<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/NCT03306641</url>
  </required_header>
  <id_info>
    <org_study_id>CV-17-29</org_study_id>
    <nct_id>NCT03306641</nct_id>
  </id_info>
  <brief_title>A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses</brief_title>
  <official_title>A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate the clinical performance of a new contact lens&#xD;
      design when worn over a period 1 week compared to nelfilcon A (control).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to validate the clinical performance of a new contact lens&#xD;
      design when worn over a period of 1 week compared to nelfilcon A (control). The primary&#xD;
      outcomes of interest is lens fit acceptance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>
    <intervention_model_description>This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Fit Acceptance</measure>
    <time_frame>1-Week</time_frame>
    <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Test Contact Lens</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test Contact Lens</intervention_name>
    <description>Daily disposable contact lens</description>
    <arm_group_label>Test Contact Lens</arm_group_label>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nelfilcon A</intervention_name>
    <description>Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
    <arm_group_label>Test Contact Lens</arm_group_label>
    <arm_group_label>nelfilcon A lens (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is at least 18 years of age and has full legal capacity to volunteer.&#xD;
&#xD;
          -  Is no greater than 55 years of age.&#xD;
&#xD;
          -  Has read and understood the information consent letter.&#xD;
&#xD;
          -  Is willing and able to follow instructions and maintain the appointment schedule.&#xD;
&#xD;
          -  Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks&#xD;
             prior to the study.&#xD;
&#xD;
          -  Has spectacle cylinder ≤1.00D in both eyes.&#xD;
&#xD;
          -  Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.&#xD;
&#xD;
          -  Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent&#xD;
             of 20/25 in each eye.&#xD;
&#xD;
          -  Wears CLs in both eyes (monvision acceptable, but not monofit)&#xD;
&#xD;
          -  Has clear corneas and no active ocular disease.&#xD;
&#xD;
          -  Has not worn lenses for at least 12 hours before the examination.&#xD;
&#xD;
          -  Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per&#xD;
             week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has never worn contact lenses before.&#xD;
&#xD;
          -  Has any systemic disease affecting ocular health.&#xD;
&#xD;
          -  Is using any systemic or topical medications that will affect ocular health.&#xD;
&#xD;
          -  Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to&#xD;
             severe dry eyes) that would affect the wearing of contact lenses.&#xD;
&#xD;
          -  Has persistent, clinically significant corneal or conjunctival staining using sodium&#xD;
             fluorescein dye.&#xD;
&#xD;
          -  Has any clinically significant lid or conjunctival abnormalities, active&#xD;
             neovascularization or any central corneal scars.&#xD;
&#xD;
          -  Is aphakic.&#xD;
&#xD;
          -  Has strabismus/amblyopia.&#xD;
&#xD;
          -  Has undergone corneal refractive surgery.&#xD;
&#xD;
          -  Is pregnant, lactating or planning a pregnancy.&#xD;
&#xD;
          -  Is participating in any concurrent clinical or research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <results_first_submitted>September 1, 2020</results_first_submitted>
  <results_first_submitted_qc>September 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2020</results_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03306641/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Contact Lens Then Nelfilcon A Lens (Control)</title>
          <description>Per randomized schedule, subject will wear a pair of the test lens for one week and then cross-over with the control pair for 1 week.&#xD;
Test Contact Lens: Daily disposable contact lens&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
        </group>
        <group group_id="P2">
          <title>Nelfilcon A Lens (Control) Then Test Contact Lens</title>
          <description>Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.&#xD;
Test Contact Lens: Daily disposable contact lens&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </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>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week.&#xD;
Test Contact Lens: Daily disposable contact lens&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" spread="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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit Acceptance</title>
        <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study.&#xD;
Test Contact Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study.&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.6"/>
                    <measurement group_id="O2" value="3.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Fit Acceptance</title>
        <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
        <time_frame>1-Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Contact Lens</title>
            <description>Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study.&#xD;
Test Contact Lens: Daily disposable contact lens</description>
          </group>
          <group group_id="O2">
            <title>Nelfilcon A Lens (Control)</title>
            <description>Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study.&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Fit Acceptance</title>
          <description>Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.6"/>
                    <measurement group_id="O2" value="3.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to 1-week on each pair of lenses, a total of two weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Contact Lens</title>
          <description>Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study.&#xD;
Test Contact Lens: Daily disposable contact lens</description>
        </group>
        <group group_id="E2">
          <title>Nelfilcon A Lens (Control)</title>
          <description>Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study.&#xD;
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)</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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lee Hall, BSc, PhD, MCOptom, FBCLA</name_or_title>
      <organization>CooperVision, Inc</organization>
      <phone>925 251 6684</phone>
      <email>lhall@coopervision.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/NCT03306641
org study id: CV-17-29
nct id: NCT03306641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period 1 week compared to nelfilcon A (control).
The purpose of this study is to validate the clinical performance of a new contact lens
      design when worn over a period of 1 week compared to nelfilcon A (control). The primary
      outcomes of interest is lens fit acceptance.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
measure: Lens Fit Acceptance
time frame: Baseline
description: Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
measure: Lens Fit Acceptance
time frame: 1-Week
description: Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
arm group label: Test Contact Lens
arm group type: Active Comparator
description: Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
arm group label: nelfilcon A lens (control)
arm group type: Active Comparator
description: Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.
intervention type: Device
intervention name: Test Contact Lens
description: Daily disposable contact lens
arm group label: Test Contact Lens
arm group label: nelfilcon A lens (control)
intervention type: Device
intervention name: Nelfilcon A
description: Focus Dailies All Day Comfort contact lens (nelfilcon A)
arm group label: Test Contact Lens
arm group label: nelfilcon A lens (control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 