<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/NCT02252133</url>
  </required_header>
  <id_info>
    <org_study_id>ALJ-V2014-1</org_study_id>
    <nct_id>NCT02252133</nct_id>
  </id_info>
  <brief_title>DAILIES TOTAL1® Lens Centration in a Japanese Population</brief_title>
  <official_title>Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population</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 compare the lens centration of DAILIES TOTAL1® (DT1) contact&#xD;
      lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2&#xD;
      days of wearing of each product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate of Lens Centration After 7 ± 2 Days of Wear</measure>
    <time_frame>Day 7, each product</time_frame>
    <description>Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as &quot;optimal&quot; or &quot;slight decentration. One eye (study eye) was analyzed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Myopia</condition>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>DT1, then 1DAVTE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1DAVTE, then DT1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Delefilcon A contact lenses</intervention_name>
    <description>Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear</description>
    <arm_group_label>1DAVTE, then DT1</arm_group_label>
    <arm_group_label>DT1, then 1DAVTE</arm_group_label>
    <other_name>DAILIES TOTAL1®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Narafilcon A contact lenses</intervention_name>
    <description>Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear</description>
    <arm_group_label>1DAVTE, then DT1</arm_group_label>
    <arm_group_label>DT1, then 1DAVTE</arm_group_label>
    <other_name>1-DAY ACUVUE® TruEye®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign Informed Consent document.&#xD;
&#xD;
          -  Habitually wear soft contact lenses on a daily disposable or weekly/monthly&#xD;
             replacement basis.&#xD;
&#xD;
          -  Symptoms of contact lens discomfort as defined by protocol.&#xD;
&#xD;
          -  Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.&#xD;
&#xD;
          -  Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.&#xD;
&#xD;
          -  Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with&#xD;
             pre-study lenses at Visit 1.&#xD;
&#xD;
          -  Acceptable contact lens fit with both study contact lenses.&#xD;
&#xD;
          -  Willing to wear lenses every day for at least for a minimum of five days per week six&#xD;
             hours per day, every day if possible and attend all study visits.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently wearing DT1 or 1DAVTE.&#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 twelve weeks immediately prior to enrollment for this&#xD;
             trial.&#xD;
&#xD;
          -  Any moderate or severe ocular condition observed during the slit-lamp 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 subjects (only one eye with functional vision) or subjects fit with only one&#xD;
             lens.&#xD;
&#xD;
          -  Judged ineligible as a patient in this clinical study by the investigator.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Manager, Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Japan, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Contact Alcon Japan Ltd. for Trial Locations</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>November 19, 2015</results_first_submitted>
  <results_first_submitted_qc>November 19, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 28, 2015</results_first_posted>
  <last_update_submitted>December 24, 2015</last_update_submitted>
  <last_update_submitted_qc>December 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contact lenses</keyword>
  <keyword>Myopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 3 study centers located in Japan.</recruitment_details>
      <pre_assignment_details>Of the 53 enrolled, 6 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (47).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DT1, Then 1DAVTE</title>
          <description>Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.</description>
        </group>
        <group group_id="P2">
          <title>1DAVTE, Then DT1</title>
          <description>Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </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>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </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 group includes all randomized subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
          </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="37.0" spread="9.6"/>
                  </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="37"/>
                  </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>Success Rate of Lens Centration After 7 ± 2 Days of Wear</title>
        <description>Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as &quot;optimal&quot; or &quot;slight decentration. One eye (study eye) was analyzed.</description>
        <time_frame>Day 7, each product</time_frame>
        <population>This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Dailies Total 1</title>
            <description>Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>1DAVTE</title>
            <description>Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of Lens Centration After 7 ± 2 Days of Wear</title>
          <description>Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as &quot;optimal&quot; or &quot;slight decentration. One eye (study eye) was analyzed.</description>
          <population>This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="86.7"/>
                  </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 14 days). AEs were obtained through use of a subjective questionnaire.</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 investigational medical device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dailies Total 1</title>
          <description>All subjects who wore delefilcon A contact lenses</description>
        </group>
        <group group_id="E2">
          <title>1DAVTE</title>
          <description>All subjects who wore narafilcon A 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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </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>Senior Manager, Clinical Development, Japan</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/NCT02252133
org study id: ALJ-V2014-1
nct id: NCT02252133
lead sponsor: 
has dmc: No
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact
      lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2
      days of wearing of each product.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Success Rate of Lens Centration After 7 ± 2 Days of Wear
time frame: Day 7, each product
description: Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.
arm group label: DT1, then 1DAVTE
arm group type: Other
description: Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
arm group label: 1DAVTE, then DT1
arm group type: Other
description: Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
intervention type: Device
intervention name: Delefilcon A contact lenses
description: Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
arm group label: 1DAVTE, then DT1
arm group label: DT1, then 1DAVTE
other name: DAILIES TOTAL1®
intervention type: Device
intervention name: Narafilcon A contact lenses
description: Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear
arm group label: 1DAVTE, then DT1
arm group label: DT1, then 1DAVTE
other name: 1-DAY ACUVUE® TruEye®
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Manager, Clinical Development
role: Study Director
affiliation: Alcon Japan, Ltd.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Myopia
mesh term: Refractive Errors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 