<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/NCT01698554</url>
  </required_header>
  <id_info>
    <org_study_id>192024-046</org_study_id>
    <secondary_id>2012-003007-35</secondary_id>
    <nct_id>NCT01698554</nct_id>
  </id_info>
  <brief_title>Bimatoprost in the Treatment of Eyelash Hypotrichosis</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 will evaluate the safety and efficacy of bimatoprost solution formulation A&#xD;
      compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash&#xD;
      hypotrichosis (inadequate eyelashes).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)</measure>
    <time_frame>Baseline, Month 4</time_frame>
    <description>The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)</measure>
    <time_frame>Baseline, Month 4</time_frame>
    <description>Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA</measure>
    <time_frame>Baseline Month 4</time_frame>
    <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA</measure>
    <time_frame>Baseline, Month 4</time_frame>
    <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)</measure>
    <time_frame>Month 4</time_frame>
    <description>Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: &quot;Overall, how satisfied are you with your eyelashes?&quot; using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">464</enrollment>
  <condition>Idiopathic Eyelash Hypotrichosis</condition>
  <arm_group>
    <arm_group_label>bimatoprost formulation A solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bimatoprost solution 0.03 %</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vehicle of bimatoprost formulation A solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vehicle of bimatoprost solution 0.03 %</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bimatoprost formulation A solution</intervention_name>
    <description>Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
    <arm_group_label>bimatoprost formulation A solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bimatoprost solution 0.03 %</intervention_name>
    <description>Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
    <arm_group_label>bimatoprost solution 0.03 %</arm_group_label>
    <other_name>LATISSE®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vehicle of bimatoprost formulation A solution</intervention_name>
    <description>Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
    <arm_group_label>vehicle of bimatoprost formulation A solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vehicle of bimatoprost solution 0.03 %</intervention_name>
    <description>Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
    <arm_group_label>vehicle of bimatoprost solution 0.03 %</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Damage to eyelid area (scarring) that may prevent growth of eyelashes&#xD;
&#xD;
          -  Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe&#xD;
             dry eye)&#xD;
&#xD;
          -  Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery,&#xD;
             blepharoplasty) during the 3 months prior to screening&#xD;
&#xD;
          -  Current eyelash implants of any kind&#xD;
&#xD;
          -  Eyelash tint or dye application within 2 months of baseline&#xD;
&#xD;
          -  Eyelash extensions application within 3 months of baseline&#xD;
&#xD;
          -  Use of eyelash growth products within 6 months of baseline&#xD;
&#xD;
          -  Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents,&#xD;
             etc) within 6 months prior to baseline.&#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>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>January 27, 2015</results_first_submitted>
  <results_first_submitted_qc>January 27, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 10, 2015</results_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</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>Hypotrichosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bimatoprost</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bimatoprost Formulation A Solution</title>
          <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="P2">
          <title>Bimatoprost Solution 0.03 %</title>
          <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="P3">
          <title>Vehicle of Bimatoprost Formulation A Solution</title>
          <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="P4">
          <title>Vehicle of Bimatoprost Solution 0.03 %</title>
          <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="157"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="73"/>
                <participants group_id="P4" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Miscellaneous Reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bimatoprost Formulation A Solution</title>
          <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="B2">
          <title>Bimatoprost Solution 0.03 %</title>
          <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="B3">
          <title>Vehicle of Bimatoprost Formulation A Solution</title>
          <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="B4">
          <title>Vehicle of Bimatoprost Solution 0.03 %</title>
          <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="B5">
          <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="153"/>
            <count group_id="B2" value="157"/>
            <count group_id="B3" value="75"/>
            <count group_id="B4" value="79"/>
            <count group_id="B5" value="464"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;45 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 to 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="55"/>
                    <measurement group_id="B5" value="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="60"/>
                  </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="150"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="457"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)</title>
        <description>The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.</description>
        <time_frame>Baseline, Month 4</time_frame>
        <population>Intent-to-treat (ITT) Population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost Formulation A Solution</title>
            <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost Solution 0.03 %</title>
            <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle of Bimatoprost Formulation A Solution</title>
            <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O4">
            <title>Vehicle of Bimatoprost Solution 0.03 %</title>
            <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)</title>
          <description>The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.</description>
          <population>Intent-to-treat (ITT) Population included all randomized 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="153"/>
                <count group_id="O2" value="157"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4"/>
                    <measurement group_id="O2" value="83.4"/>
                    <measurement group_id="O3" value="24.0"/>
                    <measurement group_id="O4" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)</title>
        <description>Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)</description>
        <time_frame>Baseline, Month 4</time_frame>
        <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost Formulation A Solution</title>
            <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost Solution 0.03 %</title>
            <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle of Bimatoprost Formulation A Solution</title>
            <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O4">
            <title>Vehicle of Bimatoprost Solution 0.03 %</title>
            <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)</title>
          <description>Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)</description>
          <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="157"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" spread="0.856"/>
                    <measurement group_id="O2" value="5.97" spread="0.789"/>
                    <measurement group_id="O3" value="5.90" spread="0.812"/>
                    <measurement group_id="O4" value="6.03" spread="0.852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" spread="0.888"/>
