<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/NCT01687426</url>
  </required_header>
  <id_info>
    <org_study_id>12-150-0001</org_study_id>
    <nct_id>NCT01687426</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension</brief_title>
  <official_title>A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye Therapies, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye Therapies, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the intraocular Pressure (IOP) lowering response&#xD;
      and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects&#xD;
      with open angle glaucoma or ocular hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety</measure>
    <time_frame>For up to 8 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Glaucoma and Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Brimonidine Tartrate 0.025%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine Tartrate 0.025%</intervention_name>
    <description>1 drop in each eye daily four times a day for 14 days</description>
    <arm_group_label>Brimonidine Tartrate 0.025%</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>1 drop in each eye daily four times a day for 14 days</description>
    <arm_group_label>Brimonidine Tartrate 0.025%</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age at Visit 1 (Screening), of either sex and any race&#xD;
&#xD;
          -  Be willing and able to provide written informed consent prior to any study procedures&#xD;
             being performed.&#xD;
&#xD;
          -  Be willing and able to follow all instructions and attend all study visits.&#xD;
&#xD;
          -  Be willing to discontinue use of disallowed medication&#xD;
&#xD;
          -  Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic&#xD;
             angle closure glaucoma with a patent iridotomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have known sensitivity or poor tolerance to brimonidine or any other component of the&#xD;
             study medications.&#xD;
&#xD;
          -  Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or&#xD;
             chronic angle closure glaucoma with patent iridotomy.&#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>Clinical Site</name>
      <address>
        <city>Winchester</city>
        <state>Massachusetts</state>
        <zip>01890</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>December 21, 2012</last_update_submitted>
  <last_update_submitted_qc>December 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 25, 2012</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>Brimonidine Tartrate</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/NCT01687426
org study id: 12-150-0001
nct id: NCT01687426
lead sponsor: 
has dmc: No
The purpose of this study is to determine the intraocular Pressure (IOP) lowering response
      and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects
      with open angle glaucoma or ocular hypertension.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: IOP
time frame: 14 days
measure: Number of Participants with Adverse Events as a Measure of Safety
time frame: For up to 8 weeks
arm group label: Brimonidine Tartrate 0.025%
arm group type: Active Comparator
arm group label: Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Brimonidine Tartrate 0.025%
description: 1 drop in each eye daily four times a day for 14 days
arm group label: Brimonidine Tartrate 0.025%
arm group label: Vehicle
intervention type: Drug
intervention name: Vehicle
description: 1 drop in each eye daily four times a day for 14 days
arm group label: Brimonidine Tartrate 0.025%
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Brimonidine Tartrate