<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/NCT03231969</url>
  </required_header>
  <id_info>
    <org_study_id>BOFT-0117/DR-CAC</org_study_id>
    <nct_id>NCT03231969</nct_id>
  </id_info>
  <brief_title>A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model</brief_title>
  <official_title>A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faes Farma, S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Faes Farma, S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to&#xD;
      vehicle for the treatment of the signs and symptoms of allergic conjunctivitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">October 11, 2017</completion_date>
  <primary_completion_date type="Actual">October 11, 2017</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Itching</measure>
    <time_frame>The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).</time_frame>
    <description>The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Bilastine 0.2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilastine Ophthalmic solution 0.2%&#xD;
1 drop in each eye at 3 separate times during a 25 day period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilastine 0.4%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilastine Ophthalmic solution 0.4%&#xD;
1 drop in each eye at 3 separate times during a 25 day period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilastine 0.6%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilastine Ophthalmic solution 0.6%&#xD;
1 drop in each eye at 3 separate times during a 25 day period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilastine 0%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of Bilastine Ophthalmic Solution&#xD;
1 drop in each eye at 3 separate times during a 25 day period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine 0.2%</intervention_name>
    <description>1 drop in each eye at 3 separate times during a 25 day period.</description>
    <arm_group_label>Bilastine 0.2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine 0.4%</intervention_name>
    <description>1 drop in each eye at 3 separate times during a 25 day period.</description>
    <arm_group_label>Bilastine 0.4%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine 0.6%</intervention_name>
    <description>1 drop in each eye at 3 separate times during a 25 day period.</description>
    <arm_group_label>Bilastine 0.6%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine 0%</intervention_name>
    <description>1 drop in each eye at 3 separate times during a 25 day period.</description>
    <arm_group_label>Bilastine 0%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  be at least 18 years old&#xD;
&#xD;
          -  be willing and able to avoid all disallowed medications and contact lenses&#xD;
&#xD;
          -  must have a pregnancy test if of childbearing potential&#xD;
&#xD;
          -  must be able to read an eye chart from 10 feet away&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  must not have any allergies to the study medications&#xD;
&#xD;
          -  must not have any ocular or non ocular condition that investigator feels will&#xD;
             interfere with study parameters&#xD;
&#xD;
          -  must not have used immunotherapy in the last 2 years&#xD;
&#xD;
          -  must not have used an investigational drug or device in the past 30 days or&#xD;
             concurrently enrolled in another investigational trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ora Clinical Research Center</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>October 2021</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>March 9, 2021</results_first_submitted>
  <results_first_submitted_qc>October 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 24, 2021</results_first_posted>
  <disposition_first_submitted>October 25, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>October 28, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 24, 2021</disposition_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03231969/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bilastine 0.2%</title>
          <description>Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="P2">
          <title>Bilastine 0.4%</title>
          <description>Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="P3">
          <title>Bilastine 0.6%</title>
          <description>Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="P4">
          <title>Bilastine 0%</title>
          <description>Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 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="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bilastine 0.2%</title>
          <description>Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="B2">
          <title>Bilastine 0.4%</title>
          <description>Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="B3">
          <title>Bilastine 0.6%</title>
          <description>Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="B4">
          <title>Bilastine 0%</title>
          <description>Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="30"/>
            <count group_id="B5" value="121"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="50.4" spread="10.7"/>
                    <measurement group_id="B2" value="47.0" spread="13.95"/>
                    <measurement group_id="B3" value="51.8" spread="13.4"/>
                    <measurement group_id="B4" value="48.3" spread="13.24"/>
                    <measurement group_id="B5" value="49.4" spread="12.8"/>
                  </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="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="55"/>
                  </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="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="102"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ocular Itching- Baseline</title>
          <description>The primary efficacy measure was ocular itching evaluated by the subject post-CAC at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment), using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.The baseline measures for this primary outcome will be the &quot;pre-CAC&quot; values (pre-Conjunctival Allergen Challenge).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Visit 4b: Pre- CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.058" spread="0.2043"/>
                    <measurement group_id="B2" value="0.000" spread="0.0000"/>
                    <measurement group_id="B3" value="0.048" spread="0.1981"/>
                    <measurement group_id="B4" value="0.025" spread="0.1006"/>
                    <measurement group_id="B5" value="0.03275" spread="0.12575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5b: Pre- CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.000" spread="0.0000"/>
                    <measurement group_id="B2" value="0.000" spread="0.0000"/>
                    <measurement group_id="B3" value="0.033" spread="0.1826"/>
                    <measurement group_id="B4" value="0.033" spread="0.1826"/>
                    <measurement group_id="B5" value="0.0165" spread="0.0913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Pre- CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.000" spread="0.0000"/>
                    <measurement group_id="B2" value="0.000" spread="0.0000"/>
                    <measurement group_id="B3" value="0.000" spread="0.0000"/>
                    <measurement group_id="B4" value="0.000" spread="0.0000"/>
                    <measurement group_id="B5" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching</title>
        <description>The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.</description>
        <time_frame>The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bilastine 0.2%</title>
            <description>Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
          </group>
          <group group_id="O2">
            <title>Bilastine 0.4%</title>
            <description>Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
