<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/NCT01675609</url>
  </required_header>
  <id_info>
    <org_study_id>11-100-0015</org_study_id>
    <nct_id>NCT01675609</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects</brief_title>
  <official_title>A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects</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 evaluate the safety and efficacy of brimonidine tartrate&#xD;
      0.025% ophthalmic solution used four times daily in a population of adult and geriatric&#xD;
      subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular redness</measure>
    <time_frame>at specified timepoints for up to 180 minutes</time_frame>
    <description>redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Redness</measure>
    <time_frame>up to 5 minutes post study medication instillation</time_frame>
    <description>evaluated prior to study medication instillation and at 5 minutes post instillation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Ocular Redness</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Brimonidine Tartrate 0.025%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 drop in each eye daily for up to 35 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine tartrate 0.025%</intervention_name>
    <description>1 drop in each eye for up to 35 days</description>
    <arm_group_label>Brimonidine Tartrate 0.025%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 40 years of age&#xD;
&#xD;
          -  Must have normal ocular health&#xD;
&#xD;
          -  Must have history of redness relief drop use or desire to use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not have any ocular/systemic health problems&#xD;
&#xD;
          -  Must agree to avoid disallowed medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ora, Inc.</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <disposition_first_submitted>July 28, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>July 28, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 31, 2014</disposition_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</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>Erythema</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, 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/NCT01675609
org study id: 11-100-0015
nct id: NCT01675609
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate
      0.025% ophthalmic solution used four times daily in a population of adult and geriatric
      subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ocular redness
time frame: at specified timepoints for up to 180 minutes
description: redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary
measure: Ocular Redness
time frame: up to 5 minutes post study medication instillation
description: evaluated prior to study medication instillation and at 5 minutes post instillation
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Brimonidine Tartrate 0.025%
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: 1 drop in each eye daily for up to 35 days
arm group label: Placebo
intervention type: Drug
intervention name: Brimonidine tartrate 0.025%
description: 1 drop in each eye for up to 35 days
arm group label: Brimonidine Tartrate 0.025%
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erythema
mesh term: Brimonidine Tartrate