<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/NCT02247804</url>
  </required_header>
  <id_info>
    <org_study_id>192024-091</org_study_id>
    <secondary_id>2014-003037-26</secondary_id>
    <nct_id>NCT02247804</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension</brief_title>
  <official_title>The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of bimatoprost SR in participants with&#xD;
      open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period&#xD;
      with an 8-month extended follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2014</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)</measure>
    <time_frame>Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 2 (Hour 0)</measure>
    <time_frame>Week 2 (Hour 0)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 2 (Hour 2)</measure>
    <time_frame>Week 2 (Hour 2)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 6 (Hour 0)</measure>
    <time_frame>Week 6 (Hour 0)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 6 (Hour 2)</measure>
    <time_frame>Week 6 (Hour 2)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 12 (Hour 0)</measure>
    <time_frame>Week 12 (Hour 0)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP in the Study Eye at Week 12 (Hour 2)</measure>
    <time_frame>Week 12 (Hour 2)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in IOP in the Study Eye</measure>
    <time_frame>Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">594</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Bimatoprost SR 15 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimatoprost SR 10 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Timolol 0.5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimatoprost SR</intervention_name>
    <description>Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.</description>
    <arm_group_label>Bimatoprost SR 10 μg</arm_group_label>
    <arm_group_label>Bimatoprost SR 15 μg</arm_group_label>
    <other_name>AGN-192024</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Comparator: Timolol 0.5%</intervention_name>
    <description>Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
    <arm_group_label>Bimatoprost SR 10 μg</arm_group_label>
    <arm_group_label>Bimatoprost SR 15 μg</arm_group_label>
    <arm_group_label>Timolol 0.5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham: Applicator Without Needle</intervention_name>
    <description>Sham administered on Day 1, Week 16, and Week 32.</description>
    <arm_group_label>Bimatoprost SR 10 μg</arm_group_label>
    <arm_group_label>Bimatoprost SR 15 μg</arm_group_label>
    <arm_group_label>Timolol 0.5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Timolol Vehicle (placebo)</intervention_name>
    <description>Timolol vehicle administered once in the morning and once in the evening for up to 20 months.</description>
    <arm_group_label>Bimatoprost SR 10 μg</arm_group_label>
    <arm_group_label>Bimatoprost SR 15 μg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes&#xD;
        require IOP-lowering treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous enrollment in another Allergan Bimatoprost SR Study.&#xD;
&#xD;
          -  Eye surgery (including cataract surgery) and/or any eye laser surgery within the past&#xD;
             6 months in the study eye&#xD;
&#xD;
          -  Anticipated need for laser eye surgery in either eye within the first 52 weeks of the&#xD;
             study duration&#xD;
&#xD;
          -  History of glaucoma surgery&#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_official>
    <last_name>Marina Bejanian</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Glaucoma Specialists</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lugene Eye Institute</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeside Vision Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Glaucoma Center, Shiley Eye Center UCSD</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantis Eye Care</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glaucoma Institute of Beverly Hills</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montebello Medical Eye Center Inc.</name>
      <address>
        <city>Montebello</city>
        <state>California</state>
        <zip>90640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Eye Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martel Eye Medical Group</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grutzmacher, Lewis and Sierra, Inc.</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Eye Associates</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Associates of Colorado Springs</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Eye Center, INC</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nature Coast Clinical Research</name>
      <address>
        <city>Crystal River</city>
        <state>Florida</state>
        <zip>34429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levenson Eye Associates</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Florida Eye Institute</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34994</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Research Associates, LLC</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Eye Specialists</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60619</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of America Eye Care PA</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Doctors of Washington</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedRACS, LLC</name>
      <address>
        <city>Quincy</city>
        <state>Massachusetts</state>
        <zip>02169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocular Immunology and Uveitis Foundation</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Constultants, P.A.</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifelong Vision Foundation</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moyes Eye Center, PC</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern New Jersey Eye Institute P.A.</name>
      <address>
        <city>South Orange</city>
        <state>New Jersey</state>
        <zip>07079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyecare Ophthalmology Associates, PC</name>
      <address>
        <city>Bethpage</city>
        <state>New York</state>
        <zip>11714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary of Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Ophthalmological Group PC</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2000 North Village Avenue</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glaucoma Consultants of the Capital Region</name>
      <address>
        <city>Slingerlands</city>
        <state>New York</state>
        <zip>12159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>8 Medical Park Drive</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albemarle Clinical Trials, LLC</name>
      <address>
        <city>Elizabeth City</city>
        <state>North Carolina</state>
        <zip>27909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Havener Eye Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drs Fine Hoffman &amp; Sims, LLC</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wills Eye Institute - Glaucoma Research Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associates in Ophthalmology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Centers for Sight PC</name>
      <address>
        <city>Florence</city>
        <state>South Carolina</state>
