<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/NCT01735214</url>
  </required_header>
  <id_info>
    <org_study_id>MAF/AGN/OPH/GLA/037</org_study_id>
    <nct_id>NCT01735214</nct_id>
  </id_info>
  <brief_title>An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, observational study of changing from any IOP-lowering treatment&#xD;
      to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open&#xD;
      Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies&#xD;
      with the physician according to their standard practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2013</start_date>
  <completion_date type="Actual">April 10, 2014</completion_date>
  <primary_completion_date type="Actual">April 10, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Intraocular Pressure (IOP) in the Right Eye</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Intraocular Pressure (IOP) in the Left Eye</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Continue the New Treatment After 12 Weeks</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Assessment of Adherence to New Treatment Using a 4-Point Scale</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Assessment of Efficacy Using a 5-Point Scale</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reaching Individual IOP Target After 12 Weeks</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">358</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Patients with POAG or OHT</arm_group_label>
    <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prostaglandin Analogue -Containing IOP-Lowering Therapy</intervention_name>
    <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
    <arm_group_label>Patients with POAG or OHT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        POAG or OHT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)&#xD;
&#xD;
          -  Previously prescribed any IOP-lowering therapy which has been stopped and a new&#xD;
             prostaglandin analogue -containing IOP-lowering therapy started&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.</citation>
    <PMID>28458511</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>April 10, 2015</results_first_submitted>
  <results_first_submitted_qc>April 10, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 27, 2015</results_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</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>Ocular Hypertension</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patients With POAG or OHT</title>
          <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="358"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="358"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patients With POAG or OHT</title>
          <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="358"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18 to 30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31 to 40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>41 to 50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51 to 60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>61 to 70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>71 to 80 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>81 to 90 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                  </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 Right Eye</title>
        <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participant with IOP data at Baseline and Week 12 for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intraocular Pressure (IOP) in the Right Eye</title>
          <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
          <population>All participant with IOP data at Baseline and Week 12 for analysis.</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="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale</title>
        <description>The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
        <time_frame>12 Weeks</time_frame>
        <population>All participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale</title>
          <description>The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
          <population>All participants with available data.</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale</title>
        <description>The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
        <time_frame>12 Weeks</time_frame>
        <population>All participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale</title>
          <description>The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.</description>
          <population>All participants with data available for analysis.</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks</title>
        <time_frame>12 Weeks</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks</title>
          <population>All participants.</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Continue the New Treatment After 12 Weeks</title>
        <time_frame>12 Weeks</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Continue the New Treatment After 12 Weeks</title>
          <population>All participants</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Assessment of Adherence to New Treatment Using a 4-Point Scale</title>
        <description>The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.</description>
        <time_frame>12 Weeks</time_frame>
        <population>All Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Assessment of Adherence to New Treatment Using a 4-Point Scale</title>
          <description>The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.</description>
          <population>All Participants</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not Applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Equal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Better</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Assessment of Efficacy Using a 5-Point Scale</title>
        <description>The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.</description>
        <time_frame>12 Weeks</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Assessment of Efficacy Using a 5-Point Scale</title>
          <description>The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.</description>
          <population>All participants.</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IOP lower than target</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reached target IOP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IOP decreased but target NOT reached</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IOP increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reaching Individual IOP Target After 12 Weeks</title>
        <time_frame>12 Weeks</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reaching Individual IOP Target After 12 Weeks</title>
          <population>All participants</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="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Intraocular Pressure (IOP) in the Left Eye</title>
        <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participant with IOP data at Baseline and Week 12 for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With POAG or OHT</title>
            <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intraocular Pressure (IOP) in the Left Eye</title>
          <description>IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.</description>
          <population>All participant with IOP data at Baseline and Week 12 for analysis.</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="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Patients With POAG or OHT</title>
          <description>Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.</description>
        </group>
      </group_list>
      <serious_events>
        <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="358"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 13.0</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="23" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperemia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="358"/>
              </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>Vice President Medical Affairs,</name_or_title>
      <organization>Allergan, Inc</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/NCT01735214
org study id: MAF/AGN/OPH/GLA/037
nct id: NCT01735214
lead sponsor: 
has dmc: No
This study is a prospective, observational study of changing from any IOP-lowering treatment
      to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open
      Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies
      with the physician according to their standard practice.
observational model: Case-Only
time perspective: Prospective
measure: Change From Baseline in Intraocular Pressure (IOP) in the Right Eye
time frame: Baseline, Week 12
description: IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
measure: Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
time frame: Baseline, Week 12
description: IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
measure: Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
time frame: 12 Weeks
description: The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
measure: Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
time frame: 12 Weeks
description: The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
measure: Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
time frame: 12 Weeks
measure: Percentage of Participants Who Continue the New Treatment After 12 Weeks
time frame: 12 Weeks
measure: Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
time frame: 12 Weeks
description: The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.
measure: Physician Assessment of Efficacy Using a 5-Point Scale
time frame: 12 Weeks
description: The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.
measure: Percentage of Participants Reaching Individual IOP Target After 12 Weeks
time frame: 12 Weeks
arm group label: Patients with POAG or OHT
description: Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
intervention type: Drug
intervention name: Prostaglandin Analogue -Containing IOP-Lowering Therapy
description: Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
arm group label: Patients with POAG or OHT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: Turkey
citation: Tamcelik N, Izgi B, Temel A, Yildirim N, Okka M, Ozcan A, Yuksel N, Elgin U, Altan C, Ozer B. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.
PMID: 28458511
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Glaucoma, Open-Angle
mesh term: Hypertension
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 