<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/NCT03248440</url>
  </required_header>
  <id_info>
    <org_study_id>SUN-131-03</org_study_id>
    <nct_id>NCT03248440</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion</brief_title>
  <acronym>SUNRISE</acronym>
  <official_title>A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUN-131-03)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Senju USA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Senju USA, Inc.</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>
      This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%&#xD;
      TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The&#xD;
      purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared&#xD;
      with placebo TDS in the treatment of a chalazion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">August 17, 2018</completion_date>
  <primary_completion_date type="Actual">August 17, 2018</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>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1</measure>
    <time_frame>Baseline to Day 15 ± 1</time_frame>
    <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1</measure>
    <time_frame>Baseline to Day 15 ± 1</time_frame>
    <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>Chalazion</condition>
  <arm_group>
    <arm_group_label>SUN-131 1.5% TDS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo TDS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUN-131 1.5% TDS</intervention_name>
    <description>SUN-131 1.5% TDS will be worn for 14 days</description>
    <arm_group_label>SUN-131 1.5% TDS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo TDS</intervention_name>
    <description>No active substance; Placebo TDS will be worn each day for 14 days</description>
    <arm_group_label>Placebo TDS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged ≥ 6 years of either sex and of any race&#xD;
&#xD;
          2. Subjects with a diagnosis of a single chalazion&#xD;
&#xD;
          3. Subjects with chalazion erythema score of ≥ 1&#xD;
&#xD;
          4. Normal eyelid function without active signs of eye and eyelid infection in either eye.&#xD;
&#xD;
          5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid&#xD;
&#xD;
          6. Avoid wearing contact lenses in the study eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal&#xD;
             surrounding lid tissue, associated loss of tissues).&#xD;
&#xD;
          2. History of chalazion incision and curettage in study eyelid.&#xD;
&#xD;
          3. Multiple chalazia in any one eyelid.&#xD;
&#xD;
          4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.&#xD;
&#xD;
          5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic&#xD;
             dermatitis, etc.) where the study drug will be applied.&#xD;
&#xD;
          6. Diagnosed with glaucoma in either eye.&#xD;
&#xD;
          7. History of steroid-induced elevation of IOP.&#xD;
&#xD;
          8. Female subjects who are pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Prescott</city>
        <state>Arizona</state>
        <zip>86301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
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        <city>Largo</city>
        <state>Florida</state>
        <zip>33773</zip>
        <country>United States</country>
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    <facility>
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        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
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  <location>
    <facility>
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        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
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        <state>Georgia</state>
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        <country>United States</country>
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        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
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        <state>Illinois</state>
        <zip>60415</zip>
        <country>United States</country>
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        <city>Glenview</city>
        <state>Illinois</state>
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        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
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        <state>Kansas</state>
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        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
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        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
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        <state>Kentucky</state>
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        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
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        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55420</zip>
        <country>United States</country>
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        <state>Missouri</state>
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        <country>United States</country>
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        <state>Missouri</state>
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        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
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        <state>Nevada</state>
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        <country>United States</country>
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      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
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        <country>United States</country>
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        <zip>11793</zip>
        <country>United States</country>
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        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
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        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
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        <state>North Carolina</state>
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        <country>United States</country>
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        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
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        <state>Ohio</state>
        <zip>45247</zip>
        <country>United States</country>
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        <state>Ohio</state>
        <zip>45040</zip>
        <country>United States</country>
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        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
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        <country>United States</country>
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        <state>Pennsylvania</state>
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        <state>Pennsylvania</state>
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        <country>United States</country>
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        <country>United States</country>
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        <country>United States</country>
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        <country>United States</country>
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      <name>SUN-131-03 Investigational Site</name>
      <address>
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        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
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        <zip>84117</zip>
        <country>United States</country>
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      <address>
        <city>Exmore</city>
        <state>Virginia</state>
        <zip>23350</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUN-131-03 Investigational Site</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>July 7, 2021</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2021</results_first_posted>
  <disposition_first_submitted>September 17, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 3, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 5, 2021</disposition_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</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>Chalazion</mesh_term>
  </condition_browse>
  <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>August 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03248440/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo TDS</title>
          <description>Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
        </group>
        <group group_id="P2">
          <title>SUN-131 1.5% TDS</title>
          <description>SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all randomized subjects who received the study drug. Intent-to-treat (ITT) population included all randomized subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo TDS</title>
          <description>Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
        </group>
        <group group_id="B2">
          <title>SUN-131 1.5% TDS</title>
          <description>SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</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="131"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="263"/>
          </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="46.8" spread="17.00"/>
                    <measurement group_id="B2" value="49.0" spread="16.03"/>
                    <measurement group_id="B3" value="47.9" spread="16.52"/>
                  </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="82"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multi-racial (no primary race)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="131"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1</title>
        <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
        <time_frame>Baseline to Day 15 ± 1</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo TDS</title>
            <description>Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>SUN-131 1.5% TDS</title>
            <description>SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1</title>
          <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.579</p_value>
            <method>2-sided Pearson's chi-square</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1</title>
        <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
        <time_frame>Baseline to Day 15 ± 1</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo TDS</title>
            <description>Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>SUN-131 1.5% TDS</title>
            <description>SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1</title>
          <description>Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.082</p_value>
            <method>2-sided Pearson's chi-square</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3).</time_frame>
      <desc>A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo TDS</title>
          <description>Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</description>
        </group>
        <group group_id="E2">
          <title>SUN-131 1.5% TDS</title>
          <description>SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.</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="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Conjunctival follicles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Ocular hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Pinguecula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Eyelid disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Eyelid pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </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>The Principal Investigator will not disclose information regarding this clinical investigation, or publish results of the investigation without authorization from Senju USA, Inc.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Takahiro Ogawa, PhD</name_or_title>
      <organization>Senju USA, Inc.</organization>
      <phone>+1 818 719 7190</phone>
      <email>ogawataka@senju-usa.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/NCT03248440
org study id: SUN-131-03
nct id: NCT03248440
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%
      TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The
      purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared
      with placebo TDS in the treatment of a chalazion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
time frame: Baseline to Day 15 ± 1
description: Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
measure: The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1
time frame: Baseline to Day 15 ± 1
description: Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
arm group label: SUN-131 1.5% TDS
arm group type: Experimental
arm group label: Placebo TDS
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SUN-131 1.5% TDS
description: SUN-131 1.5% TDS will be worn for 14 days
arm group label: SUN-131 1.5% TDS
intervention type: Drug
intervention name: Placebo TDS
description: No active substance; Placebo TDS will be worn each day for 14 days
arm group label: Placebo TDS
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Chalazion
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