<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/NCT01710787</url>
  </required_header>
  <id_info>
    <org_study_id>SR 3-02</org_study_id>
    <nct_id>NCT01710787</nct_id>
  </id_info>
  <brief_title>Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth in Adults</brief_title>
  <official_title>A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Renatus, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Triligent International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rho, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Renatus, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and&#xD;
      Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will employ a multi-center, randomized, double-blind, placebo-controlled,&#xD;
      parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered&#xD;
      intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary&#xD;
      right second premolar to maxillary left second premolar) sufficient to allow completion of&#xD;
      the Study Dental Procedure.&#xD;
&#xD;
      The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study&#xD;
      sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated&#xD;
      with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo.&#xD;
      Recruitment will be from diverse dental patient populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.</measure>
    <time_frame>at 15 minutes with a 3 minute window</time_frame>
    <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoral Soft-tissue Anesthesia (Yes/no)</measure>
    <time_frame>at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window</time_frame>
    <description>Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Heart Rate Higher Than 125 Bpm</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Heart Rate Lower Than 50 Bpm</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg</measure>
    <time_frame>at any time within 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Maximum Change From Baseline in Heart Rate</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Maximum Change From Baseline in Systolic Blood Pressure</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Maximum Change From Baseline in Diastolic Blood Pressure</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Profile Over Time of Heart Rate</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Profile Over Time of Systolic Blood Pressure</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Profile Over Time of Diastolic Blood Pressure</measure>
    <time_frame>from baseline to 120 minutes following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Sniff Test</measure>
    <time_frame>administered at baseline, 120 minutes and approximately 24 hours after drug administration</time_frame>
    <description>The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoral Soft-tissue Anesthesia (Onset and Duration)</measure>
    <time_frame>up to 120 mins post-dose</time_frame>
    <description>Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Kovacaine Mist, 3 sprays unilateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tetracaine Only, 3 sprays unilateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tetracaine HCl 3%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, 3 sprays unilateral</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%</intervention_name>
    <description>3 unilateral intranasal sprays per dose</description>
    <arm_group_label>Kovacaine Mist, 3 sprays unilateral</arm_group_label>
    <other_name>Kovacaine Mist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tetracaine HCl 3%</intervention_name>
    <description>3 unilateral intranasal sprays per dose</description>
    <arm_group_label>Tetracaine Only, 3 sprays unilateral</arm_group_label>
    <other_name>Active control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 unilateral intranasal sprays per dose</description>
    <arm_group_label>Placebo, 3 sprays unilateral</arm_group_label>
    <other_name>Inactive ingredients</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 years of age or older.&#xD;
&#xD;
          -  Need for an operative restorative dental procedure requiring local anesthesia for a&#xD;
             single vital maxillary tooth (other than a maxillary first, second, or third molar)&#xD;
             with no evidence of pulpal pathology.&#xD;
&#xD;
          -  Normal lip, nose, eyelid, and cheek sensation.&#xD;
&#xD;
          -  Able to understand and sign the study informed consent document, communicate with the&#xD;
             investigators, and understand and comply with the requirements of the protocol.&#xD;
&#xD;
          -  Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.&#xD;
&#xD;
          -  Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.&#xD;
&#xD;
          -  Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated&#xD;
             diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).&#xD;
&#xD;
          -  Inadequately controlled active thyroid disease of any type.&#xD;
&#xD;
          -  Frequent nose bleeds (≥ 5 per month).&#xD;
&#xD;
          -  Having received dental care requiring a local anesthetic within the last 24 hours.&#xD;
&#xD;
          -  History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local&#xD;
             anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).&#xD;
&#xD;
          -  History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or&#xD;
             sulfite preservatives.&#xD;
&#xD;
          -  Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.&#xD;
&#xD;
          -  Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females&#xD;
             of child-bearing potential will be required to take a urine pregnancy test on the day&#xD;
             of, but prior to, study drug administration to rule out pregnancy.)&#xD;
&#xD;
          -  Having received any investigational drug and/or participation in any clinical trial&#xD;
             within 30 days prior to study participation.&#xD;
&#xD;
          -  Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other&#xD;
