<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/NCT01685242</url>
  </required_header>
  <id_info>
    <org_study_id>12-100-0006</org_study_id>
    <nct_id>NCT01685242</nct_id>
  </id_info>
  <brief_title>A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle</brief_title>
  <official_title>A Single-Center, Double-Masked, Randomization, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aciex Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aciex Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%&#xD;
      compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in&#xD;
      the conjunctival allergen challenge (CAC) model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>3, 5, 7 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Itching at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>3, 5, 7 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conjunctival Redness at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ciliary Redness at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episcleral Redness at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemosis at Onset of Action (15 Minutes)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyelid Swelling at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tearing at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rhinorrhea at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Pruritus at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Congestion at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Composite Score at Onset of Action (15 Minutes Post-dose)</measure>
    <time_frame>7, 15, 20 minutes post-CAC</time_frame>
    <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability of Study Medication at Visit 3A</measure>
    <time_frame>upon instillation, 1 minute and 2 minutes post instillation</time_frame>
    <description>Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>AC-170 0.24%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AC-170 0%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AC-170 0.24%</intervention_name>
    <description>1 drop in each eye at 2 separate times during a 14 day period</description>
    <arm_group_label>AC-170 0.24%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AC-170 0%</intervention_name>
    <description>1 drop in each eye at 2 separate times during a 14 day period</description>
    <arm_group_label>AC-170 0%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  positive bilateral conjunctival allergen challenge (CAC)reaction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known contraindications or sensitivities to the study medication or its components&#xD;
&#xD;
          -  any ocular condition that, in the opinion of the investigator, could affect the&#xD;
             subjects safety trial parameters&#xD;
&#xD;
          -  use of disallowed medication during the period indicated prior to the enrollment or&#xD;
             during 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>Dawn DeCastro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andover Eye Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edward Meier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eye Care Associates of Greater Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stacey Ackerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philadelphia Eye Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eugene Protzko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seidenberg Protzko Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>June 26, 2017</results_first_submitted>
  <results_first_submitted_qc>September 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2017</results_first_posted>
  <disposition_first_submitted>April 30, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>April 30, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 19, 2015</disposition_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</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>Cetirizine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from one site in the US.</recruitment_details>
      <pre_assignment_details>There were 100 subjects enrolled, 4 subjects discontinued, and 96 subjects completed the study. Participant flow and baseline characteristics are presented for the 100 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AC-170 0.24%</title>
          <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
        </group>
        <group group_id="P2">
          <title>AC-170 0%</title>
          <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AC-170 0.24%</title>
          <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
        </group>
        <group group_id="B2">
          <title>AC-170 0%</title>
          <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </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="39.5" spread="17.32"/>
                    <measurement group_id="B2" value="38.1" spread="14.56"/>
                    <measurement group_id="B3" value="38.8" spread="15.93"/>
                  </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="37"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
        <time_frame>3, 5, 7 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="0.940"/>
                    <measurement group_id="O2" value="2.69" spread="0.663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.938"/>
                    <measurement group_id="O2" value="2.74" spread="0.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="0.971"/>
                    <measurement group_id="O2" value="2.53" spread="1.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
        <time_frame>3, 5, 7 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.911"/>
                    <measurement group_id="O2" value="2.38" spread="0.722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.931"/>
                    <measurement group_id="O2" value="2.43" spread="0.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.863"/>
                    <measurement group_id="O2" value="2.11" spread="0.872"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.664"/>
                    <measurement group_id="O2" value="2.27" spread="0.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.635"/>
                    <measurement group_id="O2" value="2.34" spread="0.486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.663"/>
                    <measurement group_id="O2" value="2.32" spread="0.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Conjunctival Redness at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Redness at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="0.429"/>
                    <measurement group_id="O2" value="1.98" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="0.388"/>
                    <measurement group_id="O2" value="2.09" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="0.484"/>
                    <measurement group_id="O2" value="2.09" spread="0.458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="0.647"/>
                    <measurement group_id="O2" value="2.19" spread="0.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.18" spread="0.686"/>
