<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/NCT04475432</url>
  </required_header>
  <id_info>
    <org_study_id>TRS-009</org_study_id>
    <nct_id>NCT04475432</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis</brief_title>
  <acronym>Saturn-1</acronym>
  <official_title>Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tarsus Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tarsus Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop,&#xD;
      to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite&#xD;
      frequently found in human hair follicles. The hypothesis for the study is the proportion of&#xD;
      participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion&#xD;
      cured by treatment with its vehicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial&#xD;
      to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of&#xD;
      Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy&#xD;
      of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to&#xD;
      severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon&#xD;
      collarettes. Safety will be determined by assessing adverse effects related to the treatment&#xD;
      as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp&#xD;
      biomicroscopy and dilated ophthalmoscopy findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">May 4, 2021</completion_date>
  <primary_completion_date type="Actual">May 4, 2021</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>Active arm: TP-03 0.25%&#xD;
Control arm: Vehicle of TP-03</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of participants cured based on their collarette score</measure>
    <time_frame>43 days</time_frame>
    <description>Cure is defined as the presence of no more than 2 collarettes on the upper eyelid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with their Demodex mites eradicated</measure>
    <time_frame>43 days</time_frame>
    <description>Mite eradication is defined as a mite density of 0 mites per lash</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants cured based on a composite of collarette score and erythema cure</measure>
    <time_frame>43 days</time_frame>
    <description>Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">421</enrollment>
  <condition>Blepharitis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TP-03, 0.25%</intervention_name>
    <description>TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Lotilaner ophthalmic solution, 0.25%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TP-03 Vehicle</intervention_name>
    <description>Vehicle of TP-03 ophthalmic solution, administered twice a day</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing to sign the informed consent and deemed capable of complying with the&#xD;
             requirements of the study protocol&#xD;
&#xD;
          -  Meet all of the following criteria in at least one eye: Have more than 10 lashes with&#xD;
             collarettes present on the upper lid; have at least mild erythema of the upper eyelid&#xD;
             margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or&#xD;
             more mites per lash&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have used lid hygiene products within 14 days of Screening or unwilling to forego the&#xD;
             use of lid hygiene products during the study&#xD;
&#xD;
          -  Have worn contact lenses within 7 days of Screening or be unwilling to forego contact&#xD;
             lens wear during the study&#xD;
&#xD;
          -  Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be&#xD;
             unwilling to forego their use during the study&#xD;
&#xD;
          -  Pregnancy or lactation&#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>David Wirta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eye Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cornea and Cataract Consultants of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visionary Eye Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision Institute</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Cornea Associates, LLC</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washburn Research LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Care Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Associates</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oculus Research, Inc at EyecareCenter</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vita Eye Clinic</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; Christie and Associates, PC</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care, P.A.</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Research Organization</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Eye Center</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <disposition_first_submitted>April 10, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>April 13, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 15, 2022</disposition_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Demodex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04475432
org study id: TRS-009
nct id: NCT04475432
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop,
      to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite
      frequently found in human hair follicles. The hypothesis for the study is the proportion of
      participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion
      cured by treatment with its vehicle.
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial
      to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of
      Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy
      of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to
      severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon
      collarettes. Safety will be determined by assessing adverse effects related to the treatment
      as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp
      biomicroscopy and dilated ophthalmoscopy findings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Active arm: TP-03 0.25%
Control arm: Vehicle of TP-03
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
measure: The proportion of participants cured based on their collarette score
time frame: 43 days
description: Cure is defined as the presence of no more than 2 collarettes on the upper eyelid
measure: The proportion of participants with their Demodex mites eradicated
time frame: 43 days
description: Mite eradication is defined as a mite density of 0 mites per lash
measure: The proportion of participants cured based on a composite of collarette score and erythema cure
time frame: 43 days
description: Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid
arm group label: Active
arm group type: Experimental
description: TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
arm group label: Control
arm group type: Placebo Comparator
description: Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
intervention type: Drug
intervention name: TP-03, 0.25%
description: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
arm group label: Active
other name: Lotilaner ophthalmic solution, 0.25%
intervention type: Drug
intervention name: TP-03 Vehicle
description: Vehicle of TP-03 ophthalmic solution, administered twice a day
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Wirta, MD
role: Principal Investigator
affiliation: Eye Research Foundation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Blepharitis
mesh term: Ophthalmic Solutions
sharing ipd: No
submitted: August 25, 2023