             nasal or oral decongestant on the day of the study procedure.&#xD;
&#xD;
          -  History of congenital or idiopathic methemoglobinemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A. Moore, DMD/PhD/MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14214-8004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family and Cosmetic Dentistry</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>October 6, 2016</results_first_submitted>
  <results_first_submitted_qc>July 28, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2017</results_first_posted>
  <disposition_first_submitted>May 15, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 15, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 8, 2015</disposition_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>operative</keyword>
  <keyword>dental procedure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Tetracaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Kovacaine Mist, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="P2">
          <title>Tetracaine Only, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="P3">
          <title>Placebo, 3 Sprays Unilateral</title>
          <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</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 group_id="P2" count="44"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Kovacaine Mist, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="B2">
          <title>Tetracaine Only, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="B3">
          <title>Placebo, 3 Sprays Unilateral</title>
          <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="B4">
          <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="44"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="110"/>
          </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="37.1" spread="14.73"/>
                    <measurement group_id="B2" value="31.3" spread="12.01"/>
                    <measurement group_id="B3" value="35.7" spread="14.64"/>
                    <measurement group_id="B4" value="34.5" spread="13.82"/>
                  </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="30"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.</title>
        <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
        <time_frame>at 15 minutes with a 3 minute window</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.</title>
          <description>If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.1" lower_limit="69.9" upper_limit="93.4"/>
                    <measurement group_id="O2" value="27.3" lower_limit="15" upper_limit="42.8"/>
                    <measurement group_id="O3" value="27.3" lower_limit="10.7" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoral Soft-tissue Anesthesia (Yes/no)</title>
        <description>Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints</description>
        <time_frame>at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window</time_frame>
        <population>Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.</population>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoral Soft-tissue Anesthesia (Yes/no)</title>
          <description>Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints</description>
          <population>Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Heart Rate Higher Than 125 Bpm</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Heart Rate Higher Than 125 Bpm</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Heart Rate Lower Than 50 Bpm</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Heart Rate Lower Than 50 Bpm</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg</title>
        <time_frame>at any time within 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Maximum Change From Baseline in Heart Rate</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Maximum Change From Baseline in Heart Rate</title>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="11.53"/>
                    <measurement group_id="O2" value="10.5" spread="10.74"/>
                    <measurement group_id="O3" value="7.0" spread="7.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Maximum Change From Baseline in Systolic Blood Pressure</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Maximum Change From Baseline in Systolic Blood Pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="10.74"/>
                    <measurement group_id="O2" value="10.8" spread="9.15"/>
                    <measurement group_id="O3" value="5.1" spread="9.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Maximum Change From Baseline in Diastolic Blood Pressure</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Maximum Change From Baseline in Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="7.12"/>
                    <measurement group_id="O2" value="7.3" spread="4.96"/>
                    <measurement group_id="O3" value="6.7" spread="4.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Profile Over Time of Heart Rate</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>The Profile Over Time of Heart Rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Study (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5" spread="13.10"/>
                    <measurement group_id="O2" value="75.1" spread="10.25"/>
                    <measurement group_id="O3" value="74.8" spread="10.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3" spread="19.25"/>
                    <measurement group_id="O2" value="76" spread="12.03"/>
                    <measurement group_id="O3" value="76.3" spread="12.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.8" spread="17.52"/>
                    <measurement group_id="O2" value="82.6" spread="10.81"/>
                    <measurement group_id="O3" value="76.0" spread="17.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="16.76"/>
                    <measurement group_id="O2" value="74.1" spread="9.40"/>
                    <measurement group_id="O3" value="73.1" spread="12.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3" spread="17.81"/>
