<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/NCT01666210</url>
  </required_header>
  <id_info>
    <org_study_id>OTX-12-002</org_study_id>
    <nct_id>NCT01666210</nct_id>
  </id_info>
  <brief_title>Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ocular Therapeutix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ocular Therapeutix, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)&#xD;
      depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation&#xD;
      and pain in subjects who have undergone cataract extraction with intra-ocular lens&#xD;
      implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of Cells in Anterior Chamber of Study Eye</measure>
    <time_frame>Day 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of Pain in the Study Eye</measure>
    <time_frame>Day 8</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Duration of each individual subject's participation in the study, up to 60 days</time_frame>
    <description>Measure of adverse events over the duration of each subject's participation in the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Ocular Inflammation and Pain</condition>
  <arm_group>
    <arm_group_label>Dexamethasone Punctum Plug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Vehicle Punctum Plug</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo punctum plug insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTX-DP (Dexamethasone punctum plug)</intervention_name>
    <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
    <arm_group_label>Dexamethasone Punctum Plug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Vehicle Punctum Plug</intervention_name>
    <description>Hydrogel punctum plug without dexamethasone</description>
    <arm_group_label>Placebo Vehicle Punctum Plug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has provided written informed consent, approved by the appropriate institutional&#xD;
             review board; and is able to comply with study requirements and visit schedule&#xD;
&#xD;
          -  Is greater than or equal to 21 years of age&#xD;
&#xD;
          -  Has a cataract and is expected to undergo clear corneal cataract surgery with&#xD;
             phacoemulsification and implantation of a posterior chamber intraocular lens&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any intraocular inflammation in the study eye present during the screening slit lamp&#xD;
             examination&#xD;
&#xD;
          -  Score greater than &quot;0&quot; on the Ocular Pain Assessment at Screening&#xD;
&#xD;
          -  Compromised immune system or an autoimmune disease that in the opinion of the&#xD;
             Investigator could affect the quality of the ocular surface&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chicago Cornea Consultants, Ltd.</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>February 9, 2016</results_first_submitted>
  <results_first_submitted_qc>March 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2017</results_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 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>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dexamethasone Punctum Plug</title>
          <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
        </group>
        <group group_id="P2">
          <title>Placebo Vehicle Punctum Plug</title>
          <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dexamethasone Punctum Plug</title>
          <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
        </group>
        <group group_id="B2">
          <title>Placebo Vehicle Punctum Plug</title>
          <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age between 21 - 65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age greater than or equal to 65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </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="17"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absence of Cells in Anterior Chamber of Study Eye</title>
        <time_frame>Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone Punctum Plug</title>
            <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle Punctum Plug</title>
            <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Absence of Cells in Anterior Chamber of Study Eye</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absence of Pain in the Study Eye</title>
        <time_frame>Day 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone Punctum Plug</title>
            <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle Punctum Plug</title>
            <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Absence of Pain in the Study Eye</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Events</title>
        <description>Measure of adverse events over the duration of each subject's participation in the study.</description>
        <time_frame>Duration of each individual subject's participation in the study, up to 60 days</time_frame>
        <population>Ocular adverse events</population>
        <group_list>
          <group group_id="O1">
            <title>Dexamethasone Punctum Plug</title>
            <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
          </group>
          <group group_id="O2">
            <title>Placebo Vehicle Punctum Plug</title>
            <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Measure of adverse events over the duration of each subject's participation in the study.</description>
          <population>Ocular adverse events</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="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days.</time_frame>
      <desc>The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dexamethasone Punctum Plug</title>
          <description>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days&#xD;
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug</description>
        </group>
        <group group_id="E2">
          <title>Placebo Vehicle Punctum Plug</title>
          <description>Placebo punctum plug insertion&#xD;
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders</sub_title>
                <description>Visual Acuity Reduced, Conjunctival Hyperemia, Corneal Edema, Anterior Chamber Inflammation, Conjunctival Hemorrhage, Cystoid Macular Edema, Eye Discharge, Eye Disorder, Eye Pain, Iritis, Lenticular Opacities, Photophobia</description>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PIs agree that the first publication of the data and results of the Study shall be made in conjunction with the presentation of a joint, multi-center publication of the Study results, with the investigators from all appropriate sites contributing data, analyses, and comments.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Ankerud</name_or_title>
      <organization>Ocular Therapeutix, Inc.</organization>
      <phone>781-357-4013</phone>
      <email>eankerud@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/NCT01666210
org study id: OTX-12-002
nct id: NCT01666210
lead sponsor: 
has dmc: No
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)
      depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation
      and pain in subjects who have undergone cataract extraction with intra-ocular lens
      implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absence of Cells in Anterior Chamber of Study Eye
time frame: Day 8
measure: Absence of Pain in the Study Eye
time frame: Day 8
measure: Adverse Events
time frame: Duration of each individual subject's participation in the study, up to 60 days
description: Measure of adverse events over the duration of each subject's participation in the study.
arm group label: Dexamethasone Punctum Plug
arm group type: Active Comparator
description: Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
arm group label: Placebo Vehicle Punctum Plug
arm group type: Placebo Comparator
description: Placebo punctum plug insertion
intervention type: Drug
intervention name: OTX-DP (Dexamethasone punctum plug)
description: Sustained and tapered release of dexamethasone from hydrogel punctum plug
arm group label: Dexamethasone Punctum Plug
intervention type: Drug
intervention name: Placebo Vehicle Punctum Plug
description: Hydrogel punctum plug without dexamethasone
arm group label: Placebo Vehicle Punctum Plug
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Capsule Opacification
mesh term: Inflammation
mesh term: Dexamethasone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 