<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/NCT01732757</url>
  </required_header>
  <id_info>
    <org_study_id>GMA-LAS-12-023</org_study_id>
    <nct_id>NCT01732757</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis</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 efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™&#xD;
      (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular&#xD;
      itching associated with allergic conjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0 at 3 Minutes Post Challenge</time_frame>
    <description>Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score &lt;1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</measure>
    <time_frame>Day 0</time_frame>
    <description>Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Conjunctivitis, Allergic</condition>
  <arm_group>
    <arm_group_label>Lastacaft®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pataday™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alcaftadine 0.25%</intervention_name>
    <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
    <arm_group_label>Lastacaft®</arm_group_label>
    <other_name>Lastacaft®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olopatadine 0.2%</intervention_name>
    <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
    <arm_group_label>Pataday™</arm_group_label>
    <other_name>Pataday™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%</intervention_name>
    <description>One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
    <arm_group_label>Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)</arm_group_label>
    <other_name>Tears Naturale II</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of ocular allergies within the past 24 months.&#xD;
&#xD;
          -  Able to avoid wearing contact lenses for at least 72 hours prior to and during the&#xD;
             study trial period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any presence of active ocular infection or history of an ocular herpetic infection.&#xD;
&#xD;
          -  Ocular surgery within 3 months prior to the first visit or refractive surgery within&#xD;
             the past 6 months.&#xD;
&#xD;
          -  Have any planned surgery during the study or 30 days after the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 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>Memphis</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>November 27, 2013</results_first_submitted>
  <results_first_submitted_qc>November 27, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 14, 2014</results_first_posted>
  <last_update_submitted>November 27, 2013</last_update_submitted>
  <last_update_submitted_qc>November 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 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>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olopatadine Hydrochloride</mesh_term>
    <mesh_term>Dextrans</mesh_term>
    <mesh_term>Alcaftadine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lastacaft®</title>
          <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="P2">
          <title>Pataday™</title>
          <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
          <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lastacaft®</title>
          <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="B2">
          <title>Pataday™</title>
          <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
          <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="52"/>
            <count group_id="B4" value="157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" spread="13.78"/>
                    <measurement group_id="B2" value="38.7" spread="15.10"/>
                    <measurement group_id="B3" value="34.7" spread="12.58"/>
                    <measurement group_id="B4" value="37.2" spread="13.88"/>
                  </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="32"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0</title>
        <description>Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
        <time_frame>Day 0 at 3 Minutes Post Challenge</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0</title>
          <description>Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.582"/>
                    <measurement group_id="O2" value="0.76" spread="0.752"/>
                    <measurement group_id="O3" value="2.00" spread="1.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0</title>
        <description>Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0</title>
          <description>Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.663"/>
                    <measurement group_id="O2" value="0.79" spread="0.725"/>
                    <measurement group_id="O3" value="2.08" spread="1.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.724"/>
                    <measurement group_id="O2" value="0.71" spread="0.774"/>
                    <measurement group_id="O3" value="1.89" spread="1.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0</title>
        <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score &lt;1.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0</title>
          <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score &lt;1.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Percentage of Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                    <measurement group_id="O2" value="65.4"/>
                    <measurement group_id="O3" value="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="53.8"/>
                    <measurement group_id="O3" value="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                    <measurement group_id="O2" value="61.5"/>
                    <measurement group_id="O3" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0</title>
        <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0</title>
          <description>Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Percentage of Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1"/>
                    <measurement group_id="O2" value="26.9"/>
                    <measurement group_id="O3" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="26.9"/>
                    <measurement group_id="O3" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="32.7"/>
                    <measurement group_id="O3" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0</title>
        <description>Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0</title>
          <description>Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Percentage of Subject Eyes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                    <measurement group_id="O2" value="34.3"/>
                    <measurement group_id="O3" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.1"/>
                    <measurement group_id="O2" value="24.0"/>
                    <measurement group_id="O3" value="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="20.8"/>
                    <measurement group_id="O3" value="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="7.7"/>
                    <measurement group_id="O3" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="6.7"/>
                    <measurement group_id="O3" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="5.1"/>
                    <measurement group_id="O3" value="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.3"/>
                    <measurement group_id="O3" value="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.73" spread="0.887"/>
