<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/NCT03787212</url>
  </required_header>
  <id_info>
    <org_study_id>CR-6281</org_study_id>
    <nct_id>NCT03787212</nct_id>
  </id_info>
  <brief_title>MiBo ThermoFlo Lid Temperature Evaluation</brief_title>
  <official_title>MiBo ThermoFlo Lid Temperature Evaluation</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of&#xD;
      external and internal eyelid temperature after treatment with the MiBo ThermoFlo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated due to safety assessment of the study product&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">January 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posterior Eyelid Temperature (Palpebral Conjunctiva)</measure>
    <time_frame>12-minutes post treatment</time_frame>
    <description>Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of &gt;40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>MiBo ThermoFlo / Bruder mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bruder Mask / MiBo ThermoFlo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MiBo ThermoFlo</intervention_name>
    <description>Test Device</description>
    <arm_group_label>Bruder Mask / MiBo ThermoFlo</arm_group_label>
    <arm_group_label>MiBo ThermoFlo / Bruder mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bruder Mask</intervention_name>
    <description>Control Device</description>
    <arm_group_label>Bruder Mask / MiBo ThermoFlo</arm_group_label>
    <arm_group_label>MiBo ThermoFlo / Bruder mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must satisfy all the following criteria to be enrolled in the&#xD;
             study:&#xD;
&#xD;
               1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and&#xD;
                  receive a fully executed copy of the form.&#xD;
&#xD;
               2. Appear able and willing to adhere to the instructions set forth in this clinical&#xD;
                  protocol.&#xD;
&#xD;
               3. Between 18 and 80 (inclusive) years of age at the time of screening.&#xD;
&#xD;
               4. Subjects must possess a functional/usable pair of spectacles and bring them to&#xD;
                  the visit (only if applicable - to the investigators discretion).&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects who meet any of the following criteria will be excluded from&#xD;
             participating in the study:&#xD;
&#xD;
               1. Currently pregnant or breastfeeding.&#xD;
&#xD;
               2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease&#xD;
                  (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g.,&#xD;
                  HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by&#xD;
                  self-report, which are known to interfere with participation in the study.&#xD;
&#xD;
               3. Clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp&#xD;
                  findings (e.g. corneal edema, neovascularization or staining, tarsal&#xD;
                  abnormalities or bulbar injection).&#xD;
&#xD;
               4. Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading&#xD;
                  scale.&#xD;
&#xD;
               5. Any active Ocular Infection or Inflammation&#xD;
&#xD;
               6. Any history of eyelid surgery or abnormality&#xD;
&#xD;
               7. History of Metal Implants in the Eyelids&#xD;
&#xD;
               8. Any known hypersensitivity or allergic reaction to ultrasound coupling gel.&#xD;
&#xD;
               9. LASIK Surgery within 2 weeks of the Baseline Visit.&#xD;
&#xD;
              10. Participation in any contact lens or lens care product clinical trial within 14&#xD;
                  days prior to study enrollment.&#xD;
&#xD;
              11. History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.&#xD;
&#xD;
              12. Employee or immediate family member of an employee of clinical site (e.g.,&#xD;
                  Investigator, Coordinator, Technician).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Houston, College of Optometry</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>January 17, 2020</results_first_submitted>
  <results_first_submitted_qc>January 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>Dry Eye Syndromes</mesh_term>
  </condition_browse>
  <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>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03787212/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 4 subjects were enrolled into this study prior to its termination. This study was terminated early by the sponsor due to a warning letter from the FDA regarding non-compliance to 21 CFR part 820.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Test/Control</title>
          <description>Subjects randomized to this sequence received the MiBo ThermoFlo as Test in their left eye and then received the Bruder Moist Heat Single Eye Compress as Control in their right eye.</description>
        </group>
        <group group_id="P2">
          <title>Control/Test</title>
          <description>Subjects randomized to this sequence received the Bruder Moist Heat Single Eye Compress as Control in their left eye and then received the MiBo ThermoFlo as Test in their right eye</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Enrolled Subjects</title>
          <description>All subjects enrolled into the study prior to early study termination.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </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="29.25" spread="7.847"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Count of Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Posterior Eyelid Temperature (Palpebral Conjunctiva)</title>
        <description>Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of &gt;40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.</description>
        <time_frame>12-minutes post treatment</time_frame>
        <population>All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that recieved the Test treatment during any point in this study</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that recieved the Control treatment at any point during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Posterior Eyelid Temperature (Palpebral Conjunctiva)</title>
          <description>Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of &gt;40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.</description>
          <population>All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.</population>
          <units>Celcius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left Eye - Lower Lid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.835" spread="0.9829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Eye - Upper Lid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.545" spread="0.1485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Eye - Lower Lid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.42" spread="0"/>
                    <measurement group_id="O2" value="37.415" spread="0.5162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Eye - Upper Lid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.77" spread="0"/>
                    <measurement group_id="O2" value="37.19" spread="0.1131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the entire duration of the study. Approximately 1 day per subject, due to early study Termination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Subjects that recieved the Test treatment during any point in this study</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Subjects that recieved the Control treatment at any point during the study.</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was discontinued by the sponsor, due to the manufacturer of the MiBo ThermoFlo receiving a warning letter from the FDA regarding non-compliance to 21 CFR part 820. Subsequently, the primary analyses were not carried.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chantal Coles-Brennan, OD - Principal Research Optometrist</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care Inc.</organization>
      <phone>904 443 3449</phone>
      <email>CColesb@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/NCT03787212
org study id: CR-6281
nct id: NCT03787212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of
      external and internal eyelid temperature after treatment with the MiBo ThermoFlo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Posterior Eyelid Temperature (Palpebral Conjunctiva)
time frame: 12-minutes post treatment
description: Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of >40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.
arm group label: MiBo ThermoFlo / Bruder mask
arm group type: Experimental
description: Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
arm group label: Bruder Mask / MiBo ThermoFlo
arm group type: Experimental
description: Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
intervention type: Device
intervention name: MiBo ThermoFlo
description: Test Device
arm group label: Bruder Mask / MiBo ThermoFlo
arm group label: MiBo ThermoFlo / Bruder mask
intervention type: Device
intervention name: Bruder Mask
description: Control Device
arm group label: Bruder Mask / MiBo ThermoFlo
arm group label: MiBo ThermoFlo / Bruder mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was discontinued by the sponsor, due to the manufacturer of the MiBo ThermoFlo receiving a warning letter from the FDA regarding non-compliance to 21 CFR part 820. Subsequently, the primary analyses were not carried.
point of contact: 