<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/NCT02250651</url>
  </required_header>
  <id_info>
    <org_study_id>192024-092</org_study_id>
    <secondary_id>2014-003186-24</secondary_id>
    <nct_id>NCT02250651</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients 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 sustained-release (SR) in&#xD;
      patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month&#xD;
      treatment period 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 22, 2020</completion_date>
  <primary_completion_date type="Actual">October 25, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)</measure>
    <time_frame>Baseline (Up to 3 days prior to Day 1 at 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 (Up to 3 days prior to Day 1 at 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">528</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 micrograms (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%: Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Both Eyes: 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>
  </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%: Comparator</arm_group_label>
  </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%: Comparator</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 within the first 52 weeks of the 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>Margot Goodkin</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eye Center South</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Eye Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vold Vision</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mark B. Kislinger, MD, Inc.</name>
      <address>
        <city>Glendora</city>
        <state>California</state>
        <zip>91741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Eye Specialists</name>
      <address>
        <city>Hemet</city>
        <state>California</state>
        <zip>92545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Eye Physicians and Surgeons</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Eye Associates, Inc.</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shasta Eye Medical Group, Inc.</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California (UCSF) Department of Ophthalmology</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Eye Surgeons</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shepard Eye Center</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Eye Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insight Vision Group</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danbury Eye Physicians and Surgeons PC</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Argus Research at Cape Coral Eye Center</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Retinal Center</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruce A Segal, M.D.</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Associates of Fort Myers</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Clinic at Shands Medical Plaza</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute, University of Miami</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Sight</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedEye Associates</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143-3693</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Eye Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virdi Eye Clinic</name>
      <address>
        <city>Rock Island</city>
        <state>Illinois</state>
        <zip>61201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentuckiana Institute for Eye Research at Bennett &amp; Bloom Eye Centers White House Office Complex</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins School of Medicine, Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Eye Research of Boston, Co.</name>
      <address>
        <city>Winchester</city>
        <state>Massachusetts</state>
        <zip>01890</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekwani Vision Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers-New Jersey Medical School</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Associates of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alterman, Modi &amp; Wolter</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Eye Care, LLP</name>
      <address>
        <city>Wantagh</city>
        <state>New York</state>
        <zip>11793</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Eye Ear Nose &amp; Throat Associates, PA</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James D. Branch, MD</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bergstrom Eye and Laser Clinic</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Good Samaritan Hospital - Devers Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Eye Center, P.C.</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; Christie and Associates, PC</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alkek Eye Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCT-Shah Research, LLC dba Discovery ClinicalTrials</name>
      <address>
        <city>Mission</city>
        <state>Texas</state>
        <zip>78572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Key Whitman Eye Center</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vistar Eye Center</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Eyecare Centre</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenatchee valley Hospital &amp; Clinics, Clinical research department</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Centers of Racine and Kenosha</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmologico de Buenos Aires Oftalmos</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1120AAN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires - Hospital</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Privada de Ojos</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Austral</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>B1629ODT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Oftalmologia Global</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Grupo Laser Visión</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000AZH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organización Médica de Investigación</name>
      <address>
        <city>Ciudad Autónoma de BuenosAires</city>
        <zip>C1015ABO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oftar Centro Privado de Oftalmologia</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACS Crichton Prof. Corp</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3E-7M8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority, Department of Ophthalmology &amp; Visual Sciences</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trimed Eye Center</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M455</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uptown Eye Specialists</name>
      <address>
        <city>Concord</city>
        <state>Ontario</state>
        <zip>L4K225</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galen Eye Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7K 6Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultant Centres Inc</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L4W1W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut De L'Oeil Des Laurentides</name>
      <address>
        <city>Boisbriand</city>
        <state>Quebec</state>
        <zip>J7J 2BJ</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique d' ophtalmologie Dr Saurel</name>
      <address>
        <city>Drummondville</city>
        <state>Quebec</state>
        <zip>J2C 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Clinic</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1V 1GS</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GOGiunta Ophtalmologie</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1G 2V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Oftalmologia Sandiego S.A.</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>0000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Oftalmologica Nacional Fundonal</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>110231</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Oftalmologica de Santander Foscal</name>
      <address>
        <city>Floridablanca</city>
        <state>Santander</state>
        <zip>680004</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A.</name>
      <address>
        <city>Cali</city>
        <zip>760001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocni klinika</name>
      <address>
        <city>Brno</city>
        <state>Jihlavska</state>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnicni Lekarna</name>
      <address>
        <city>Hradec Kralove</city>
        <state>Sokolska</state>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocni klinika Pardubice</name>
      <address>
        <city>Prague</city>
        <zip>53002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Menoufia University Hospital</name>
      <address>
        <city>Shibīn al-Kawm</city>
        <state>Cairo</state>
        <zip>32111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Kasr Al Ainy Cairo University Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ain Shams University Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Regensburg</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augen Zentrum Nordwest</name>
