<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/NCT03757039</url>
  </required_header>
  <id_info>
    <org_study_id>CLT792-P001</org_study_id>
    <nct_id>NCT03757039</nct_id>
  </id_info>
  <brief_title>Multifocal Visual Performance Study</brief_title>
  <official_title>Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial was to compare the functional visual performance of Precision&#xD;
      Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a&#xD;
      presbyopic population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available&#xD;
      multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles.&#xD;
      Subjects were expected to attend 1 or 2 office visits. This study was terminated early by&#xD;
      Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Management Decision&#xD;
  </why_stopped>
  <start_date type="Actual">December 16, 2018</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)</measure>
    <time_frame>Day 1, after up to 3 hours of wear</time_frame>
    <description>The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Multifocal Contact Lenses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAL Spectacles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multifocal soft contact lenses</intervention_name>
    <description>Commercially available contact lenses</description>
    <arm_group_label>Multifocal Contact Lenses</arm_group_label>
    <other_name>DAILIES TOTAL1® Multifocal contact lenses (DT1 MF)</other_name>
    <other_name>DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF)</other_name>
    <other_name>AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive addition lens spectacles</intervention_name>
    <description>Per subject's habitual prescription</description>
    <arm_group_label>PAL Spectacles</arm_group_label>
    <other_name>PAL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal eyes, other than correction for refractive error;&#xD;
&#xD;
          -  Habitual correction of either any multifocal contact lens with a maximum add of +2.00&#xD;
             Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00 D;&#xD;
&#xD;
          -  Wears habitual correction at least 5 days per week and at least 6 hours per day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Monocular subjects;&#xD;
&#xD;
          -  Subjects fit with only one contact lens;&#xD;
&#xD;
          -  Known pregnancy or lactating;&#xD;
&#xD;
          -  History of or planned refractive surgery or irregular cornea in either eye.&#xD;
&#xD;
        Other protocol-specified inclusion and/or exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>58 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Clinical Manager, CDMA</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204-2020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B4 7ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>March 10, 2020</results_first_submitted>
  <results_first_submitted_qc>March 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 25, 2020</results_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contact lenses</keyword>
  <keyword>multifocal</keyword>
  <keyword>spectacles</keyword>
  <keyword>glasses</keyword>
  <keyword>progressive</keyword>
  <keyword>vision</keyword>
  <keyword>eyes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03757039/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03757039/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).</recruitment_details>
      <pre_assignment_details>Of the 42 enrolled, 1 subject was exited from the study as a screen failure prior to randomization. This reporting group includes all randomized/assigned subjects (41).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Multifocal Contact Lenses</title>
          <description>All subjects randomized to multifocal contact lenses (AOHG MF, DT1 MF, or DACP MF)</description>
        </group>
        <group group_id="P2">
          <title>PAL Spectacles Wearers</title>
          <description>All subjects assigned to progressive addition lens (PAL) spectacles</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>AOHG MF</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>DT1 MF</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>DACP MF</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="9"/>
              </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 subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).</population>
      <group_list>
        <group group_id="B1">
          <title>AOHG MF</title>
          <description>All subjects randomized to AOHG MF</description>
        </group>
        <group group_id="B2">
          <title>DT1 MF</title>
          <description>All subjects randomized to DT1 MF</description>
        </group>
        <group group_id="B3">
          <title>DACP MF</title>
          <description>All subjects randomized to DACP MF</description>
        </group>
        <group group_id="B4">
          <title>PALs</title>
          <description>All subjects assigned to PALs</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="41"/>
          </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="52.1" spread="4.1"/>
                    <measurement group_id="B2" value="52.5" spread="4.1"/>
                    <measurement group_id="B3" value="51.9" spread="4.0"/>
                    <measurement group_id="B4" value="51.7" spread="3.6"/>
                    <measurement group_id="B5" value="52.0" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)</title>
        <description>The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.</description>
        <time_frame>Day 1, after up to 3 hours of wear</time_frame>
        <population>This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (Full Analysis Set).</population>
        <group_list>
          <group group_id="O1">
            <title>Multifocal Contact Lenses</title>
            <description>Multifocal soft contact lenses (AOHG MF, DACP MF, DT1 MF combined) according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.</description>
          </group>
          <group group_id="O2">
            <title>PAL Spectacles</title>
            <description>Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)</title>
          <description>The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.</description>
          <population>This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (Full Analysis Set).</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="32"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.602" spread="1.136"/>
                    <measurement group_id="O2" value="2.774" spread="0.839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from time of enrollment until study exit, typically up to approximately 14 days.</time_frame>
      <desc>This analysis population includes all subjects exposed to any study product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting, as they are not intended for the assessment of safety (Safety Analysis Set).</desc>
      <group_list>
        <group group_id="E1">
          <title>AOHG MF</title>
          <description>All subjects exposed to AOHG MF</description>
        </group>
        <group group_id="E2">
          <title>DT1 MF</title>
          <description>All subjects exposed to DT1 MF</description>
        </group>
        <group group_id="E3">
          <title>DACP MF</title>
          <description>All subjects exposed to DACP MF</description>
        </group>
        <group group_id="E4">
          <title>PALs</title>
          <description>All subjects exposed to PALs</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </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>
    <limitations_and_caveats>Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sr. CDMA Project Lead, Vision Care</name_or_title>
      <organization>Alcon Research, LLC</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/NCT03757039
org study id: CLT792-P001
nct id: NCT03757039
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this trial was to compare the functional visual performance of Precision
      Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a
      presbyopic population.
Habitual contact lens wearers were randomized 1:1:1 to one of three commercially available
      multifocal contact lenses. Progressive addition lens wearers wore their habitual spectacles.
      Subjects were expected to attend 1 or 2 office visits. This study was terminated early by
      Alcon due to slow enrollment and inconsistency in measurement of the primary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This was a double-masked trial for the contact lens wearers. The PAL wearers were not masked.
measure: Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)
time frame: Day 1, after up to 3 hours of wear
description: The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.
arm group label: Multifocal Contact Lenses
arm group type: Experimental
description: Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon multifocal fitting guide. Lenses were worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
arm group label: PAL Spectacles
arm group type: Active Comparator
description: Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
intervention type: Device
intervention name: Multifocal soft contact lenses
description: Commercially available contact lenses
arm group label: Multifocal Contact Lenses
other name: DAILIES TOTAL1® Multifocal contact lenses (DT1 MF)
other name: DAILIES® AquaComfort Plus® Multifocal contact lenses (DACP MF)
other name: AIR OPTIX® plus HydraGlyde® Multifocal contact lenses (AOHG MF)
intervention type: Other
intervention name: Progressive addition lens spectacles
description: Per subject's habitual prescription
arm group label: PAL Spectacles
other name: PAL
criteria: 
gender: All
minimum age: 38 Years
maximum age: 58 Years
healthy volunteers: No
last name: Senior Clinical Manager, CDMA
role: Study Director
affiliation: Alcon Research, LLC
facility: 
facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised.
point of contact: 