<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/NCT02212301</url>
  </required_header>
  <id_info>
    <org_study_id>CR-5573</org_study_id>
    <nct_id>NCT02212301</nct_id>
  </id_info>
  <brief_title>Comparison of Two Marketed Lenses in a Controlled Environment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Vision Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Vision Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is comparing two silicone hydrogel contact lenses in a controlled environment for&#xD;
      identification of characteristics associated to vision.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear Film Kinetics</measure>
    <time_frame>8 hour post insertion</time_frame>
    <description>The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Controlled Visual Acuity</measure>
    <time_frame>8 hours post insertion</time_frame>
    <description>The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17&quot; LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3&quot; LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Eye Dryness</condition>
  <arm_group>
    <arm_group_label>senofilcon A / lotrafilcon B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens and then wore the lotrafilcon B contact lens.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lotrafilon B/ senofilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the lotrafilcon B contact lens and then wore the senofilcon A contact lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>senofilcon A</intervention_name>
    <description>Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.</description>
    <arm_group_label>lotrafilon B/ senofilcon A</arm_group_label>
    <arm_group_label>senofilcon A / lotrafilcon B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lotrafilcon B</intervention_name>
    <description>Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.</description>
    <arm_group_label>lotrafilon B/ senofilcon A</arm_group_label>
    <arm_group_label>senofilcon A / lotrafilcon B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject must be 18 years of age and less than 51 years of age;&#xD;
&#xD;
          2. The subject must have read and understood the Participant Information Sheet;&#xD;
&#xD;
          3. The subject must have read, signed and dated the Informed Consent;&#xD;
&#xD;
          4. The subject must be a current planned replacement soft contact lens wearer;&#xD;
&#xD;
          5. The subject must be a regular user of devices (computer, tablet and/or smart phone)&#xD;
             for a minimum average of 5 ± 1 hours per day in a typical week&#xD;
&#xD;
          6. The subject must have a refractive error within the range of correction of both study&#xD;
             contact lenses;&#xD;
&#xD;
          7. The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or&#xD;
             better in each eye;&#xD;
&#xD;
          8. The subject must demonstrate an acceptable fit with both study contact lenses;&#xD;
&#xD;
          9. The subject must agree to wear their contact lenses as directed for the duration of&#xD;
             the study (every day or for at least a minimum of five days per week for a minimum of&#xD;
             six hours per day and be willing and able to adhere to the instructions set in the&#xD;
             clinical protocol and maintain the appointment schedule;&#xD;
&#xD;
         10. The subject must have normal eyes with the exception of the need for visual&#xD;
             correction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known sensitivity or intolerance to any of the contact lenses or adjunct products&#xD;
             to be used.&#xD;
&#xD;
          2. Monocular vision (only one eye with functional vision or only one eye fitted with&#xD;
             contact lenses).&#xD;
&#xD;
          3. Use of systemic or ocular concomitant medications which, as determined by the&#xD;
             investigator, might contraindicate or interfere with contact lens wear.&#xD;
&#xD;
          4. Ocular anterior segment infection, inflammation, abnormality, or active disease, which&#xD;
             would contraindicate contact lens wear.&#xD;
&#xD;
          5. Any moderate or severe ocular condition observed during slit lamp examination at the&#xD;
             enrollment visit.&#xD;
&#xD;
          6. A history of herpetic keratitis, ocular surgery or irregular cornea(s).&#xD;
&#xD;
          7. Known pregnancy or lactation during the study period.&#xD;
&#xD;
          8. Enrollment of investigator's office staff, relatives, or members of their respective&#xD;
             households.&#xD;
&#xD;
          9. Participation in any clinical trial within 30 days of the enrollment visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>SW1E 6AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>August 4, 2016</results_first_submitted>
  <results_first_submitted_qc>August 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 27, 2016</results_first_posted>
  <last_update_submitted>September 26, 2016</last_update_submitted>
  <last_update_submitted_qc>September 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 45 subjects were enrolled into this study. Of the enrolled subjects 43 were dispensed and 2 subjects did not meet the eligibility criteria. Of the 43 dispensed subjects, 1 subject was discontinued 42 subjects completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Senofilcon A/ Lotrafilcon B</title>
          <description>Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.</description>
        </group>
        <group group_id="P2">
          <title>Lotrafilcon B / Senofilcon A</title>
          <description>Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </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>All subjects that were dispensed at least one study lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Dispensed Subjects</title>
          <description>All subjects that were dispensed at least one lens throughout the duration of the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </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="35.1" spread="7.78"/>
                  </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="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tear Film Kinetics</title>
        <description>The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.</description>
        <time_frame>8 hour post insertion</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A</title>
            <description>Subjects that received the senofilcon A contact lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Film Kinetics</title>
          <description>The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.</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="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.590" spread="4.2705"/>
                    <measurement group_id="O2" value="6.941" spread="6.1257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time Controlled Visual Acuity</title>
        <description>The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17&quot; LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3&quot; LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.</description>
        <time_frame>8 hours post insertion</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A</title>
            <description>Subjects that received the senofilcon A contact lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Controlled Visual Acuity</title>
          <description>The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17&quot; LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3&quot; LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Distance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.092"/>
                    <measurement group_id="O2" value="-0.07" spread="0.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.077"/>
                    <measurement group_id="O2" value="0.06" spread="0.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study. Approximately 1 month per subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Senofilcon A</title>
          <description>Subjects that received the senofilcon A contact lens in either the first or second period of the study.</description>
        </group>
        <group group_id="E2">
          <title>Lotrafilcon B</title>
          <description>Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </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="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <description>Non-ocular adverse event</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="43"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tawnya Wilson OD</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care Inc.</organization>
      <phone>904-443-3500 ext 1834</phone>
      <email>TWilson@ITS.JNJ.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/NCT02212301
org study id: CR-5573
nct id: NCT02212301
lead sponsor: 
has dmc: No
This study is comparing two silicone hydrogel contact lenses in a controlled environment for
      identification of characteristics associated to vision.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Tear Film Kinetics
time frame: 8 hour post insertion
description: The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.
measure: Time Controlled Visual Acuity
time frame: 8 hours post insertion
description: The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.
arm group label: senofilcon A / lotrafilcon B
arm group type: Active Comparator
description: Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens and then wore the lotrafilcon B contact lens.
arm group label: lotrafilon B/ senofilcon A
arm group type: Active Comparator
description: Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the lotrafilcon B contact lens and then wore the senofilcon A contact lens
intervention type: Device
intervention name: senofilcon A
description: Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
arm group label: lotrafilon B/ senofilcon A
arm group label: senofilcon A / lotrafilcon B
intervention type: Device
intervention name: lotrafilcon B
description: Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
arm group label: lotrafilon B/ senofilcon A
arm group label: senofilcon A / lotrafilcon B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 