      <address>
        <city>Ahaus</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48683</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenärzte am St. Franziskus-Hospital</name>
      <address>
        <city>Munster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinisches Studienzentrum</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi G. D'Annunzio Chieti-Pescara</name>
      <address>
        <city>Chieti</city>
        <state>Abruzzo</state>
        <zip>66013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera-Polo Universitario San Paolo</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unità Operativa di Oculistica Ospedale San Raffaele S.r.l.</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria Della Misericordia</name>
      <address>
        <city>Perugia</city>
        <zip>06156</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>50586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Eye Specialists</name>
      <address>
        <city>Wellington</city>
        <zip>06011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore National Eye Centre</name>
      <address>
        <city>Singapore</city>
        <zip>168751</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Eye Care Centre</name>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pretoria Eye Institute</name>
      <address>
        <city>Arcadia</city>
        <state>Pretoria</state>
        <zip>0083</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali</name>
      <address>
        <city>Meselik</city>
        <state>Eskisehir</state>
        <zip>26480</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari</name>
      <address>
        <city>Pendik</city>
        <state>Istanbul</state>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali</name>
      <address>
        <city>Manisa</city>
        <zip>45030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Cosham</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Eye Pavilion</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH3 9HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hosp NHS Foundation Trust</name>
      <address>
        <city>Great Yarmouth</city>
        <zip>NR31 6LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Paul's Eye Unit Royal Liverpool&amp;Broadgreen, NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICORG</name>
      <address>
        <city>London</city>
        <zip>153-173</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough City Hospital Research and Development Department</name>
      <address>
        <city>Peterborough</city>
        <zip>PE39GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Egypt</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>New Zealand</country>
    <country>Singapore</country>
    <country>South Africa</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Saudi Arabia</country>
    <country>Thailand</country>
  </removed_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>April 29, 2021</results_first_submitted>
  <results_first_submitted_qc>July 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2021</results_first_posted>
  <disposition_first_submitted>August 20, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 20, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 28, 2019</disposition_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</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>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>June 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02250651/Prot_000.pdf</document_url>
    </provided_document>
    <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>October 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02250651/SAP_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 micrograms (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 (Day 1 to Week 15)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="176"/>
                <participants group_id="P3" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Sham or Bimatoprost SR</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="175"/>
                <participants group_id="P3" count="173"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="170"/>
                <participants group_id="P3" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <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="0"/>
              </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="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2 (Week 16 to Week 31)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
                <participants group_id="P2" count="168"/>
                <participants group_id="P3" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="162"/>
                <participants group_id="P3" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
              </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="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="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </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="3"/>
                <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="1"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 3 (Week 32 to Week 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="156"/>
                <participants group_id="P3" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="152"/>
                <participants group_id="P3" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </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="1"/>
                <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="1"/>
                <participants group_id="P2" count="2"/>
                <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="0"/>
                <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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) Population included 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="176"/>
            <count group_id="B2" value="176"/>
            <count group_id="B3" value="176"/>
            <count group_id="B4" value="528"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="176"/>
                    <count group_id="B3" value="176"/>
                    <count group_id="B4" value="528"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.8" spread="10.7"/>
                    <measurement group_id="B2" value="62.5" spread="12.7"/>
                    <measurement group_id="B3" value="61.4" spread="12.4"/>
                    <measurement group_id="B4" value="62.6" spread="12.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="176"/>
                    <count group_id="B3" value="176"/>
                    <count group_id="B4" value="528"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="259"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="176"/>
                    <count group_id="B3" value="176"/>
                    <count group_id="B4" value="528"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="104"/>
                    <measurement group_id="B4" value="335"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African and American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="18"/>
                  </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>
          <population>The number analyzed is the number of participants with data available for IOP at Baseline.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Hour 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="176"/>
                    <count group_id="B3" value="175"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.39" lower_limit="18.0" upper_limit="32.0"/>
                    <measurement group_id="B2" value="24.28" lower_limit="15.0" upper_limit="32.0"/>
                    <measurement group_id="B3" value="24.46" lower_limit="17.0" upper_limit="32.0"/>
                    <measurement group_id="B4" value="24.38" lower_limit="15.0" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="175"/>
                    <count group_id="B3" value="175"/>
                    <count group_id="B4" value="526"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.41" lower_limit="18.5" upper_limit="32.0"/>
                    <measurement group_id="B2" value="23.24" lower_limit="14.0" upper_limit="32.0"/>
                    <measurement group_id="B3" value="23.43" lower_limit="15.0" upper_limit="32.0"/>
                    <measurement group_id="B4" value="23.36" lower_limit="14.0" 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 Intraocular Pressure (IOP) in the Study Eye to 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 (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)</time_frame>
        <population>Participants from the ITT Population, all randomized 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>Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>millimeters of mercury (mmHg)</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="176"/>
                <count group_id="O2" value="176"/>
                <count group_id="O3" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline at Week 12, Hour 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.47" spread="0.30"/>
                    <measurement group_id="O2" value="-6.18" spread="0.30"/>