                    <measurement group_id="O2" value="1.62" spread="0.955"/>
                    <measurement group_id="O3" value="0.08" spread="0.442"/>
                    <measurement group_id="O4" value="0.05" spread="0.482"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA</title>
        <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).</description>
        <time_frame>Baseline Month 4</time_frame>
        <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost Formulation A Solution</title>
            <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost Solution 0.03 %</title>
            <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle of Bimatoprost Formulation A Solution</title>
            <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O4">
            <title>Vehicle of Bimatoprost Solution 0.03 %</title>
            <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA</title>
          <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).</description>
          <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.400"/>
                    <measurement group_id="O2" value="0.82" spread="0.404"/>
                    <measurement group_id="O3" value="0.76" spread="0.333"/>
                    <measurement group_id="O4" value="0.81" spread="0.380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline At Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.359"/>
                    <measurement group_id="O2" value="0.64" spread="0.392"/>
                    <measurement group_id="O3" value="0.02" spread="0.196"/>
                    <measurement group_id="O4" value="0.03" spread="0.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA</title>
        <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).</description>
        <time_frame>Baseline, Month 4</time_frame>
        <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost Formulation A Solution</title>
            <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost Solution 0.03 %</title>
            <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle of Bimatoprost Formulation A Solution</title>
            <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O4">
            <title>Vehicle of Bimatoprost Solution 0.03 %</title>
            <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA</title>
          <description>Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).</description>
          <population>Participants from the ITT Population, all randomized participants, with data available for analysis.</population>
          <units>intensity units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.33" spread="24.024"/>
                    <measurement group_id="O2" value="147.39" spread="24.934"/>
                    <measurement group_id="O3" value="147.44" spread="22.323"/>
                    <measurement group_id="O4" value="145.79" spread="26.670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.98" spread="15.719"/>
                    <measurement group_id="O2" value="-24.78" spread="16.417"/>
                    <measurement group_id="O3" value="-2.78" spread="10.443"/>
                    <measurement group_id="O4" value="0.17" spread="10.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)</title>
        <description>Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: &quot;Overall, how satisfied are you with your eyelashes?&quot; using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.</description>
        <time_frame>Month 4</time_frame>
        <population>ITT Population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bimatoprost Formulation A Solution</title>
            <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O2">
            <title>Bimatoprost Solution 0.03 %</title>
            <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle of Bimatoprost Formulation A Solution</title>
            <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
          <group group_id="O4">
            <title>Vehicle of Bimatoprost Solution 0.03 %</title>
            <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)</title>
          <description>Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: &quot;Overall, how satisfied are you with your eyelashes?&quot; using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.</description>
          <population>ITT Population included all randomized 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="153"/>
                <count group_id="O2" value="157"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2"/>
                    <measurement group_id="O2" value="65.0"/>
                    <measurement group_id="O3" value="28.0"/>
                    <measurement group_id="O4" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bimatoprost Formulation A Solution</title>
          <description>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="E2">
          <title>Bimatoprost Solution 0.03 %</title>
          <description>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="E3">
          <title>Vehicle of Bimatoprost Formulation A Solution</title>
          <description>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
        <group group_id="E4">
          <title>Vehicle of Bimatoprost Solution 0.03 %</title>
          <description>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</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="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Meningitis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <description>female population</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="7" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="157"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, 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/NCT01698554
org study id: 192024-046
secondary id: 2012-003007-35
nct id: NCT01698554
lead sponsor: 
has dmc: No
This study will evaluate the safety and efficacy of bimatoprost solution formulation A
      compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash
      hypotrichosis (inadequate eyelashes).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
time frame: Baseline, Month 4
description: The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
measure: Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
time frame: Baseline, Month 4
description: Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)
measure: Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
time frame: Baseline Month 4
description: Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).
measure: Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
time frame: Baseline, Month 4
description: Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
measure: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)
time frame: Month 4
description: Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.
arm group label: bimatoprost formulation A solution
arm group type: Experimental
description: Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: bimatoprost solution 0.03 %
arm group type: Active Comparator
description: Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: vehicle of bimatoprost formulation A solution
arm group type: Placebo Comparator
description: Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: vehicle of bimatoprost solution 0.03 %
arm group type: Placebo Comparator
description: Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
intervention type: Drug
intervention name: bimatoprost formulation A solution
description: Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: bimatoprost formulation A solution
intervention type: Drug
intervention name: bimatoprost solution 0.03 %
description: Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: bimatoprost solution 0.03 %
other name: LATISSE®
intervention type: Drug
intervention name: vehicle of bimatoprost formulation A solution
description: Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: vehicle of bimatoprost formulation A solution
intervention type: Drug
intervention name: vehicle of bimatoprost solution 0.03 %
description: Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
arm group label: vehicle of bimatoprost solution 0.03 %
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Hypotrichosis
mesh term: Bimatoprost
mesh term: Pharmaceutical Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 