<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/NCT03012165</url>
  </required_header>
  <id_info>
    <org_study_id>ADX-102-AC-004</org_study_id>
    <nct_id>NCT03012165</nct_id>
  </id_info>
  <brief_title>A Study of ADX-102 in Subjects With Allergic Conjunctivitis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aldeyra Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aldeyra Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the&#xD;
      Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102&#xD;
      Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic&#xD;
      Conjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</measure>
    <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
    <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</measure>
    <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
    <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</measure>
    <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
    <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Conjunctivitis, Allergic</condition>
  <arm_group>
    <arm_group_label>ADX-102 Ophthalmic Drops (0.5%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ADX-102 Ophthalmic Drops (0.1%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle of ADX-102 Ophthalmic Drops</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of ADX-102 Ophthalmic Drops</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADX-102 Ophthalmic Drops (0.5%)</intervention_name>
    <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
    <arm_group_label>ADX-102 Ophthalmic Drops (0.5%)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADX-102 Ophthalmic Drops (0.1%)</intervention_name>
    <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
    <arm_group_label>ADX-102 Ophthalmic Drops (0.1%)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle of ADX-102 Ophthalmic Drops</intervention_name>
    <description>Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
    <arm_group_label>Vehicle of ADX-102 Ophthalmic Drops</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be at least 18 years of age of either gender and any race&#xD;
&#xD;
          -  have a positive history of ocular allergies and a positive skin test reaction to a&#xD;
             seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog&#xD;
             dander, dust mites, cockroach) as confirmed by an allergic skin test within the past&#xD;
             24 months&#xD;
&#xD;
          -  have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using&#xD;
             an ETDRS chart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have known contraindications or sensitivities to the use of the investigational&#xD;
             product or any of its components&#xD;
&#xD;
          -  have any ocular condition that, in the opinion of the investigator, could affect the&#xD;
             subject's safety or trial parameters (including but not limited to narrow angle&#xD;
             glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis,&#xD;
             pterygium or a diagnosis of dry eye)&#xD;
&#xD;
          -  have had ocular surgical intervention within three (3) months prior to Visit 1 or&#xD;
             during the study and/or a history of refractive surgery within the past six (6) months&#xD;
&#xD;
          -  have a known history of retinal detachment, diabetic retinopathy, or active retinal&#xD;
             disease&#xD;
&#xD;
          -  have the presence of an active ocular infection (bacterial, viral or fungal) or&#xD;
             positive history of an ocular herpetic infection at any visit&#xD;
&#xD;
          -  be a female who is currently pregnant, planning a pregnancy, lactating, not using a&#xD;
             medically acceptable form of birth control throughout the study duration and for 14&#xD;
             days prior to the installation of investigational product, or has a positive urine&#xD;
             pregnancy test at Visit 1&#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>Eye Care Centers Management</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silverstein Eye Centers</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye Clinical Research</name>
      <address>
        <city>Mason</city>
        <state>Ohio</state>
        <zip>45040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia Eye Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>November 17, 2022</results_first_submitted>
  <results_first_submitted_qc>December 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2023</results_first_posted>
  <disposition_first_submitted>April 6, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>April 6, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 10, 2018</disposition_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADX-102</keyword>
  <keyword>Allergic Conjunctivitis</keyword>
  <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>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03012165/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03012165/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ADX-102 Ophthalmic Drops (0.5%)</title>
          <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
        </group>
        <group group_id="P2">
          <title>ADX-102 Ophthalmic Drops (0.1%)</title>
          <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
        </group>
        <group group_id="P3">
          <title>Vehicle of ADX-102 Ophthalmic Drops</title>
          <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="49"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ADX-102 Ophthalmic Drops (0.5%)</title>
          <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
        </group>
        <group group_id="B2">
          <title>ADX-102 Ophthalmic Drops (0.1%)</title>
          <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
        </group>
        <group group_id="B3">
          <title>Vehicle of ADX-102 Ophthalmic Drops</title>
          <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="50"/>
            <count group_id="B4" value="154"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="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="40"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="57"/>
                  </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="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="141"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" 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="34"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Iris Color (Right Eye)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hazel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Green</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gray</title>
