<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/NCT03825380</url>
  </required_header>
  <id_info>
    <org_study_id>LT4032-301</org_study_id>
    <nct_id>NCT03825380</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients</brief_title>
  <official_title>Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratoires Thea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratoires Thea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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 assess the efficacy and safety of T4032 versus Lumigan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2018</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 3, 2021</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-Ocular Pressure</measure>
    <time_frame>Week 12</time_frame>
    <description>Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">485</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>T4032</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumigan®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimatoprost</intervention_name>
    <description>Eyedrops</description>
    <arm_group_label>T4032</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lumigan®</intervention_name>
    <description>Eyedrops</description>
    <arm_group_label>Lumigan®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent signed and dated.&#xD;
&#xD;
          -  Both eyes with diagnosed open-angle glaucoma or ocular hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of trauma, infection, clinically significant inflammation within the 3&#xD;
             previous months.&#xD;
&#xD;
          -  Uncontrolled diabetic patient.&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Estonia</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bimatoprost</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 12, 2022</submitted>
    <returned>February 8, 2023</returned>
    <submitted>February 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03825380
org study id: LT4032-301
nct id: NCT03825380
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Intra-Ocular Pressure
time frame: Week 12
description: Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
arm group label: T4032
arm group type: Experimental
arm group label: Lumigan®
arm group type: Active Comparator
intervention type: Drug
intervention name: Bimatoprost
description: Eyedrops
arm group label: T4032
intervention type: Drug
intervention name: Lumigan®
description: Eyedrops
arm group label: Lumigan®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Estonia
responsible party type: Sponsor
mesh term: Ocular Hypertension
mesh term: Bimatoprost
submitted: May 12, 2022
returned: February 8, 2023
submitted: February 9, 2023