                    <measurement group_id="O2" value="1.61" spread="0.867"/>
                    <measurement group_id="O3" value="2.17" spread="0.731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="0.844"/>
                    <measurement group_id="O2" value="1.81" spread="0.877"/>
                    <measurement group_id="O3" value="2.17" spread="0.784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="0.854"/>
                    <measurement group_id="O2" value="1.89" spread="0.886"/>
                    <measurement group_id="O3" value="2.22" spread="0.830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.889"/>
                    <measurement group_id="O2" value="1.47" spread="0.887"/>
                    <measurement group_id="O3" value="2.10" spread="0.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.845"/>
                    <measurement group_id="O2" value="1.71" spread="0.912"/>
                    <measurement group_id="O3" value="2.12" spread="0.832"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="0.831"/>
                    <measurement group_id="O2" value="1.78" spread="0.913"/>
                    <measurement group_id="O3" value="2.13" spread="0.903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" spread="0.842"/>
                    <measurement group_id="O2" value="1.53" spread="0.815"/>
                    <measurement group_id="O3" value="2.04" spread="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="0.820"/>
                    <measurement group_id="O2" value="1.70" spread="0.839"/>
                    <measurement group_id="O3" value="2.04" spread="0.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.837"/>
                    <measurement group_id="O2" value="1.78" spread="0.874"/>
                    <measurement group_id="O3" value="2.09" spread="0.837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="0.433"/>
                    <measurement group_id="O2" value="0.27" spread="0.350"/>
                    <measurement group_id="O3" value="0.51" spread="0.511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.576"/>
                    <measurement group_id="O2" value="0.51" spread="0.562"/>
                    <measurement group_id="O3" value="0.76" spread="0.691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.679"/>
                    <measurement group_id="O2" value="0.56" spread="0.634"/>
                    <measurement group_id="O3" value="0.96" spread="0.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.48"/>
                    <measurement group_id="O2" value="0.3" spread="0.54"/>
                    <measurement group_id="O3" value="0.8" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.51"/>
                    <measurement group_id="O2" value="0.5" spread="0.70"/>
                    <measurement group_id="O3" value="0.9" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.51"/>
                    <measurement group_id="O2" value="0.6" spread="0.85"/>
                    <measurement group_id="O3" value="0.7" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
        <description>Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.</description>
        <time_frame>Day 0</time_frame>
        <population>All randomized subjects with data at this time point</population>
        <group_list>
          <group group_id="O1">
            <title>Lastacaft®</title>
            <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Pataday™</title>
            <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
            <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0</title>
          <description>Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.</description>
          <population>All randomized subjects with data at this time point</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.40"/>
                    <measurement group_id="O2" value="0.4" spread="0.59"/>
                    <measurement group_id="O3" value="0.9" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.58"/>
                    <measurement group_id="O2" value="0.5" spread="0.77"/>
                    <measurement group_id="O3" value="0.8" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.57"/>
                    <measurement group_id="O2" value="0.6" spread="0.83"/>
                    <measurement group_id="O3" value="0.7" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Lastacaft®</title>
          <description>One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="E2">
          <title>Pataday™</title>
          <description>One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)</title>
          <description>One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.</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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </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/NCT01732757
org study id: GMA-LAS-12-023
nct id: NCT01732757
lead sponsor: 
has dmc: No
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™
      (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular
      itching associated with allergic conjunctivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
time frame: Day 0 at 3 Minutes Post Challenge
description: Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
measure: Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
time frame: Day 0
description: Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
measure: Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
time frame: Day 0
description: Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.
measure: Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
time frame: Day 0
description: Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.
measure: Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
time frame: Day 0
description: Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).
measure: Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.
measure: Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.
measure: Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.
measure: Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.
measure: Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.
measure: Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
time frame: Day 0
description: Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.
arm group label: Lastacaft®
arm group type: Active Comparator
description: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
arm group label: Pataday™
arm group type: Active Comparator
description: One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
arm group label: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
arm group type: Placebo Comparator
description: One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
intervention type: Drug
intervention name: Alcaftadine 0.25%
description: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
arm group label: Lastacaft®
other name: Lastacaft®
intervention type: Drug
intervention name: Olopatadine 0.2%
description: One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
arm group label: Pataday™
other name: Pataday™
intervention type: Drug
intervention name: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
description: One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
arm group label: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
other name: Tears Naturale II
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Olopatadine Hydrochloride
mesh term: Dextrans
mesh term: Alcaftadine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 