<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/NCT04500821</url>
  </required_header>
  <id_info>
    <org_study_id>DRYE-105-ACTS</org_study_id>
    <nct_id>NCT04500821</nct_id>
  </id_info>
  <brief_title>Evaluation of the LipiFlow System With a New Activator</brief_title>
  <official_title>Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Surgical Vision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Surgical Vision, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical&#xD;
      study. The investigator or designee will perform LipiFlow treatment with the Activators&#xD;
      LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the&#xD;
      LipiFlow console and from the questionnaire will be used to assess the clinical utilization&#xD;
      of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful Completion of LipiFlow Treatment With Activator LFD-2100</measure>
    <time_frame>1 day after completion of LipiFlow treatment</time_frame>
    <description>Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>Activator LFD-2100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activator LFD-2100</intervention_name>
    <description>LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD</description>
    <arm_group_label>Activator LFD-2100</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be able to participate in this study, subjects must:&#xD;
&#xD;
          -  Be at least 22 years old.&#xD;
&#xD;
          -  Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD&#xD;
             in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator&#xD;
             opinion or based on assessment of meibomian glands of the lower eyelid.&#xD;
&#xD;
          -  Availability, willingness, ability and sufficient cognitive awareness to comply with&#xD;
             study protocol, examination procedures and visit.&#xD;
&#xD;
          -  Be willing to provide informed consent and authorization to disclose protected health&#xD;
             information or equivalent documentation necessary to comply with applicable privacy&#xD;
             laws pertaining to medical procedures.&#xD;
&#xD;
          -  Ability to understand and respond in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subject will not be able to be in the study, if the subject:&#xD;
&#xD;
          -  Has a history of certain medical conditions that have been identified as&#xD;
             contraindications and precautions of the LipiFlow System&#xD;
&#xD;
          -  Has a history of prior eye surgery or trauma, active eye disease, or other eye&#xD;
             abnormality in the study eye(s), which in the opinion of the investigator would&#xD;
             confound the study results.&#xD;
&#xD;
          -  Is pregnant, or is breast feeding.&#xD;
&#xD;
          -  Concurrent participation or expected participation in an interventional (i.e.,&#xD;
             surgical or pharmaceutical interventional) clinical trial within 14 days prior to&#xD;
             study screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Surgical Vision Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Surgical vision</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Empire Eye and Laser Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Eye Research Center</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <results_first_submitted>October 18, 2021</results_first_submitted>
  <results_first_submitted_qc>January 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 24, 2022</results_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2022</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>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Johnson &amp; Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu</ipd_description>
    <ipd_url>http://yoda.yale.edu</ipd_url>
  </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>August 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04500821/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>September 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04500821/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 88 eyes of 44 subjects with meibomian gland dysfunction were enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Activator LFD-2100</title>
          <description>Lipiflow treatment with Activator LFD-2100</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Activator LFD-2100</title>
          <description>Lipiflow treatment with Activator LFD-2100</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Sex</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Successful Completion of LipiFlow Treatment With Activator LFD-2100</title>
        <description>Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100</description>
        <time_frame>1 day after completion of LipiFlow treatment</time_frame>
        <population>All treated eyes</population>
        <group_list>
          <group group_id="O1">
            <title>Activator LFD-2100</title>
            <description>LipiFlow treatment with Activator LFD-2100</description>
          </group>
        </group_list>
        <measure>
          <title>Successful Completion of LipiFlow Treatment With Activator LFD-2100</title>
          <description>Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100</description>
          <population>All treated eyes</population>
          <units>Percent of eyes</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the course of the study until completion, 1 up to 2 days.</time_frame>
      <desc>Analysis population include all eyes (88 eyes) of 44 participants treated with Lipiflow with Activator LFD-2100. All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for each eye separately.</desc>
      <group_list>
        <group group_id="E1">
          <title>Right Eye (OD)</title>
          <description>LipiFlow treatment with Activator LFD-2100</description>
        </group>
        <group group_id="E2">
          <title>Left Eye (OS)</title>
          <description>LipiFlow treatment with Activator LFD-2100</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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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 sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Luis Vargas, MD</name_or_title>
      <organization>Johnson &amp; Johnson Surgical Vision</organization>
      <phone>714-247-8200</phone>
      <email>LVarga17@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/NCT04500821
org study id: DRYE-105-ACTS
nct id: NCT04500821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical
      study. The investigator or designee will perform LipiFlow treatment with the Activators
      LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the
      LipiFlow console and from the questionnaire will be used to assess the clinical utilization
      of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful Completion of LipiFlow Treatment With Activator LFD-2100
time frame: 1 day after completion of LipiFlow treatment
description: Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
arm group label: Activator LFD-2100
arm group type: Experimental
description: LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
intervention type: Device
intervention name: Activator LFD-2100
description: LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
arm group label: Activator LFD-2100
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Johnson & Johnson Surgical Vision Clinical Trials
role: Study Director
affiliation: Johnson & Johnson Surgical vision
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Meibomian Gland Dysfunction
sharing ipd: Yes
ipd description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
ipd url: http://yoda.yale.edu
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 