                    <measurement group_id="O3" value="-6.11" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12, Hour 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="168"/>
                    <count group_id="O3" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.16" spread="0.28"/>
                    <measurement group_id="O2" value="-6.72" spread="0.28"/>
                    <measurement group_id="O3" value="-6.36" spread="0.29"/>
                  </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 at Week 12, Hour 0: The 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 mmHg 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>0.3738</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.41</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>0.44</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 at Week 12, Hour 0: The 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 mmHg 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>0.8514</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>0.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>0.73</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 at Week 12, Hour 2: The 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 mmHg 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>0.0401</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>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.57</ci_lower_limit>
            <ci_upper_limit>-0.04</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 at Week 12, Hour 2: The 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 mmHg 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>0.3621</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.36</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>-1.12</ci_lower_limit>
            <ci_upper_limit>0.41</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="170"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.74" spread="0.27"/>
                    <measurement group_id="O2" value="16.92" spread="0.27"/>
                    <measurement group_id="O3" value="17.50" spread="0.27"/>
                  </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 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 mmHg 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>0.0382</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.48</ci_lower_limit>
            <ci_upper_limit>-0.04</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 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 mmHg 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>0.1133</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>0.14</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="170"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.09" spread="0.25"/>
                    <measurement group_id="O2" value="16.48" spread="0.25"/>
                    <measurement group_id="O3" value="17.19" 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 2: The 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 mmHg 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>0.0013</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>-0.43</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 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 mmHg 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>0.0364</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.38</ci_lower_limit>
            <ci_upper_limit>-0.05</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="172"/>
                <count group_id="O2" value="171"/>
                <count group_id="O3" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.05" spread="0.28"/>
                    <measurement group_id="O2" value="16.93" spread="0.28"/>
                    <measurement group_id="O3" value="17.51" spread="0.29"/>
                  </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 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 mmHg 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>0.2304</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.22</ci_lower_limit>
            <ci_upper_limit>0.29</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 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 mmHg 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>0.1272</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>0.17</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="172"/>
                <count group_id="O2" value="171"/>
                <count group_id="O3" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.13" spread="0.26"/>
                    <measurement group_id="O2" value="16.53" spread="0.26"/>
                    <measurement group_id="O3" value="17.18" spread="0.27"/>
                  </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 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 mmHg 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>0.0038</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.76</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 6, Hour 2: The 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 mmHg 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>0.0741</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>0.06</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="168"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.39" spread="0.30"/>
                    <measurement group_id="O2" value="17.68" spread="0.30"/>
                    <measurement group_id="O3" value="17.75" spread="0.30"/>
                  </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 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 mmHg 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>0.3738</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>0.44</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 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 mmHg 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>0.8514</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>0.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>0.73</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>Participants from the ITT Population, all randomized 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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="168"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.70" spread="0.28"/>
                    <measurement group_id="O2" value="17.15" spread="0.28"/>
                    <measurement group_id="O3" value="17.50" spread="0.29"/>
                  </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 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 mmHg 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>0.0401</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>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.57</ci_lower_limit>
            <ci_upper_limit>-0.04</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 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 mmHg 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>0.3621</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.36</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>-1.12</ci_lower_limit>
            <ci_upper_limit>0.41</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 (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)</time_frame>
        <population>Participants from the ITT Population, all randomized 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>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>Participants from the ITT Population, all randomized participants, with data available for analyses.</population>
          <units>mmHg</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="176"/>
                <count group_id="O2" value="176"/>
                <count group_id="O3" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline at Week 2, Hour 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.12" spread="0.27"/>
                    <measurement group_id="O2" value="-6.94" spread="0.27"/>
                    <measurement group_id="O3" value="-6.36" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 2, Hour 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.77" spread="0.25"/>
                    <measurement group_id="O2" value="-7.38" spread="0.25"/>
                    <measurement group_id="O3" value="-6.67" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 6, Hour 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.81" spread="0.28"/>
                    <measurement group_id="O2" value="-6.93" spread="0.28"/>
                    <measurement group_id="O3" value="-6.35" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 6, Hour 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.74" spread="0.26"/>
                    <measurement group_id="O2" value="-7.33" spread="0.26"/>
                    <measurement group_id="O3" value="-6.69" spread="0.27"/>
                  </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 at Week 2, Hour 0: The 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 mmHg 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>0.0382</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.48</ci_lower_limit>