                    <measurement group_id="O2" value="2.33" spread="0.501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="0.680"/>
                    <measurement group_id="O2" value="2.30" spread="0.531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ciliary Redness at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ciliary Redness at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.481"/>
                    <measurement group_id="O2" value="1.98" spread="0.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" spread="0.505"/>
                    <measurement group_id="O2" value="2.06" spread="0.419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.90" spread="0.500"/>
                    <measurement group_id="O2" value="2.05" spread="0.430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" spread="0.645"/>
                    <measurement group_id="O2" value="2.31" spread="0.453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="0.596"/>
                    <measurement group_id="O2" value="2.35" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.627"/>
                    <measurement group_id="O2" value="2.35" spread="0.525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Episcleral Redness at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Episcleral Redness at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" spread="0.460"/>
                    <measurement group_id="O2" value="2.03" spread="0.461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" spread="0.461"/>
                    <measurement group_id="O2" value="2.13" spread="0.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="0.488"/>
                    <measurement group_id="O2" value="2.11" spread="0.477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.557"/>
                    <measurement group_id="O2" value="1.24" spread="0.635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.656"/>
                    <measurement group_id="O2" value="1.44" spread="0.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.718"/>
                    <measurement group_id="O2" value="1.51" spread="0.803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemosis at Onset of Action (15 Minutes)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Chemosis at Onset of Action (15 Minutes)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.379"/>
                    <measurement group_id="O2" value="1.03" spread="0.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="0.403"/>
                    <measurement group_id="O2" value="1.28" spread="0.611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="0.525"/>
                    <measurement group_id="O2" value="1.43" spread="0.705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.68"/>
                    <measurement group_id="O2" value="1.1" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.86"/>
                    <measurement group_id="O2" value="1.2" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.80"/>
                    <measurement group_id="O2" value="1.1" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eyelid Swelling at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Eyelid Swelling at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.67"/>
                    <measurement group_id="O2" value="1.0" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.74"/>
                    <measurement group_id="O2" value="1.0" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.77"/>
                    <measurement group_id="O2" value="1.0" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.72"/>
                    <measurement group_id="O2" value="1.0" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.92"/>
                    <measurement group_id="O2" value="1.0" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.92"/>
                    <measurement group_id="O2" value="0.9" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tearing at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Tearing at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.67"/>
                    <measurement group_id="O2" value="1.0" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.85"/>
                    <measurement group_id="O2" value="0.9" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.84"/>
                    <measurement group_id="O2" value="0.8" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.68"/>
                    <measurement group_id="O2" value="1.3" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.98"/>
                    <measurement group_id="O2" value="1.6" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.95"/>
                    <measurement group_id="O2" value="1.5" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rhinorrhea at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Rhinorrhea at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.77"/>
                    <measurement group_id="O2" value="1.1" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.94"/>
                    <measurement group_id="O2" value="1.3" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.01"/>
                    <measurement group_id="O2" value="1.2" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.58"/>
                    <measurement group_id="O2" value="0.8" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.82"/>
                    <measurement group_id="O2" value="1.0" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.79"/>
                    <measurement group_id="O2" value="0.9" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Pruritus at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Pruritus at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.76"/>
                    <measurement group_id="O2" value="0.6" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.97"/>
                    <measurement group_id="O2" value="0.8" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.79"/>
                    <measurement group_id="O2" value="0.7" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.82"/>
                    <measurement group_id="O2" value="0.8" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.11"/>
                    <measurement group_id="O2" value="1.3" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.09"/>
                    <measurement group_id="O2" value="1.3" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.77"/>
                    <measurement group_id="O2" value="0.8" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.98"/>
                    <measurement group_id="O2" value="1.1" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.10"/>
                    <measurement group_id="O2" value="1.1" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.85"/>
                    <measurement group_id="O2" value="1.2" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.03"/>
                    <measurement group_id="O2" value="1.6" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.06"/>
