<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/NCT02251613</url>
  </required_header>
  <id_info>
    <org_study_id>13-100-0009</org_study_id>
    <secondary_id>UMIN000013943</secondary_id>
    <nct_id>NCT02251613</nct_id>
  </id_info>
  <brief_title>Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan</brief_title>
  <official_title>Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness and safety of Olopatadine&#xD;
      Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05%&#xD;
      in a population of healthy, adult Japanese patients (20 years of age or older) with a history&#xD;
      of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to&#xD;
      receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic&#xD;
      solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with&#xD;
      Japanese cedar pollen will be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Ocular Itching at 7 Minutes Post-CAC, Day 1</measure>
    <time_frame>Day 1, 7 minutes post-CAC</time_frame>
    <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1</measure>
    <time_frame>Day 1, 20 minutes post-CAC</time_frame>
    <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Olopatadine (right or left, randomized)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epinastine (fellow eye)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olopatadine HCl ophthalmic solution, 0.1%</intervention_name>
    <arm_group_label>Olopatadine (right or left, randomized)</arm_group_label>
    <other_name>PATANOL®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinastine HCl ophthalmic solution, 0.05%</intervention_name>
    <arm_group_label>Epinastine (fellow eye)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be Japanese and live in Japan;&#xD;
&#xD;
          -  History of allergic conjunctivitis;&#xD;
&#xD;
          -  Positive skin test reaction to Japanese cedar at Visit 1;&#xD;
&#xD;
          -  Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;&#xD;
&#xD;
          -  Able and willing to avoid all disallowed medications during the specified period;&#xD;
&#xD;
          -  Able to discontinue wearing contact lenses during the specified period;&#xD;
&#xD;
          -  Sign Informed Consent;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to the study drug or compounds;&#xD;
&#xD;
          -  Any ocular condition that, in the opinion of the investigator, could affect the&#xD;
             patient's safety;&#xD;
&#xD;
          -  Ocular surgical intervention within 3 months or refractive surgery within 6 months&#xD;
             prior to the start of the study;&#xD;
&#xD;
          -  Presence of active ocular infection;&#xD;
&#xD;
          -  Use of disallowed medications as specified in the protocol;&#xD;
&#xD;
          -  Pregnant, nursing, or planning to become pregnant during the study;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsunemitsu Senta</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Japan, Ltd.</affiliation>
  </overall_official>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>January 26, 2015</results_first_submitted>
  <results_first_submitted_qc>January 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 9, 2015</results_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olopatadine Hydrochloride</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Epinastine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 study site located in Japan.</recruitment_details>
      <pre_assignment_details>All subjects qualifying for treatment at Visit 3 were randomized. This reporting group includes all randomized participants (50).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall</title>
          <description>Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This reporting group includes all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>20-29 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Ocular Itching at 7 Minutes Post-CAC, Day 1</title>
        <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).</description>
        <time_frame>Day 1, 7 minutes post-CAC</time_frame>
        <population>This analysis population includes all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Olopatadine 0.1%</title>
            <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</description>
          </group>
          <group group_id="O2">
            <title>Epinastine 0.05%</title>
            <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Ocular Itching at 7 Minutes Post-CAC, Day 1</title>
          <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).</description>
          <population>This analysis population includes all randomized participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <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>
              <units>eyes</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.31"/>
                    <measurement group_id="O2" value="0.37" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1</title>
        <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).</description>
        <time_frame>Day 1, 20 minutes post-CAC</time_frame>
        <population>This analysis population includes all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Olopatadine 0.1%</title>
            <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</description>
          </group>
          <group group_id="O2">
            <title>Epinastine 0.05%</title>
            <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1</title>
          <description>A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).</description>
          <population>This analysis population includes all randomized participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <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>
              <units>eyes</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.88"/>
                    <measurement group_id="O2" value="1.12" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected for the duration of the study (December, 2013 - January, 2014). This analysis group includes all randomized subjects who received at least 1 dose of study medication.</time_frame>
      <desc>An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment, except for skin test and allergic symptom caused by CAC. AEs were obtained through solicited and spontaneous comments from the subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Olopatadine 0.1%</title>
          <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</description>
        </group>
        <group group_id="E2">
          <title>Epinastine 0.05%</title>
          <description>Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.</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>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" 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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hironari Sakaguchi, Phase IV Clinical &amp; Regulatory Affairs, Japan</name_or_title>
      <organization>Alcon Japan, Ltd.</organization>
      <phone>+81 3 6899 5054</phone>
      <email>Hironari.Sakaguchi@alcon.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/NCT02251613
org study id: 13-100-0009
secondary id: UMIN000013943
nct id: NCT02251613
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness and safety of Olopatadine
      Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05%
      in a population of healthy, adult Japanese patients (20 years of age or older) with a history
      of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to
      receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic
      solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with
      Japanese cedar pollen will be performed.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
time frame: Day 1, 7 minutes post-CAC
description: A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
measure: Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
time frame: Day 1, 20 minutes post-CAC
description: A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).
arm group label: Olopatadine (right or left, randomized)
arm group type: Experimental
description: Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
arm group label: Epinastine (fellow eye)
arm group type: Active Comparator
description: Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
intervention type: Drug
intervention name: Olopatadine HCl ophthalmic solution, 0.1%
arm group label: Olopatadine (right or left, randomized)
other name: PATANOL®
intervention type: Drug
intervention name: Epinastine HCl ophthalmic solution, 0.05%
arm group label: Epinastine (fellow eye)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tsunemitsu Senta
role: Study Director
affiliation: Alcon Japan, Ltd.
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Olopatadine Hydrochloride
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
mesh term: Epinastine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 