<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/NCT01664039</url>
  </required_header>
  <id_info>
    <org_study_id>RDG-11-244</org_study_id>
    <secondary_id>2012-002078-30</secondary_id>
    <nct_id>NCT01664039</nct_id>
  </id_info>
  <brief_title>An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®</brief_title>
  <official_title>Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular&#xD;
      pressure (IOP) and ocular surface and inflammatory biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6</measure>
    <time_frame>Baseline (Day 0), Month 6</time_frame>
    <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in IOP at Week 6 and Month 3</measure>
    <time_frame>Baseline (Day 0), Week 6, Month 3</time_frame>
    <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Reached Target IOP at Each Visit</measure>
    <time_frame>Week 6, Month 3, Month 6</time_frame>
    <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit</measure>
    <time_frame>Baseline (Day 0), Week 6, Month 3, Month 6</time_frame>
    <description>Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6</measure>
    <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
    <description>Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6</measure>
    <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
    <description>Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6</measure>
    <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
    <description>The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is &quot;None of the time&quot; and 4 is &quot;All of the time.&quot; A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6</measure>
    <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
    <description>TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>TRAVATAN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LUMIGAN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Travoprost 0.004% ophthalmic solution</intervention_name>
    <description>Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative</description>
    <arm_group_label>TRAVATAN</arm_group_label>
    <other_name>TRAVATAN®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bimatoprost 0.01% ophthalmic solution</intervention_name>
    <description>Ophthalmic solution containing benzalkonium chloride (BAK)</description>
    <arm_group_label>LUMIGAN</arm_group_label>
    <other_name>LUMIGAN®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye&#xD;
             and be treatment naïve to any glaucoma treatment.&#xD;
&#xD;
          -  Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which&#xD;
             would be the study eye.&#xD;
&#xD;
          -  IOP considered to be safe (in the opinion of the investigator), in both eyes, in such&#xD;
             a way that should assure clinical stability of vision and the optic nerve throughout&#xD;
             the study period.&#xD;
&#xD;
          -  Able to follow instructions and be willing and able to attend all study visits.&#xD;
&#xD;
          -  Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each&#xD;
             eye.&#xD;
&#xD;
          -  Must read, sign, and date an Ethics Committee-approved informed consent form.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known medical history of allergy, hypersensitivity or poor tolerance to any components&#xD;
             of the study medications to be used in this study that is deemed clinically&#xD;
             significant in the opinion of the Principal Investigator.&#xD;
&#xD;
          -  Any abnormality preventing reliable applanation tonometry in either eye.&#xD;
&#xD;
          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either&#xD;
             eye.&#xD;
&#xD;
          -  Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical&#xD;
             ocular corticosteroids.&#xD;
&#xD;
          -  History of ocular surface disease (dry eye) or current/prior use of dry eye&#xD;
             medications (either over-the counter or prescription medications).&#xD;
&#xD;
          -  Contact lens wear.&#xD;
&#xD;
          -  Intraocular conventional surgery or laser surgery in either eye that is less than&#xD;
             three months prior to the Screening Visit.&#xD;
&#xD;
          -  Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic&#xD;
             blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and&#xD;
             calcium channel blockers), which have not been on a stable course for at least 7 days&#xD;
             prior to Screening Visit or an anticipated change in the dosage during the course of&#xD;
             the study.&#xD;
&#xD;
          -  Women of childbearing potential not using reliable means of birth control, are&#xD;
             pregnant, or lactating.&#xD;
&#xD;
          -  Unwilling to risk the possibility of darkened iris or eyelash changes.&#xD;
&#xD;
          -  Participation in any other investigational study within 30 days prior to the Screening&#xD;
             Visit.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>June 19, 2015</results_first_submitted>
  <results_first_submitted_qc>June 19, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 14, 2015</results_first_posted>
  <last_update_submitted>July 13, 2015</last_update_submitted>
  <last_update_submitted_qc>July 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Ocular hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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>Bimatoprost</mesh_term>
    <mesh_term>Travoprost</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 2 study centers located in Slovenia.</recruitment_details>
      <pre_assignment_details>All enrolled subjects were randomized. This reporting group includes all randomized subjects (104). Note: 1 subject randomized to Travatan and 3 subjects randomized to Lumigan did not receive treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TRAVATAN</title>
          <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
        </group>
        <group group_id="P2">
          <title>LUMIGAN</title>
          <description>One drop to the study eye(s) once a day in the evening, for 6 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all randomized subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>TRAVATAN</title>
          <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
        </group>
        <group group_id="B2">
          <title>LUMIGAN</title>
          <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="52"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="104"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Under 60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 or more years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6</title>
        <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6</title>
          <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.66" spread="3.65"/>
                    <measurement group_id="O2" value="24.59" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 6, n=46,43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.61" spread="4.32"/>
                    <measurement group_id="O2" value="-7.35" spread="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in IOP at Week 6 and Month 3</title>
        <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Week 6, Month 3</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in IOP at Week 6 and Month 3</title>
          <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline at Week 6, n=46,46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.50" spread="3.80"/>
                    <measurement group_id="O2" value="-7.02" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 3, n=46,44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.96" spread="3.71"/>
                    <measurement group_id="O2" value="-7.82" spread="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Reached Target IOP at Each Visit</title>
