<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/NCT03266081</url>
  </required_header>
  <id_info>
    <org_study_id>HS#: 14-00614</org_study_id>
    <nct_id>NCT03266081</nct_id>
  </id_info>
  <brief_title>Bupivacaine Epiphora Trial</brief_title>
  <official_title>Improving Epiphora &amp; Ptosis With Bupivacaine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate quantitative improvement in excessive tearing&#xD;
      after administration of Bupivacaine, a local anesthetic, into the affected eyelids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients&#xD;
  </why_stopped>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">August 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 23, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Lacrimal Tear Lake at 6 months</measure>
    <time_frame>measurements at baseline and 6 months</time_frame>
    <description>Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Lid distraction at 6 months</measure>
    <time_frame>measurements at baseline and 6 months</time_frame>
    <description>distance (in mm) that the eyelids can be maximally pulled from the globe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Lid snap back at 6 months</measure>
    <time_frame>measurements at baseline and 6 months</time_frame>
    <description>Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Epiphora</condition>
  <condition>Ptosis</condition>
  <arm_group>
    <arm_group_label>0.75% bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.75% bupivacaine</intervention_name>
    <description>topical anesthetic</description>
    <arm_group_label>0.75% bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients age 18 and above, patients with unilateral or bilateral excessive tearing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients&#xD;
        using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated&#xD;
        with bupivacaine and norepinephrine combinations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert Y Wu, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Albert Wu</investigator_full_name>
    <investigator_title>Assistant Professor, Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacrimal Apparatus Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03266081
org study id: HS#: 14-00614
nct id: NCT03266081
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to investigate quantitative improvement in excessive tearing
      after administration of Bupivacaine, a local anesthetic, into the affected eyelids.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Lacrimal Tear Lake at 6 months
time frame: measurements at baseline and 6 months
description: Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye
measure: Change from baseline Lid distraction at 6 months
time frame: measurements at baseline and 6 months
description: distance (in mm) that the eyelids can be maximally pulled from the globe
measure: Change from baseline Lid snap back at 6 months
time frame: measurements at baseline and 6 months
description: Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers
arm group label: 0.75% bupivacaine
arm group type: Experimental
intervention type: Drug
intervention name: 0.75% bupivacaine
description: topical anesthetic
arm group label: 0.75% bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Albert Y Wu, MD PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Albert Wu
investigator title: Assistant Professor, Ophthalmology
mesh term: Lacrimal Apparatus Diseases
mesh term: Bupivacaine
sharing ipd: No