          </group>
          <group group_id="O3">
            <title>Bilastine 0.6%</title>
            <description>Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
          </group>
          <group group_id="O4">
            <title>Bilastine 0% (Vehicle)</title>
            <description>Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching</title>
          <description>The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.</description>
          <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="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 4b: 3 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.908" spread="0.7809"/>
                    <measurement group_id="O2" value="1.925" spread="0.9449"/>
                    <measurement group_id="O3" value="1.177" spread="1.0332"/>
                    <measurement group_id="O4" value="2.758" spread="0.7146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4b: 5 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.075" spread="0.7828"/>
                    <measurement group_id="O2" value="2.117" spread="0.9531"/>
                    <measurement group_id="O3" value="1.218" spread="1.1268"/>
                    <measurement group_id="O4" value="3.017" spread="0.5979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4b: 7 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.092" spread="0.7698"/>
                    <measurement group_id="O2" value="2.100" spread="1.0760"/>
                    <measurement group_id="O3" value="1.218" spread="1.1157"/>
                    <measurement group_id="O4" value="2.917" spread="0.5884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5b: 3 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.397" spread="1.1050"/>
                    <measurement group_id="O2" value="1.250" spread="0.8872"/>
                    <measurement group_id="O3" value="0.708" spread="0.8908"/>
                    <measurement group_id="O4" value="2.558" spread="0.8032"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5b: 5 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.466" spread="0.9300"/>
                    <measurement group_id="O2" value="1.464" spread="0.9592"/>
                    <measurement group_id="O3" value="0.817" spread="1.0503"/>
                    <measurement group_id="O4" value="2.642" spread="0.7505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5b: 7 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.379" spread="0.8573"/>
                    <measurement group_id="O2" value="1.518" spread="1.0340"/>
                    <measurement group_id="O3" value="0.742" spread="0.9837"/>
                    <measurement group_id="O4" value="2.642" spread="0.7704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: 3 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.679" spread="0.6662"/>
                    <measurement group_id="O2" value="0.732" spread="0.9127"/>
                    <measurement group_id="O3" value="0.392" spread="0.5749"/>
                    <measurement group_id="O4" value="2.542" spread="0.8384"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: 5 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.920" spread="0.7235"/>
                    <measurement group_id="O2" value="1.143" spread="0.9987"/>
                    <measurement group_id="O3" value="0.558" spread="0.6355"/>
                    <measurement group_id="O4" value="2.592" spread="0.8343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: 7 minutes Post-CAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" spread="0.7454"/>
                    <measurement group_id="O2" value="1.214" spread="0.9421"/>
                    <measurement group_id="O3" value="0.583" spread="0.6706"/>
                    <measurement group_id="O4" value="2.483" spread="0.9024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.791</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.203</ci_lower_limit>
            <ci_upper_limit>-0.378</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.851</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.263</ci_lower_limit>
            <ci_upper_limit>-0.439</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.545</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.954</ci_lower_limit>
            <ci_upper_limit>-1.135</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.208</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.639</ci_lower_limit>
            <ci_upper_limit>-0.778</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.245</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.679</ci_lower_limit>
            <ci_upper_limit>-0.811</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.846</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.273</ci_lower_limit>
            <ci_upper_limit>-1.418</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.696</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.080</ci_lower_limit>
            <ci_upper_limit>-1.312</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.617</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.001</ci_lower_limit>
            <ci_upper_limit>-1.232</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.009</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.387</ci_lower_limit>
            <ci_upper_limit>-1.630</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bilastine 0.2%</title>
          <description>Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="E2">
          <title>Bilastine 0.4%</title>
          <description>Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="E3">
          <title>Bilastine 0.6%</title>
          <description>Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
        <group group_id="E4">
          <title>Bilastine 0%</title>
          <description>Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA version 20.0</default_vocab>
        <default_assessment>Non-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="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Acuity Reduced</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Corneal Deposits</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Eye Discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Macular Fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </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>Nieves Fernández, MD, PhD</name_or_title>
      <organization>Faes Farma</organization>
      <phone>+34 94 481 83 00</phone>
      <email>nfernandez@faes.es</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/NCT03231969
org study id: BOFT-0117/DR-CAC
nct id: NCT03231969
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to
      vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Ocular Itching
time frame: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
description: The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
arm group label: Bilastine 0.2%
arm group type: Experimental
description: Bilastine Ophthalmic solution 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0.4%
arm group type: Experimental
description: Bilastine Ophthalmic solution 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0.6%
arm group type: Experimental
description: Bilastine Ophthalmic solution 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0%
arm group type: Placebo Comparator
description: Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 3 separate times during a 25 day period.
intervention type: Drug
intervention name: Bilastine 0.2%
description: 1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0.2%
intervention type: Drug
intervention name: Bilastine 0.4%
description: 1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0.4%
intervention type: Drug
intervention name: Bilastine 0.6%
description: 1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0.6%
intervention type: Drug
intervention name: Bilastine 0%
description: 1 drop in each eye at 3 separate times during a 25 day period.
arm group label: Bilastine 0%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 