<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/NCT02970799</url>
  </required_header>
  <id_info>
    <org_study_id>OCUN-016B</org_study_id>
    <nct_id>NCT02970799</nct_id>
  </id_info>
  <brief_title>Tear Production by Nasal Neurostimulation Compared to Active Control</brief_title>
  <official_title>Randomized, Controlled, Crossover Study Comparing Tear Production by Nasal Neurostimulation Versus Active Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oculeve, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oculeve, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This crossover design study evaluates the effectiveness of the Oculeve Intranasal&#xD;
      Neurostimulator comparing the effect of intranasal (active) versus extranasal (control)&#xD;
      stimulation on tear production as measured by the Jones Schirmer test in participants with&#xD;
      dry eye disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized, controlled study, participants will receive two applications of&#xD;
      approximately a three-minute duration, one intranasal (active) and one extranasal (control),&#xD;
      in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants&#xD;
      will undergo two applications of approximately an eight-minute duration, one intranasal&#xD;
      (active) and one extranasal (control), in randomized sequence. The Schirmer test is a&#xD;
      clinically relevant and accepted measure to assess tear production over a specified time&#xD;
      interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear&#xD;
      meniscus area (TMA) have been reported as measures of tear quantity and/or production and&#xD;
      have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA&#xD;
      is via use of optical coherence tomography (OCT), an established medical imaging technique&#xD;
      that uses light to capture micrometer-resolution images from within optical scattering media&#xD;
      such as biological tissue. Due to the non-invasive nature of the technique, this study was&#xD;
      designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating&#xD;
      stimulated tear production following use of the study device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2016</start_date>
  <completion_date type="Actual">October 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Tear Production by Jones Schirmer Test</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Tear Meniscus Height</measure>
    <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Tear Meniscus Area</measure>
    <time_frame>Pre and Post Application Days 15 and 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Secreting Meibomian Glands</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Tear Film Lipid Layer Thickness by Tearscope</measure>
    <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lower Lid Margin Temperature</measure>
    <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Tear Film Temperature</measure>
    <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Up to 41 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Dry Eye</condition>
  <condition>Dry Eye Syndromes</condition>
  <condition>Keratoconjunctivitis Sicca</condition>
  <arm_group>
    <arm_group_label>Intranasal then Extranasal Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extranasal then Intranasal Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intranasal Neurostimulator</intervention_name>
    <description>The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.</description>
    <arm_group_label>Extranasal then Intranasal Application</arm_group_label>
    <arm_group_label>Intranasal then Extranasal Application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to severe dry eye disease&#xD;
&#xD;
          -  Have not worn contact lenses for at least seven days prior to the Screening Visit and&#xD;
             willing to forego the use of contact lenses for the duration of the study&#xD;
&#xD;
          -  Literate, able to speak English or Spanish, and able to complete questionnaires&#xD;
             independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously used the Intranasal Neurostimulator at any time&#xD;
&#xD;
          -  Used commercial lid hygiene product within 14 days of the Screening Visit or plan to&#xD;
             use at any time during the study&#xD;
&#xD;
          -  Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the&#xD;
             opinion of the investigator, may lead to the risk of clinically significant increased&#xD;
             bleeding&#xD;
&#xD;
          -  Nasal or sinus surgery (including history of application of nasal cautery) or&#xD;
             significant trauma to these areas&#xD;
&#xD;
          -  Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate&#xD;
             hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the&#xD;
             Screening Visit&#xD;
&#xD;
          -  Have an implanted metallic or other electronic device in the head, a cardiac demand&#xD;
             pacemaker, or an implanted defibrillator&#xD;
&#xD;
          -  Participation in any clinical trial with a new active substance or a new device within&#xD;
             30 days of the Screening Visit&#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>Gail Torkildsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andover Eye Associates</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>September 22, 2021</results_first_submitted>
  <results_first_submitted_qc>September 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2021</results_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Keratoconjunctivitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intranasal Then Extranasal Application</title>
          <description>Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.</description>
        </group>
        <group group_id="P2">
          <title>Extranasal Then Intranasal Application</title>
