<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/NCT01722604</url>
  </required_header>
  <id_info>
    <org_study_id>CD-11-265</org_study_id>
    <nct_id>NCT01722604</nct_id>
  </id_info>
  <brief_title>Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch &amp; Lomb Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch &amp; Lomb Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this prospective study is to demonstrate the therapeutic equivalence of&#xD;
      topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic&#xD;
      suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure (IOP) at Week 12</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Intraocular Pressure (IOP) From Baseline to Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Glaucoma</condition>
  <condition>Open Angle or Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Azopt 1% ophthalmic suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ophthalmic suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brinzolamide 1% ophthalmic suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ophthalmic suspension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>brinzolamide 1% ophthalmic suspension</intervention_name>
    <description>brinzolamide 1% ophthalmic suspension</description>
    <arm_group_label>Brinzolamide 1% ophthalmic suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azopt 1%</intervention_name>
    <description>Azopt 1%, RLD</description>
    <arm_group_label>Azopt 1% ophthalmic suspension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and females 18 years of age or older,&#xD;
&#xD;
          -  diagnosed with primary open-angle glaucoma or ocular hypertension.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal&#xD;
             tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle&#xD;
             glaucoma,&#xD;
&#xD;
          -  ocular hypertension.&#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>US01</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>May 14, 2021</results_first_submitted>
  <results_first_submitted_qc>June 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2021</results_first_posted>
  <disposition_first_submitted>March 29, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>March 29, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 4, 2019</disposition_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</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>Brinzolamide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Brinzolamide 1% Ophthalmic Suspension</title>
          <description>ophthalmic suspension&#xD;
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension</description>
        </group>
        <group group_id="P2">
          <title>Azopt 1% Ophthalmic Suspension</title>
          <description>Ophthalmic suspension&#xD;
Azopt 1%: Azopt 1%, RLD</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="129"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Brinzolamide 1% Ophthalmic Suspension</title>
          <description>ophthalmic suspension&#xD;
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension</description>
        </group>
        <group group_id="B2">
          <title>Azopt 1% Ophthalmic Suspension</title>
          <description>Ophthalmic suspension&#xD;
Azopt 1%: Azopt 1%, RLD</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="129"/>
            <count group_id="B2" value="129"/>
            <count group_id="B3" value="258"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.1" lower_limit="39" upper_limit="91"/>
                    <measurement group_id="B2" value="65.3" lower_limit="39" upper_limit="89"/>
                    <measurement group_id="B3" value="64.6" lower_limit="39" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraocular Pressure (IOP) at Week 12</title>
        <time_frame>Week 12</time_frame>
        <population>The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.</population>
        <group_list>
          <group group_id="O1">
            <title>Brinzolamide 1% Ophthalmic Suspension</title>
            <description>ophthalmic suspension&#xD;
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension</description>
          </group>
          <group group_id="O2">
            <title>Azopt 1% Ophthalmic Suspension</title>
            <description>Ophthalmic suspension&#xD;
Azopt 1%: Azopt 1%, RLD</description>
          </group>
        </group_list>
        <measure>
          <title>Intraocular Pressure (IOP) at Week 12</title>
          <population>The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="3.21"/>
                    <measurement group_id="O2" value="20.8" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intraocular Pressure (IOP) From Baseline to Week 12</title>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.</population>
        <group_list>
          <group group_id="O1">
            <title>Brinzolamide 1% Ophthalmic Suspension</title>
            <description>ophthalmic suspension&#xD;
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension</description>
          </group>
          <group group_id="O2">
            <title>Azopt 1% Ophthalmic Suspension</title>
            <description>Ophthalmic suspension&#xD;
Azopt 1%: Azopt 1%, RLD</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intraocular Pressure (IOP) From Baseline to Week 12</title>
          <population>The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="2.79"/>
                    <measurement group_id="O2" value="-5.4" spread="3.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Brinzolamide 1% Ophthalmic Suspension</title>
          <description>ophthalmic suspension&#xD;
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension</description>
        </group>
        <group group_id="E2">
          <title>Azopt 1% Ophthalmic Suspension</title>
          <description>Ophthalmic suspension&#xD;
Azopt 1%: Azopt 1%, RLD</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site complication</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="129"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="129"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Please contact sponsor directly for details.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Daniel Donatello</name_or_title>
      <organization>Bausch &amp; Lomb</organization>
      <phone>(585) 338-5306</phone>
      <email>Daniel.Donatello@bausch.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01722604
org study id: CD-11-265
nct id: NCT01722604
lead sponsor: 
has dmc: No
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of
      topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic
      suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Intraocular Pressure (IOP) at Week 12
time frame: Week 12
measure: Change in Intraocular Pressure (IOP) From Baseline to Week 12
time frame: Baseline, Week 12
arm group label: Azopt 1% ophthalmic suspension
arm group type: Active Comparator
description: Ophthalmic suspension
arm group label: Brinzolamide 1% ophthalmic suspension
arm group type: Experimental
description: ophthalmic suspension
intervention type: Drug
intervention name: brinzolamide 1% ophthalmic suspension
description: brinzolamide 1% ophthalmic suspension
arm group label: Brinzolamide 1% ophthalmic suspension
intervention type: Drug
intervention name: Azopt 1%
description: Azopt 1%, RLD
arm group label: Azopt 1% ophthalmic suspension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ocular Hypertension
mesh term: Brinzolamide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 