              <category_list>
                <category>
                  <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Iris Color (Left Eye)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hazel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Green</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gray</title>
              <category_list>
                <category>
                  <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
        <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
        <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
        <population>Intent to treat population with observed data only.</population>
        <group_list>
          <group group_id="O1">
            <title>ADX-102 (0.5%)</title>
            <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
          </group>
          <group group_id="O2">
            <title>ADX-102 (0.1%)</title>
            <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
          <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
          <population>Intent to treat population with observed data only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.020" spread="0.9821"/>
                    <measurement group_id="O2" value="2.398" spread="0.8290"/>
                    <measurement group_id="O3" value="2.515" spread="0.9661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
        <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
        <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
        <population>Intent to treat population with observed data only.</population>
        <group_list>
          <group group_id="O1">
            <title>ADX-102 (0.5%)</title>
            <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
          </group>
          <group group_id="O2">
            <title>ADX-102 (0.1%)</title>
            <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
          <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
          <population>Intent to treat population with observed data only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.662" spread="1.0085"/>
                    <measurement group_id="O2" value="1.801" spread="0.9601"/>
                    <measurement group_id="O3" value="1.985" spread="0.9768"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
        <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
        <time_frame>Efficacy assessment period (Day 1 through Day 15), Day 15 reported.</time_frame>
        <population>Intent to treat with observed data only.</population>
        <group_list>
          <group group_id="O1">
            <title>ADX-102 (0.5%)</title>
            <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
          </group>
          <group group_id="O2">
            <title>ADX-102 (0.1%)</title>
            <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.</title>
          <description>Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.</description>
          <population>Intent to treat with observed data only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.152" spread="0.9799"/>
                    <measurement group_id="O2" value="1.434" spread="0.9773"/>
                    <measurement group_id="O3" value="1.551" spread="1.0433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was captured for approximately 5 weeks for each subject during clinical trial participation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ADX-102 Ophthalmic Drops (0.5%)</title>
          <description>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.</description>
        </group>
        <group group_id="E2">
          <title>ADX-102 Ophthalmic Drops (0.1%)</title>
          <description>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.&#xD;
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.</description>
        </group>
        <group group_id="E3">
          <title>Vehicle of ADX-102 Ophthalmic Drops</title>
          <description>Vehicle of ADX-102 Ophthalmic Drops&#xD;
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.</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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
              </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>Sr. Director, Clinical Operations</name_or_title>
      <organization>Aldeyra Therapeutics, Inc.</organization>
      <phone>781-257-3063</phone>
      <email>bcavanagh@aldeyra.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/NCT03012165
org study id: ADX-102-AC-004
nct id: NCT03012165
lead sponsor: 
collaborator: 
has dmc: No
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the
      Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102
      Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic
      Conjunctivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
description: Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
measure: Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
description: Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
measure: Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
description: Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
arm group label: ADX-102 Ophthalmic Drops (0.5%)
arm group type: Experimental
description: ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
arm group label: ADX-102 Ophthalmic Drops (0.1%)
arm group type: Experimental
description: ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
arm group label: Vehicle of ADX-102 Ophthalmic Drops
arm group type: Placebo Comparator
description: Vehicle of ADX-102 Ophthalmic Drops
intervention type: Drug
intervention name: ADX-102 Ophthalmic Drops (0.5%)
description: ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
arm group label: ADX-102 Ophthalmic Drops (0.5%)
intervention type: Drug
intervention name: ADX-102 Ophthalmic Drops (0.1%)
description: ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
arm group label: ADX-102 Ophthalmic Drops (0.1%)
intervention type: Drug
intervention name: Vehicle of ADX-102 Ophthalmic Drops
description: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
arm group label: Vehicle of ADX-102 Ophthalmic Drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Ophthalmic Solutions
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 