<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/NCT02988882</url>
  </required_header>
  <id_info>
    <org_study_id>OTX-15-002</org_study_id>
    <nct_id>NCT02988882</nct_id>
  </id_info>
  <brief_title>OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis</brief_title>
  <official_title>A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ocular Therapeutix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ocular Therapeutix, Inc.</source>
  <brief_summary>
    <textblock>
      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone&#xD;
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the&#xD;
      treatment of the signs and symptoms of chronic allergic conjunctivitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">April 27, 2016</completion_date>
  <primary_completion_date type="Actual">April 27, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</measure>
    <time_frame>3 minutes</time_frame>
    <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6</measure>
    <time_frame>5 minutes</time_frame>
    <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</measure>
    <time_frame>7 minutes</time_frame>
    <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Chronic Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>OTX-DP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PV</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PV (placebo drug delivery vehicle)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>OTX-DP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Vehicle</intervention_name>
    <arm_group_label>PV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a positive history of ocular allergies and a positive skin test reaction to a&#xD;
             perennial allergen and a seasonal allergen&#xD;
&#xD;
          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of&#xD;
             instillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of refractive surgery (including LASIK procedures) within the past 2 years&#xD;
&#xD;
          -  History of retinal detachment, diabetic retinopathy, or active retinal disease&#xD;
&#xD;
          -  Presence of an active ocular infection or positive history of an ocular herpetic&#xD;
             infection at any visit&#xD;
&#xD;
          -  Use any of the disallowed medications during the period indicated&#xD;
&#xD;
          -  History of IOP increase as a result of steroid treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>November 15, 2017</results_first_submitted>
  <results_first_submitted_qc>March 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 30, 2018</results_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OTX-DP</title>
          <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
        </group>
        <group group_id="P2">
          <title>Placebo Vehicle</title>
          <description>PV (placebo drug delivery vehicle)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OTX-DP</title>
          <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
        </group>
        <group group_id="B2">
          <title>Placebo Vehicle</title>
          <description>PV (placebo drug delivery vehicle)</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="44"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="86"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.1" lower_limit="20" upper_limit="68"/>
                    <measurement group_id="B2" value="42.2" lower_limit="18" upper_limit="70"/>
                    <measurement group_id="B3" value="40" lower_limit="18" upper_limit="70"/>
                  </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="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Iris Color</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Blue</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Brown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hazel</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Green</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</title>
        <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
        <time_frame>3 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OTX-DP</title>
            <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle</title>
            <description>PV (placebo drug delivery vehicle)</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</title>
          <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.04" spread="1.088"/>
                    <measurement group_id="O2" value="2.31" spread="1.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6</title>
        <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
        <time_frame>5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OTX-DP</title>
            <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle</title>
            <description>PV (placebo drug delivery vehicle)</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6</title>
          <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.07" spread="1.100"/>
                    <measurement group_id="O2" value="2.41" spread="1.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</title>
        <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
        <time_frame>7 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OTX-DP</title>
            <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle</title>
            <description>PV (placebo drug delivery vehicle)</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6</title>
          <description>Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="1.131"/>
                    <measurement group_id="O2" value="2.37" spread="1.129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>OTX-DP</title>
          <description>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use</description>
        </group>
        <group group_id="E2">
          <title>Placebo Vehicle</title>
          <description>PV (placebo drug delivery vehicle)</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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse Events</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="40"/>
              </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 NOT 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>Jamie L. Metzinger, Medical Affairs</name_or_title>
      <organization>Ocular Therapeutix</organization>
      <phone>781-357-4000</phone>
      <email>jmetzinger@ocutx.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/NCT02988882
org study id: OTX-15-002
nct id: NCT02988882
lead sponsor: 
collaborator: 
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of chronic allergic conjunctivitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
time frame: 3 minutes
description: Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
measure: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
time frame: 5 minutes
description: Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
time frame: 7 minutes
description: Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
arm group label: OTX-DP
arm group type: Experimental
description: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
arm group label: PV
arm group type: Placebo Comparator
description: PV (placebo drug delivery vehicle)
intervention type: Drug
intervention name: Dexamethasone
arm group label: OTX-DP
intervention type: Other
intervention name: Placebo Vehicle
arm group label: PV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Dexamethasone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 