                    <measurement group_id="O2" value="73.2" spread="12.03"/>
                    <measurement group_id="O3" value="73.0" spread="10.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1" spread="18.79"/>
                    <measurement group_id="O2" value="72.0" spread="13.12"/>
                    <measurement group_id="O3" value="72.1" spread="11.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" spread="15.51"/>
                    <measurement group_id="O2" value="73.8" spread="12.37"/>
                    <measurement group_id="O3" value="73.7" spread="9.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Profile Over Time of Systolic Blood Pressure</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>The Profile Over Time of Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Study (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.3" spread="12.09"/>
                    <measurement group_id="O2" value="118.6" spread="10.15"/>
                    <measurement group_id="O3" value="118.5" spread="11.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.0" spread="12.49"/>
                    <measurement group_id="O2" value="122.0" spread="13.01"/>
                    <measurement group_id="O3" value="121.5" spread="14.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.5" spread="16.65"/>
                    <measurement group_id="O2" value="122.2" spread="14.06"/>
                    <measurement group_id="O3" value="130.5" spread="5.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.7" spread="14.2"/>
                    <measurement group_id="O2" value="125.1" spread="12.12"/>
                    <measurement group_id="O3" value="118.7" spread="14.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.1" spread="14.16"/>
                    <measurement group_id="O2" value="121.7" spread="13.14"/>
                    <measurement group_id="O3" value="117.5" spread="11.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.3" spread="15.55"/>
                    <measurement group_id="O2" value="122.1" spread="16.30"/>
                    <measurement group_id="O3" value="116.6" spread="10.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.0" spread="15.75"/>
                    <measurement group_id="O2" value="121.1" spread="12.97"/>
                    <measurement group_id="O3" value="115.7" spread="9.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Profile Over Time of Diastolic Blood Pressure</title>
        <time_frame>from baseline to 120 minutes following drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>The Profile Over Time of Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Study (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" spread="7.92"/>
                    <measurement group_id="O2" value="75.3" spread="8.25"/>
                    <measurement group_id="O3" value="74.8" spread="7.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6" spread="10.44"/>
                    <measurement group_id="O2" value="77.7" spread="8.36"/>
                    <measurement group_id="O3" value="77.3" spread="9.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" spread="10.91"/>
                    <measurement group_id="O2" value="79.6" spread="10.16"/>
                    <measurement group_id="O3" value="84.5" spread="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="9.06"/>
                    <measurement group_id="O2" value="78.7" spread="9.03"/>
                    <measurement group_id="O3" value="75.4" spread="9.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.0" spread="10.63"/>
                    <measurement group_id="O2" value="76.8" spread="9.01"/>
                    <measurement group_id="O3" value="76.6" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3" spread="10.91"/>
                    <measurement group_id="O2" value="75.7" spread="8.56"/>
                    <measurement group_id="O3" value="74.1" spread="5.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" spread="8.85"/>
                    <measurement group_id="O2" value="76.9" spread="8.84"/>
                    <measurement group_id="O3" value="75.7" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Sniff Test</title>
        <description>The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.</description>
        <time_frame>administered at baseline, 120 minutes and approximately 24 hours after drug administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Sniff Test</title>
          <description>The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Study (Baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="8.96"/>
                    <measurement group_id="O2" value="18.8" spread="10"/>
                    <measurement group_id="O3" value="21.2" spread="8.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="9.47"/>
                    <measurement group_id="O2" value="17.7" spread="9.48"/>
                    <measurement group_id="O3" value="20.9" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" spread="8.51"/>
                    <measurement group_id="O2" value="16.1" spread="8.74"/>
                    <measurement group_id="O3" value="20.4" spread="8.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoral Soft-tissue Anesthesia (Onset and Duration)</title>
        <description>Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints</description>
        <time_frame>up to 120 mins post-dose</time_frame>
        <population>The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.</population>
        <group_list>
          <group group_id="O1">
            <title>Kovacaine Mist, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O2">
            <title>Tetracaine Only, 3 Sprays Unilateral</title>
            <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
          </group>
          <group group_id="O3">
            <title>Placebo, 3 Sprays Unilateral</title>
            <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoral Soft-tissue Anesthesia (Onset and Duration)</title>
          <description>Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints</description>