            <ci_upper_limit>-0.04</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 at Week 2, Hour 0: The 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 mmHg 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>0.1133</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>0.14</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 at Week 2, Hour 2: The 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 mmHg 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>0.0013</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.10</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>-1.76</ci_lower_limit>
            <ci_upper_limit>-0.43</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 at Week 2, Hour 2: The 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 mmHg 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>0.0364</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.71</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>-1.38</ci_lower_limit>
            <ci_upper_limit>-0.05</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 at Week 6, Hour 0: The 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 mmHg 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>0.2304</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.22</ci_lower_limit>
            <ci_upper_limit>0.29</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 at Week 6, Hour 0: The 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 mmHg 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>0.1272</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>0.17</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 at Week 6, Hour 2: The 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 mmHg 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>0.0038</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-1.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</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 at Week 6, Hour 2: The 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 mmHg 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>0.0741</p_value>
            <method>MMRM</method>
            <param_type>Least-squares Mean Difference</param_type>
            <param_value>-0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>0.06</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>All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye [fellow-eye]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.</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="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal endothelial cell loss</sub_title>
                <description>12 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=3).</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <description>3 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=2, Bimatoprost SR 10 ug=1).</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <description>1 adverse event occurred in the study eye.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Pterygium</sub_title>
                <description>1 adverse event occurred in the study eye.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Corneal decompensation</sub_title>
                <description>1 adverse event occurred in the study eye.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <description>1 adverse event occurred in the study eye.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <description>1 adverse event occurred in the study eye.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <description>1 adverse event occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Product administered at inappropriate site</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <description>Number of participants at risk are male participants as this adverse event is specific to males.</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Breast cancer stage I</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Natural killer-cell leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Waldenstrom's macroglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Oropharyngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Follicular thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Small intestine carcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <description>Number of participants at risk are female participants as this adverse event is specific to females.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <description>Number of participants at risk are female participants as this adverse event is specific to females.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Penetrating aortic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </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="133" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="103" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="72" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <description>138 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=71, Bimatoprost SR 10 ug=48, and Timolol 0.5%=19); 86 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Corneal endothelial cell loss</sub_title>
                <description>50 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=38, Bimatoprost SR 10 ug=11, and Timolol 0.5%=1); 4 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <description>40 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=21, Bimatoprost SR 10 ug=11, and Timolol 0.5%=8); 16 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <description>26 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=21, Bimatoprost SR 10 ug=5).</description>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Foreign body sensation in eyes</sub_title>
                <description>37 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=18, Bimatoprost SR 10 ug=17, and Timolol 0.5%=2); 17 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <description>33 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=16, Bimatoprost SR 10 ug=10, and Timolol 0.5%=7); 31 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <description>42 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=14, Bimatoprost SR 10 ug=16, and Timolol 0.5%=12); 22 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <description>28 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=13, Bimatoprost SR 10 ug=8, and Timolol 0.5%=7); 26 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <description>26 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=13, Bimatoprost SR 10 ug=13); 13 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <description>28 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=12, Bimatoprost SR 10 ug=9, and Timolol 0.5%=7); 23 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Anterior chamber cell</sub_title>
                <description>19 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=12, Bimatoprost SR 10 ug=6, and Timolol 0.5%=1); 1 adverse event occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <description>15 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=11, Bimatoprost SR 10 ug=3, and Timolol 0.5%=1); 4 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <description>17 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=8); 1 adverse event occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <description>16 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=9, Bimatoprost SR 10 ug=6, and Timolol 0.5%=1); 12 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <description>17 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=7, Bimatoprost SR 10 ug=9, and Timolol 0.5%=1); 11 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <description>21 adverse events occurred in the study eye: (Bimatoprost SR 15 ug=7, Bimatoprost SR 10 ug=9, and Timolol 0.5%=5); 18 adverse events occurred in the fellow (non-study) eye.</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="175"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="173"/>
              </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/NCT02250651
org study id: 192024-092
secondary id: 2014-003186-24
nct id: NCT02250651
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 sustained-release (SR) in
      patients 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: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
time frame: Baseline (Up to 3 days prior to Day 1 at 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 (Up to 3 days prior to Day 1 at 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 micrograms (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%: Comparator
arm group type: Active Comparator
description: Both Eyes: 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
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%: Comparator
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%: Comparator
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: Margot Goodkin
role: Study Director
affiliation: Allergan
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country: Argentina
country: Canada
country: Colombia
country: Czechia
country: Egypt
country: Germany
country: Italy
country: Korea, Republic of
country: Malaysia
country: New Zealand
country: Singapore
country: South Africa
country: Turkey
country: United Kingdom
country: United States
country: Czech Republic
country: Netherlands
country: Portugal
country: Saudi Arabia
country: Thailand
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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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 