        <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Week 6, Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Reached Target IOP at Each Visit</title>
          <description>IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6, n=46,46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6"/>
                    <measurement group_id="O2" value="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, n=46,44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7"/>
                    <measurement group_id="O2" value="70.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=46,43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9"/>
                    <measurement group_id="O2" value="67.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit</title>
        <description>Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Week 6, Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit</title>
          <description>Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Grade Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Grade Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Grade Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+2 Grade Change from Baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+2 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+2 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6</title>
        <description>Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6</title>
          <description>Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Grade Change from Baseline at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-1 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+1 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>+2 Grade Change from Baseline at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6</title>
        <description>Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6</title>
          <description>Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, -1 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, 0 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, +1 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, +2 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, -1 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, 0 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, +1 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, +2 Grade Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6</title>
        <description>The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is &quot;None of the time&quot; and 4 is &quot;All of the time.&quot; A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.</description>
        <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6</title>
          <description>The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is &quot;None of the time&quot; and 4 is &quot;All of the time.&quot; A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.</description>
          <population>This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="14.8"/>
                    <measurement group_id="O2" value="10.6" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 3, n=44,43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="12.2"/>
                    <measurement group_id="O2" value="0.0" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 6, n=44,42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="16.2"/>
                    <measurement group_id="O2" value="1.7" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6</title>
        <description>TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
        <time_frame>Baseline (Day 0), Month 3, Month 6</time_frame>
        <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>TRAVATAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
          <group group_id="O2">
            <title>LUMIGAN</title>
            <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6</title>
          <description>TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.</description>
          <population>This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, &quot;n&quot; is the number of subjects with non-missing values at the specific time point for each arm group, respectively.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="2.7"/>
                    <measurement group_id="O2" value="11.7" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 3, n=46,44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="5.3"/>
                    <measurement group_id="O2" value="-1.8" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 6, n=46,43</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="3.6"/>
                    <measurement group_id="O2" value="-2.2" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected for the duration of the study (Sep 2012 - Jun 2014). This analysis population includes all subjects who received at least 1 dose of either study treatment.</time_frame>
      <desc>An AE was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as both volunteered and elicited comments from the study subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>TRAVATAN</title>
          <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
        </group>
        <group group_id="E2">
          <title>LUMIGAN</title>
          <description>One drop to the study eye(s) once a day in the evening for 6 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Thromboendarterectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Brand Lead, Medical Affairs, Glaucoma</name_or_title>
      <organization>Alcon Research, Ltd</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.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/NCT01664039
org study id: RDG-11-244
secondary id: 2012-002078-30
nct id: NCT01664039
lead sponsor: 
has dmc: No
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular
      pressure (IOP) and ocular surface and inflammatory biomarkers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
time frame: Baseline (Day 0), Month 6
description: IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Mean Change From Baseline in IOP at Week 6 and Month 3
time frame: Baseline (Day 0), Week 6, Month 3
description: IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Percentage of Subjects Who Reached Target IOP at Each Visit
time frame: Week 6, Month 3, Month 6
description: IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
time frame: Baseline (Day 0), Week 6, Month 3, Month 6
description: Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
time frame: Baseline (Day 0), Month 3, Month 6
description: Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
time frame: Baseline (Day 0), Month 3, Month 6
description: Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
measure: Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
time frame: Baseline (Day 0), Month 3, Month 6
description: The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.
measure: Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
time frame: Baseline (Day 0), Month 3, Month 6
description: TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
arm group label: TRAVATAN
arm group type: Experimental
description: Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months
arm group label: LUMIGAN
arm group type: Active Comparator
description: Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months
intervention type: Drug
intervention name: Travoprost 0.004% ophthalmic solution
description: Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
arm group label: TRAVATAN
other name: TRAVATAN®
intervention type: Drug
intervention name: Bimatoprost 0.01% ophthalmic solution
description: Ophthalmic solution containing benzalkonium chloride (BAK)
arm group label: LUMIGAN
other name: LUMIGAN®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Bimatoprost
mesh term: Travoprost
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 