          <population>The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Onset</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="7.5"/>
                    <measurement group_id="O2" value="19.5" spread="17.6"/>
                    <measurement group_id="O3" value="37.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Duration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" spread="27.0"/>
                    <measurement group_id="O2" value="32.1" spread="15.2"/>
                    <measurement group_id="O3" value="26.0" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours post-dosing</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Kovacaine Mist, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3% and Oxymetazoline HCl 0.05%&#xD;
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="E2">
          <title>Tetracaine Only, 3 Sprays Unilateral</title>
          <description>Tetracaine HCl 3%&#xD;
Tetracaine HCl 3%: 3 unilateral intranasal sprays per dose</description>
        </group>
        <group group_id="E3">
          <title>Placebo, 3 Sprays Unilateral</title>
          <description>Placebo&#xD;
Placebo: 3 unilateral intranasal sprays per dose</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis Orbital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <description>(tearing or watery eyes)</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <description>(Dental Pain, usually attributed to insufficient anesthesia)</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <description>(runny nose)</description>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pharyngeal hypoaesthesia</sub_title>
                <description>(throat numbness)</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Intranasal Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Adam D. Marberger, DDS</name_or_title>
      <organization>Jean Brown Research</organization>
      <phone>801-261-2000</phone>
    </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/NCT01710787
org study id: SR 3-02
nct id: NCT01710787
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and
      Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
The study will employ a multi-center, randomized, double-blind, placebo-controlled,
      parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered
      intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary
      right second premolar to maxillary left second premolar) sufficient to allow completion of
      the Study Dental Procedure.

      The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study
      sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated
      with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo.
      Recruitment will be from diverse dental patient populations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.
time frame: at 15 minutes with a 3 minute window
description: If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
measure: Intraoral Soft-tissue Anesthesia (Yes/no)
time frame: at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window
description: Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints
measure: Number of Participants With a Heart Rate Higher Than 125 Bpm
time frame: at any time within 120 minutes following drug administration
measure: Number of Participants With a Heart Rate Lower Than 50 Bpm
time frame: at any time within 120 minutes following drug administration
measure: Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg
time frame: at any time within 120 minutes following drug administration
measure: Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg
time frame: at any time within 120 minutes following drug administration
measure: Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg
time frame: at any time within 120 minutes following drug administration
measure: Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg
time frame: at any time within 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Heart Rate
time frame: from baseline to 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Systolic Blood Pressure
time frame: from baseline to 120 minutes following drug administration
measure: Absolute Maximum Change From Baseline in Diastolic Blood Pressure
time frame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Heart Rate
time frame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Systolic Blood Pressure
time frame: from baseline to 120 minutes following drug administration
measure: The Profile Over Time of Diastolic Blood Pressure
time frame: from baseline to 120 minutes following drug administration
measure: Alcohol Sniff Test
time frame: administered at baseline, 120 minutes and approximately 24 hours after drug administration
description: The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.
measure: Intraoral Soft-tissue Anesthesia (Onset and Duration)
time frame: up to 120 mins post-dose
description: Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints
arm group label: Kovacaine Mist, 3 sprays unilateral
arm group type: Experimental
description: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
arm group label: Tetracaine Only, 3 sprays unilateral
arm group type: Experimental
description: Tetracaine HCl 3%
arm group label: Placebo, 3 sprays unilateral
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
description: 3 unilateral intranasal sprays per dose
arm group label: Kovacaine Mist, 3 sprays unilateral
other name: Kovacaine Mist
intervention type: Drug
intervention name: Tetracaine HCl 3%
description: 3 unilateral intranasal sprays per dose
arm group label: Tetracaine Only, 3 sprays unilateral
other name: Active control
intervention type: Drug
intervention name: Placebo
description: 3 unilateral intranasal sprays per dose
arm group label: Placebo, 3 sprays unilateral
other name: Inactive ingredients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul A. Moore, DMD/PhD/MPH
role: Study Director
affiliation: University of Pittsburgh
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Tetracaine
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 