        <zip>29501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VRF Eye Specialty Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Vision Associates</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone Research, LTD</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glaucoma Associates of Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cataract, Glaucoma &amp; Refractive Surgery Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Eye Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Focal Point Vision</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R and R Eye Research, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Ophthalmology Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Eye Center</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision Eye Institute Chatswood</name>
      <address>
        <city>Chatsworth</city>
        <zip>New South Wales</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Eye Specialists</name>
      <address>
        <city>Fitzroy</city>
        <zip>Victoria 3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waverley Eye Clinic</name>
      <address>
        <city>Glen Waverley</city>
        <zip>Vctoria 3150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marsden Eye Specialists, Parramatta</name>
      <address>
        <city>Paramatta</city>
        <zip>New South Wales</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preston Eye Clinic</name>
      <address>
        <city>Preston</city>
        <zip>Victoria 3072</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>B-3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart Tilman</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Goias</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <zip>74180-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elo Oftalmologistas Associados</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30140-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Campinas Oftalmologia</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13010-111</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Medicina dos Olhos</name>
      <address>
        <city>Osasco</city>
        <state>Sao Paulo</state>
        <zip>06010-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Olhos MS</name>
      <address>
        <city>Rio Verde</city>
        <zip>79002-075</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Escola Paulista de Medicina</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas - Faculdade de Medicina</name>
      <address>
        <city>Sao Paulo</city>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glostrup Hospital</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hong Kong Eye Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Medical Center</name>
      <address>
        <city>Pecs</city>
        <zip>H-7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markusovszky Korhaz</name>
      <address>
        <city>Szombathely</city>
        <zip>H-9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zala Megyei Kórház</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>H-8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>78278</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion M.C.</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oftalmológico Mácula Diagnóstico y Tratamiento</name>
      <address>
        <city>Lima</city>
        <zip>Lima 27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asian Eye Institute</name>
      <address>
        <city>Makati</city>
        <zip>1200</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Eyecare &amp; Laser Institute</name>
      <address>
        <city>Makati</city>
        <zip>1200</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Makati Medical Center</name>
      <address>
        <city>Makati</city>
        <zip>1229</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatna Klinika Okulistyczna OFTALMIKA</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-631</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimum Profesorskie Centrum Okulistyki</name>
      <address>
        <city>Gdansk</city>
        <zip>80-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public Clinical Hospital No. 1</name>
      <address>
        <city>Lublin</city>
        <zip>20-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZOZ OKO- TEST Poradnia Okulistyczna</name>
      <address>
        <city>Nowy Targ</city>
        <zip>34-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic and Microsurgery Center of the Eye LENS</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-424</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Sp. z o.o</name>
      <address>
        <city>Warsaw</city>
        <zip>01-364</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Okulistyki WIML</name>
      <address>
        <city>Warsaw</city>
        <zip>01-755</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny</name>
      <address>
        <city>Warszawa</city>
        <zip>01-755</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteck Szpital Kliniczny</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-368</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Clinic d'Oftalmologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala de la Retina</name>
      <address>
        <city>Barcelona</city>
        <zip>08017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>Barcelona</city>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buddhist Tzu Chi General Hospital (BTCGH)</name>
      <address>
        <city>Hualien</city>
        <zip>970</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Denmark</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Chile</country>
    <country>China</country>
    <country>France</country>
    <country>Switzerland</country>
  </removed_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>April 3, 2020</results_first_submitted>
  <results_first_submitted_qc>April 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2020</results_first_posted>
  <disposition_first_submitted>February 7, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>February 7, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 12, 2019</disposition_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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>Timolol</mesh_term>
    <mesh_term>Bimatoprost</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02247804/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02247804/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bimatoprost SR 15 μg</title>
          <description>Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="P2">
          <title>Bimatoprost SR 10 μg</title>
          <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="P3">
          <title>Timolol 0.5%: Comparator</title>
          <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="198"/>
                <participants group_id="P3" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received (Sham or Bimatoprost SR)</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
                <participants group_id="P2" count="197"/>
                <participants group_id="P3" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="194"/>
                <participants group_id="P3" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not Treated</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="191"/>
                <participants group_id="P3" count="187"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="186"/>
                <participants group_id="P3" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="183"/>
                <participants group_id="P3" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="173"/>
                <participants group_id="P3" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population was defined as all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Bimatoprost SR 15 μg</title>
          <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="B2">
          <title>Bimatoprost SR 10 μg</title>
          <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="B3">
          <title>Timolol 0.5%: Comparator</title>
          <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="B4">
