group_id="O2" value="0.36"/>
                  </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 19 days). This analysis group includes all subjects exposed to any investigational product evaluated in this study, 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. AEs were reported by the subject or observed by the investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>Monovision</title>
          <description>Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.</description>
        </group>
        <group group_id="E2">
          <title>DACP MF</title>
          <description>Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.</description>
        </group>
        <group group_id="E3">
          <title>DACP MF (Low Add)</title>
          <description>Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </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>Sr. Global Brand Lead, GCRA, Vision Care</name_or_title>
      <organization>Alcon Research, Ltd.</organization>
      <phone>1-888-451-3937</phone>
    </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/NCT02235831
org study id: CLT330-P001
nct id: NCT02235831
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort
      Plus® (DACP) MF contact lens using new objective measurements.
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3
      products in randomized order and used 1 product at a time for a duration of 5±1 days before
      switching to the next assigned product.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
time frame: Day 5, each product
description: Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
arm group label: DACP MF
arm group type: Experimental
description: DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).
arm group label: DACP
arm group type: Active Comparator
description: DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).
arm group label: DACP MF (Low Add)
arm group type: Active Comparator
description: DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).
intervention type: Device
intervention name: Nelfilcon A MF contact lenses (DACP MF)
description: Multifocal contact lenses in Low, Medium, High Add
arm group label: DACP
arm group label: DACP MF
arm group label: DACP MF (Low Add)
intervention type: Device
intervention name: Nelfilcon A single vision contact lenses (DACP)
arm group label: DACP
arm group label: DACP MF
arm group label: DACP MF (Low Add)
criteria: 
gender: All
minimum age: 41 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clinical Manager, EMEA
role: Study Director
affiliation: Alcon Research
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Refractive Errors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 