                    <measurement group_id="O2" value="1.5" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Congestion at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Congestion at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.03"/>
                    <measurement group_id="O2" value="1.1" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.16"/>
                    <measurement group_id="O2" value="1.3" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.09"/>
                    <measurement group_id="O2" value="1.4" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>%participants with at least 1 nasal symp</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.2"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.7"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Composite Score at Onset of Action (15 Minutes Post-dose)</title>
        <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
        <time_frame>7, 15, 20 minutes post-CAC</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Composite Score at Onset of Action (15 Minutes Post-dose)</title>
          <description>A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.</description>
          <population>Intent to Treat (ITT)</population>
          <units>%participants with at least 1 nasal symp</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>7 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6"/>
                    <measurement group_id="O2" value="91.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6"/>
                    <measurement group_id="O2" value="93.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerability of Study Medication at Visit 3A</title>
        <description>Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.</description>
        <time_frame>upon instillation, 1 minute and 2 minutes post instillation</time_frame>
        <population>Intent to Treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>AC-170 0.24%</title>
            <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
          <group group_id="O2">
            <title>AC-170 0%</title>
            <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability of Study Medication at Visit 3A</title>
          <description>Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.</description>
          <population>Intent to Treat (ITT)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Upon instillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.42"/>
                    <measurement group_id="O2" value="1.0" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 minute post-instillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.44"/>
                    <measurement group_id="O2" value="1.2" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 minutes post-instillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.44"/>
                    <measurement group_id="O2" value="1.0" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.</time_frame>
      <desc>Throughout the visits, staff collected all Adverse Events reported, elicited or observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>AC-170 0.24%</title>
          <description>AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period</description>
        </group>
        <group group_id="E2">
          <title>AC-170 0%</title>
          <description>AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Acuity Reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Punctate Keratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rheumatoid Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pharyngeal Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President</name_or_title>
      <organization>Nicox Ophthalmics Inc.</organization>
      <phone>817-529-9315</phone>
      <email>bergamini@nicox.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/NCT01685242
org study id: 12-100-0006
nct id: NCT01685242
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%
      compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in
      the conjunctival allergen challenge (CAC) model.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 3, 5, 7 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
measure: Ocular Itching at Onset of Action (15 Minutes Post-dose)
time frame: 3, 5, 7 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
measure: Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
measure: Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
measure: Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
measure: Ciliary Redness at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
measure: Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
measure: Episcleral Redness at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
measure: Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
measure: Chemosis at Onset of Action (15 Minutes)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
measure: Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
measure: Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
measure: Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
measure: Tearing at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
measure: Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
measure: Rhinorrhea at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
measure: Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
measure: Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
measure: Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
measure: Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
measure: Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
measure: Nasal Congestion at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
measure: Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
measure: Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
time frame: 7, 15, 20 minutes post-CAC
description: A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
measure: Tolerability of Study Medication at Visit 3A
time frame: upon instillation, 1 minute and 2 minutes post instillation
description: Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
arm group label: AC-170 0.24%
arm group type: Experimental
arm group label: AC-170 0%
arm group type: Placebo Comparator
intervention type: Drug
intervention name: AC-170 0.24%
description: 1 drop in each eye at 2 separate times during a 14 day period
arm group label: AC-170 0.24%
intervention type: Drug
intervention name: AC-170 0%
description: 1 drop in each eye at 2 separate times during a 14 day period
arm group label: AC-170 0%
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Dawn DeCastro, MD
role: Principal Investigator
affiliation: Andover Eye Associates
last name: Edward Meier, MD
role: Principal Investigator
affiliation: Eye Care Associates of Greater Cincinnati
last name: Stacey Ackerman, MD
role: Principal Investigator
affiliation: Philadelphia Eye Associates
last name: Eugene Protzko, MD
role: Principal Investigator
affiliation: Seidenberg Protzko Eye Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Cetirizine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 