          <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="198"/>
            <count group_id="B2" value="198"/>
            <count group_id="B3" value="198"/>
            <count group_id="B4" value="594"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.5" spread="13.0"/>
                    <measurement group_id="B2" value="62.6" spread="11.5"/>
                    <measurement group_id="B3" value="62.5" spread="11.0"/>
                    <measurement group_id="B4" value="62.5" spread="11.9"/>
                  </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="96"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="106"/>
                    <measurement group_id="B4" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="130"/>
                    <measurement group_id="B4" value="375"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intraocular Pressure (IOP)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye.</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Hour 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.76" lower_limit="18.0" upper_limit="32.0"/>
                    <measurement group_id="B2" value="24.64" lower_limit="21.5" upper_limit="32.0"/>
                    <measurement group_id="B3" value="24.63" lower_limit="16.0" upper_limit="32.0"/>
                    <measurement group_id="B4" value="24.68" lower_limit="16.0" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.56" lower_limit="19.0" upper_limit="32.0"/>
                    <measurement group_id="B2" value="23.29" lower_limit="19.0" upper_limit="32.0"/>
                    <measurement group_id="B3" value="23.19" lower_limit="16.0" upper_limit="32.0"/>
                    <measurement group_id="B4" value="23.35" lower_limit="16.0" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
        <time_frame>Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)</time_frame>
        <population>ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
          <population>ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.</population>
          <units>millimeters of mercury (mm Hg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline at Hour 0, Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="192"/>
                    <count group_id="O3" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.46" spread="0.29"/>
                    <measurement group_id="O2" value="-6.38" spread="0.28"/>
                    <measurement group_id="O3" value="-6.05" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Hour 2, Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                    <count group_id="O2" value="192"/>
                    <count group_id="O3" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.18" spread="0.26"/>
                    <measurement group_id="O2" value="-6.69" spread="0.25"/>
                    <measurement group_id="O3" value="-6.48" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.2950</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.3904</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>0.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0464</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.5383</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 2 (Hour 0)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 2 (Hour 0)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 2 (Hour 0)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="196"/>
                <count group_id="O3" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.82" spread="0.25"/>
                    <measurement group_id="O2" value="17.02" spread="0.25"/>
                    <measurement group_id="O3" value="17.83" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0033</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.68</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0187</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.47</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 2 (Hour 2)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 2 (Hour 2)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 2 (Hour 2)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="196"/>
                <count group_id="O3" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.48" spread="0.22"/>
                    <measurement group_id="O2" value="16.42" spread="0.22"/>
                    <measurement group_id="O3" value="17.33" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0057</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>-0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0031</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.50</ci_lower_limit>
            <ci_upper_limit>-0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 6 (Hour 0)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 6 (Hour 0)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 6 (Hour 0)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="197"/>
                <count group_id="O3" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.08" spread="0.24"/>
                    <measurement group_id="O2" value="16.88" spread="0.23"/>
                    <measurement group_id="O3" value="17.71" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0547</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.26</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0107</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 6 (Hour 2)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 6 (Hour 2)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 6 (Hour 2)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="197"/>
                <count group_id="O3" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.62" spread="0.23"/>
                    <measurement group_id="O2" value="16.51" spread="0.22"/>
                    <measurement group_id="O3" value="17.16" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0860</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.16</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0362</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 12 (Hour 0)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 12 (Hour 0)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 12 (Hour 0)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.53" spread="0.29"/>
                    <measurement group_id="O2" value="17.61" spread="0.28"/>
                    <measurement group_id="O3" value="17.94" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.2950</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.3904</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>0.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IOP in the Study Eye at Week 12 (Hour 2)</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
        <time_frame>Week 12 (Hour 2)</time_frame>
        <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>IOP in the Study Eye at Week 12 (Hour 2)</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.</description>
          <population>ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="192"/>
                <count group_id="O3" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.81" spread="0.26"/>
                    <measurement group_id="O2" value="17.30" spread="0.25"/>
                    <measurement group_id="O3" value="17.51" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0464</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.5383</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in IOP in the Study Eye</title>
        <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
        <time_frame>Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)</time_frame>
        <population>ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost SR 15 μg</title>
            <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost SR 10 μg</title>
            <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
