<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/NCT01711424</url>
  </required_header>
  <id_info>
    <org_study_id>MAF/AGN/OPH/DE/012</org_study_id>
    <nct_id>NCT01711424</nct_id>
  </id_info>
  <brief_title>An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease</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 is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine&#xD;
      clinical setting. Treatment decisions are made by the physician and reflect the physician's&#xD;
      current standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®</measure>
    <time_frame>Week 4</time_frame>
    <description>Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®</measure>
    <time_frame>Week 4</time_frame>
    <description>The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Break Up Time (TBUT)</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1209</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>OPTIVE PLUS®</arm_group_label>
    <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPTIVE PLUS®</intervention_name>
    <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
    <arm_group_label>OPTIVE PLUS®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with dry eye&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dry eye&#xD;
&#xD;
          -  Physician decision to treat with OPTIVE PLUS® in accordance with the physician's&#xD;
             standard practice&#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>Stuttgart</city>
        <state>Baden-Wuerttemberg</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>January 29, 2014</results_first_submitted>
  <results_first_submitted_qc>January 29, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 17, 2014</results_first_posted>
  <last_update_submitted>January 29, 2014</last_update_submitted>
  <last_update_submitted_qc>January 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2014</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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. There was no investigational drug administered in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OPTIVE PLUS®</title>
          <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician 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="1209"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1209"/>
              </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>OPTIVE PLUS®</title>
          <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1209"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;18 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" spread="15.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 to 30 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31 to 40 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>41 to 50 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51 to 60 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>61 to 70 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>71 to 80 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>81 to 90 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 91 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing Data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®</title>
        <description>Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
        <time_frame>Week 4</time_frame>
        <population>All participants with data available for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>OPTIVE PLUS®</title>
            <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®</title>
          <description>Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
          <population>All participants with data available for this outcome measure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®</title>
        <description>The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
        <time_frame>Week 4</time_frame>
        <population>All participants with data available for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>OPTIVE PLUS®</title>
            <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®</title>
          <description>The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).</description>
          <population>All participants with data available for this outcome measure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tear Break Up Time (TBUT)</title>
        <description>TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>All participants with complete data available for this outcome measure at Baseline and Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>OPTIVE PLUS®</title>
            <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Break Up Time (TBUT)</title>
          <description>TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.</description>
          <population>All participants with complete data available for this outcome measure at Baseline and Week 4.</population>
          <units>Seconds</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="2.0" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="2.0" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Schirmer Score</title>
        <description>The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>All participants with complete data available for this outcome measure at Baseline and Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>OPTIVE PLUS®</title>
            <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Schirmer Score</title>
          <description>The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.</description>
          <population>All participants with complete data available for this outcome measure at Baseline and Week 4.</population>
          <units>mm/5 min</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="307"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="1.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="1.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>OPTIVE PLUS®</title>
          <description>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</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="2" subjects_at_risk="1209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1209"/>
              </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="1209"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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/NCT01711424
org study id: MAF/AGN/OPH/DE/012
nct id: NCT01711424
lead sponsor: 
has dmc: No
This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine
      clinical setting. Treatment decisions are made by the physician and reflect the physician's
      current standard of care.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
time frame: Week 4
description: Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).
measure: Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
time frame: Week 4
description: The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).
measure: Tear Break Up Time (TBUT)
time frame: Baseline, Week 4
description: TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.
measure: Schirmer Score
time frame: Baseline, Week 4
description: The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.
arm group label: OPTIVE PLUS®
description: Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
intervention type: Drug
intervention name: OPTIVE PLUS®
description: Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
arm group label: OPTIVE PLUS®
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: Germany
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 