          <description>Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </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="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
      <group_list>
        <group group_id="B1">
          <title>Intranasal Then Extranasal Application</title>
          <description>Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.</description>
        </group>
        <group group_id="B2">
          <title>Extranasal Then Intranasal Application</title>
          <description>Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>participants</units>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acute Tear Production by Jones Schirmer Test</title>
        <time_frame>Day 1</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Tear Production by Jones Schirmer Test</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tear Meniscus Height</title>
        <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Meniscus Height</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tear Meniscus Area</title>
        <time_frame>Pre and Post Application Days 15 and 29</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Meniscus Area</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Secreting Meibomian Glands</title>
        <time_frame>Day 1</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Secreting Meibomian Glands</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tear Film Lipid Layer Thickness by Tearscope</title>
        <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Film Lipid Layer Thickness by Tearscope</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Lower Lid Margin Temperature</title>
        <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Lower Lid Margin Temperature</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tear Film Temperature</title>
        <time_frame>Pre and Post Application on Days 15 and 29</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Film Temperature</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Adverse Events</title>
        <time_frame>Up to 41 days</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Intranasal Application</title>
            <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
          </group>
          <group group_id="O2">
            <title>Extranasal Application</title>
            <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intranasal Application</title>
          <description>Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29.</description>
        </group>
        <group group_id="E2">
          <title>Extranasal Application</title>
          <description>Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor and Ora will have the final decision regarding the manuscript and publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT02970799
org study id: OCUN-016B
nct id: NCT02970799
lead sponsor: 
has dmc: No
is fda regulated device: Yes
This crossover design study evaluates the effectiveness of the Oculeve Intranasal
      Neurostimulator comparing the effect of intranasal (active) versus extranasal (control)
      stimulation on tear production as measured by the Jones Schirmer test in participants with
      dry eye disease.
In this randomized, controlled study, participants will receive two applications of
      approximately a three-minute duration, one intranasal (active) and one extranasal (control),
      in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants
      will undergo two applications of approximately an eight-minute duration, one intranasal
      (active) and one extranasal (control), in randomized sequence. The Schirmer test is a
      clinically relevant and accepted measure to assess tear production over a specified time
      interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear
      meniscus area (TMA) have been reported as measures of tear quantity and/or production and
      have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA
      is via use of optical coherence tomography (OCT), an established medical imaging technique
      that uses light to capture micrometer-resolution images from within optical scattering media
      such as biological tissue. Due to the non-invasive nature of the technique, this study was
      designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating
      stimulated tear production following use of the study device.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Acute Tear Production by Jones Schirmer Test
time frame: Day 1
measure: Tear Meniscus Height
time frame: Pre and Post Application on Days 15 and 29
measure: Tear Meniscus Area
time frame: Pre and Post Application Days 15 and 29
measure: Number of Secreting Meibomian Glands
time frame: Day 1
measure: Tear Film Lipid Layer Thickness by Tearscope
time frame: Pre and Post Application on Days 15 and 29
measure: Lower Lid Margin Temperature
time frame: Pre and Post Application on Days 15 and 29
measure: Tear Film Temperature
time frame: Pre and Post Application on Days 15 and 29
measure: Number of Participants With Adverse Events
time frame: Up to 41 days
arm group label: Intranasal then Extranasal Application
arm group type: Experimental
description: Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
arm group label: Extranasal then Intranasal Application
arm group type: Experimental
description: Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.
intervention type: Device
intervention name: Intranasal Neurostimulator
description: The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
arm group label: Extranasal then Intranasal Application
arm group label: Intranasal then Extranasal Application
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Gail Torkildsen, MD
role: Principal Investigator
affiliation: Andover Eye Associates
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Keratoconjunctivitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
point of contact: 