          <group group_id="O3">
            <title>Timolol 0.5%: Comparator</title>
            <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IOP in the Study Eye</title>
          <description>IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
          <population>ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline at Hour 0, Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                    <count group_id="O2" value="196"/>
                    <count group_id="O3" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.17" spread="0.25"/>
                    <measurement group_id="O2" value="-6.97" spread="0.25"/>
                    <measurement group_id="O3" value="-6.17" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Hour 2, Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                    <count group_id="O2" value="196"/>
                    <count group_id="O3" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.52" spread="0.22"/>
                    <measurement group_id="O2" value="-7.57" spread="0.22"/>
                    <measurement group_id="O3" value="-6.67" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Hour 0, Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.91" spread="0.24"/>
                    <measurement group_id="O2" value="-7.11" spread="0.23"/>
                    <measurement group_id="O3" value="-6.29" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Hour 2, Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.37" spread="0.23"/>
                    <measurement group_id="O2" value="-7.48" spread="0.22"/>
                    <measurement group_id="O3" value="-6.83" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0033</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.68</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0187</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.47</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0057</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>-0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0031</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.50</ci_lower_limit>
            <ci_upper_limit>-0.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0547</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.26</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0107</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0860</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.16</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was &lt; 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.</non_inferiority_desc>
            <p_value>0.0362</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First dose of study drug to last visit (Up to approximately 20 months)</time_frame>
      <desc>Safety population included all participants who received at least 1 dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bimatoprost SR 15 μg</title>
          <description>Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="E2">
          <title>Bimatoprost SR 10 μg</title>
          <description>Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
        <group group_id="E3">
          <title>Timolol 0.5%: Comparator</title>
          <description>Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>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="2" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal endothelial cell loss</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Corneal touch</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Ulcerative keratitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Post procedural sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Joint instability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Invasive breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Prostate cancer recurrent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Internal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>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="143" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="138" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="105" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="47" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Foreign body sensation in eyes</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Corneal endothelial cell loss</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Anterior chamber cell</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="193"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="197"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT02247804
org study id: 192024-091
secondary id: 2014-003037-26
nct id: NCT02247804
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of bimatoprost SR in participants with
      open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period
      with an 8-month extended follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
time frame: Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
measure: IOP in the Study Eye at Week 2 (Hour 0)
time frame: Week 2 (Hour 0)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: IOP in the Study Eye at Week 2 (Hour 2)
time frame: Week 2 (Hour 2)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: IOP in the Study Eye at Week 6 (Hour 0)
time frame: Week 6 (Hour 0)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: IOP in the Study Eye at Week 6 (Hour 2)
time frame: Week 6 (Hour 2)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: IOP in the Study Eye at Week 12 (Hour 0)
time frame: Week 12 (Hour 0)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: IOP in the Study Eye at Week 12 (Hour 2)
time frame: Week 12 (Hour 2)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
measure: Change From Baseline in IOP in the Study Eye
time frame: Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
description: IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
arm group label: Bimatoprost SR 15 μg
arm group type: Experimental
description: Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
arm group label: Bimatoprost SR 10 μg
arm group type: Experimental
description: Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
arm group label: Timolol 0.5%
arm group type: Active Comparator
description: Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
intervention type: Drug
intervention name: Bimatoprost SR
description: Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
arm group label: Bimatoprost SR 10 μg
arm group label: Bimatoprost SR 15 μg
other name: AGN-192024
intervention type: Drug
intervention name: Active Comparator: Timolol 0.5%
description: Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
arm group label: Bimatoprost SR 10 μg
arm group label: Bimatoprost SR 15 μg
arm group label: Timolol 0.5%
intervention type: Other
intervention name: Sham: Applicator Without Needle
description: Sham administered on Day 1, Week 16, and Week 32.
arm group label: Bimatoprost SR 10 μg
arm group label: Bimatoprost SR 15 μg
arm group label: Timolol 0.5%
intervention type: Drug
intervention name: Timolol Vehicle (placebo)
description: Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
arm group label: Bimatoprost SR 10 μg
arm group label: Bimatoprost SR 15 μg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marina Bejanian
role: Study Director
affiliation: Allergan
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: Denmark
country: Hong Kong
country: Hungary
country: Israel
country: Peru
country: Philippines
country: Poland
country: Spain
country: Taiwan
country: United States
country: Chile
country: China
country: France
country: Switzerland
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Timolol
mesh term: Bimatoprost
provided document: 
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baseline: 
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reported events: 
certain agreements: 
point of contact: 