<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/NCT03235232</url>
  </required_header>
  <id_info>
    <org_study_id>EMS0117</org_study_id>
    <nct_id>NCT03235232</nct_id>
  </id_info>
  <brief_title>BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension</brief_title>
  <official_title>Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</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 evaluate the clinical efficacy of the BREMEN eye drops in the&#xD;
      treatment of primary open-angle glaucoma or intraocular hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety will be evaluated through the adverse events occurrences</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">384</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Primary Open-angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>BREMEN eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop in affected eye(s), each 12 hours for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combigan®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BREMEN eye drops</intervention_name>
    <description>1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.</description>
    <arm_group_label>BREMEN eye drops</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combigan®</intervention_name>
    <description>1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.</description>
    <arm_group_label>Combigan®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Consent;&#xD;
&#xD;
          -  Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs&#xD;
             treatment with drugs association to control the intraocular pressure;&#xD;
&#xD;
          -  Participants who have 20/80 visual acuity or more, in both eyes;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with any clinical significant disease that, after evaluation of the&#xD;
             investigator, can´t participate in the study;&#xD;
&#xD;
          -  Participants with active eye disease, which in the investigator opinion may interfere&#xD;
             in the results of this clinical trial;&#xD;
&#xD;
          -  Participants presenting previous diagnosis of non-operated cataract, high myopia, high&#xD;
             astigmatism, pseudoexfoliation and corneal deformities;&#xD;
&#xD;
          -  Participants who had significant visual loss in the last year;&#xD;
&#xD;
          -  Treatment-naive participants for open-angle glaucoma or ocular hypertension;&#xD;
&#xD;
          -  Participants nonresponders to previous triple combination drug therapy, used in&#xD;
             concomitance;&#xD;
&#xD;
          -  Participants with previous ocular or intraocular surgery within six months prior to&#xD;
             enrollment in the clinical trial;&#xD;
&#xD;
          -  Participants with history of hypersensitivity to any formula compounds;&#xD;
&#xD;
          -  Participants presenting contraindications to use of beta-adrenergic antagonists;&#xD;
&#xD;
          -  Participants diagnosed with uncontrolled cardiovascular disease;&#xD;
&#xD;
          -  Participants with severe renal insufficiency or hyperchloremic acidosis;&#xD;
&#xD;
          -  Participants in therapy with monoamine oxidase inhibitors (MAOIs);&#xD;
&#xD;
          -  Participants who were in use of drugs that can interfere in the evaluation;&#xD;
&#xD;
          -  Pregnancy or risk of pregnancy and lactating patients;&#xD;
&#xD;
          -  Alcoholism or illicit drug abuse in the last two years;&#xD;
&#xD;
          -  Participation in clinical trial in the year prior to this study.&#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_contact>
    <last_name>Roberto B. Amazonas, MD</last_name>
    <phone>+551938879851</phone>
    <email>pesquisa.clinica@ems.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Allegisa</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13.084-791</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</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>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Brimonidine Tartrate, Timolol Maleate Drug Combination</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03235232
org study id: EMS0117
nct id: NCT03235232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the
      treatment of primary open-angle glaucoma or intraocular hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
time frame: 8 weeks
measure: Safety will be evaluated through the adverse events occurrences
time frame: 8 weeks
arm group label: BREMEN eye drops
arm group type: Experimental
description: 1 drop in affected eye(s), each 12 hours for 8 weeks.
arm group label: Combigan®
arm group type: Active Comparator
description: 1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.
intervention type: Drug
intervention name: BREMEN eye drops
description: 1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
arm group label: BREMEN eye drops
intervention type: Drug
intervention name: Combigan®
description: 1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
arm group label: Combigan®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto B. Amazonas, MD
phone: +551938879851
email: pesquisa.clinica@ems.com.br
facility: 
status: Recruiting
country: Brazil
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Ophthalmic Solutions
mesh term: Brimonidine Tartrate, Timolol Maleate Drug Combination