<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/NCT02218489</url>
  </required_header>
  <id_info>
    <org_study_id>KPI-121-C-003</org_study_id>
    <nct_id>NCT02218489</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease</brief_title>
  <acronym>Maui</acronym>
  <official_title>A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kala Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kala Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine the efficacy and safety of KPI-121&#xD;
      ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of&#xD;
      inflammatory meibomian gland disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled,&#xD;
      parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic&#xD;
      suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland&#xD;
      disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four&#xD;
      times daily (QID).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Change From Baseline in Ocular Discomfort</measure>
    <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
    <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</measure>
    <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
    <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ocular Discomfort</measure>
    <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
    <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</measure>
    <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
    <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Posterior Lid Margin Hyperemia</measure>
    <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
    <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Posterior Lid Margin Hyperemia</measure>
    <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
    <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Blepharitis</condition>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KPI-121 0.25% Ophthalmic Suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KPI-121</intervention_name>
    <description>KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.</description>
    <arm_group_label>KPI-121 0.25% Ophthalmic Suspension</arm_group_label>
    <other_name>KPI-121 0.25% Ophthalmic Suspension</other_name>
    <other_name>Loteprednol etabonate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>KPI-121 0.25% Vehicle</other_name>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity/contraindication to study product(s) or components.&#xD;
&#xD;
          -  Be currently receiving treatment for glaucoma, have history of or current glaucoma, or&#xD;
             an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2&#xD;
             (Randomization).&#xD;
&#xD;
          -  Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14&#xD;
             days prior to Day 1 and for the duration of the study.&#xD;
&#xD;
          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in&#xD;
             judgment of Investigator could confound study assessments or limit compliance;&#xD;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of&#xD;
             Investigator could confound study assessments or limit compliance; or have been&#xD;
             exposed to an investigational drug within the 30 days prior to screening.&#xD;
&#xD;
          -  Have had ocular surgery in the past 90 days or require ocular surgery during the&#xD;
             study.&#xD;
&#xD;
          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply&#xD;
             with study protocol or unable to successfully instill eye drops.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Abrams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abrams Eye Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Damien Goldberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolstan &amp; Goldberg Eye Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jodi Luchs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>South Shore Eye Center, LLP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kelly Nichols, OD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UAB School of Optometry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Rauchman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Valley Eye Medical Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Sall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sall Research Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Sheppard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Eye Consultants</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joseph Tauber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tauber Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB School of Optometry</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-0010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sall Research Medical Center</name>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <zip>90701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Valley Eye Medical Group</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tauber Eye Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Eye Center, LLP</name>
      <address>
        <city>Wantagh</city>
        <state>New York</state>
        <zip>11793</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abrams Eye Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Eye Consultants</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>November 25, 2020</results_first_submitted>
  <results_first_submitted_qc>January 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2021</results_first_posted>
  <disposition_first_submitted>October 19, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>October 19, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 20, 2016</disposition_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Corticosteroid</keyword>
  <keyword>Meibomian Gland Disease</keyword>
  <keyword>Blepharitis</keyword>
  <keyword>Eyelid</keyword>
  <keyword>Ocular Discomfort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharitis</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 3, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT02218489/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>206 subjects were randomized, 1 of which were not included in any analysis population as the individual did not receive randomized treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Vehicle</title>
          <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
        </group>
        <group group_id="P2">
          <title>KPI-121 0.25% Ophthalmic Suspension</title>
          <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vehicle</title>
          <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
        </group>
        <group group_id="B2">
          <title>KPI-121 0.25% Ophthalmic Suspension</title>
          <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.</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="101"/>
            <count group_id="B2" value="104"/>
            <count group_id="B3" value="205"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" spread="13.13"/>
                    <measurement group_id="B2" value="60.2" spread="11.28"/>
                    <measurement group_id="B3" value="59.4" spread="12.22"/>
                  </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="72"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="71"/>
                  </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="28"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="142"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Ocular Discomfort</title>
        <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15).</description>
        <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ocular Discomfort</title>
          <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15).</description>
          <population>ITT population</population>
          <units>score 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="101"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="13.8"/>
                    <measurement group_id="O2" value="-2.4" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</title>
        <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
        <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
        <population>m1ITT- a subset of the ITT population with greater baseline hyperemia</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</title>
          <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
          <population>m1ITT- a subset of the ITT population with greater baseline hyperemia</population>
          <units>score 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="77"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.7"/>
                    <measurement group_id="O2" value="-04" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ocular Discomfort</title>
        <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29).</description>
        <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ocular Discomfort</title>
          <description>Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29).</description>
          <population>ITT population</population>
          <units>score 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="101"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="17.1"/>
                    <measurement group_id="O2" value="-5.0" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</title>
        <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
        <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
        <population>m1ITT- a subset of the ITT population with greater baseline hyperemia. m1ITT population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline</title>
          <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
          <population>m1ITT- a subset of the ITT population with greater baseline hyperemia. m1ITT population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.</population>
          <units>score 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="76"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.7"/>
                    <measurement group_id="O2" value="-0.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Posterior Lid Margin Hyperemia</title>
        <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
        <time_frame>Visit 2 (Day 1) to Visit 4 (Day 15)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Posterior Lid Margin Hyperemia</title>
          <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
          <population>ITT population</population>
          <units>score 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="101"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.72"/>
                    <measurement group_id="O2" value="-0.55" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Posterior Lid Margin Hyperemia</title>
        <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
        <time_frame>Visit 2 (Day 1) to Visit 6 (Day 29)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
          </group>
          <group group_id="O2">
            <title>KPI-121 0.25% Ophthalmic Suspension</title>
            <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Posterior Lid Margin Hyperemia</title>
          <description>Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:&#xD;
0=normal&#xD;
mild&#xD;
moderate&#xD;
severe&#xD;
very severe</description>
          <population>ITT population</population>
          <units>score 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="101"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.63" spread="0.76"/>
                    <measurement group_id="O2" value="-0.65" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time a subject signed the informed consent at Visit 1 until they exited the study at Visit 6.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vehicle</title>
          <description>Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
Vehicle: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.</description>
        </group>
        <group group_id="E2">
          <title>KPI-121 0.25% Ophthalmic Suspension</title>
          <description>KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease&#xD;
KPI-121: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.</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="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="104"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="104"/>
              </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 agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following:&#xD;
(a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>VP, Clinical Development</name_or_title>
      <organization>Kala Pharmaceuticals, Inc</organization>
      <phone>781-996-5252</phone>
      <email>Results003@kalarx.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/NCT02218489
org study id: KPI-121-C-003
nct id: NCT02218489
lead sponsor: 
has dmc: No
The primary purpose of this study is to determine the efficacy and safety of KPI-121
      ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of
      inflammatory meibomian gland disease.
This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled,
      parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic
      suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland
      disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four
      times daily (QID).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Ocular Discomfort
time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
description: Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15).
measure: Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
description: Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
measure: Change From Baseline in Ocular Discomfort
time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
description: Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29).
measure: Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
description: Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
measure: Change From Baseline in Posterior Lid Margin Hyperemia
time frame: Visit 2 (Day 1) to Visit 4 (Day 15)
description: Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
measure: Change From Baseline in Posterior Lid Margin Hyperemia
time frame: Visit 2 (Day 1) to Visit 6 (Day 29)
description: Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:
0=normal
mild
moderate
severe
very severe
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
arm group label: KPI-121 0.25% Ophthalmic Suspension
arm group type: Active Comparator
description: KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
intervention type: Drug
intervention name: KPI-121
description: KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
arm group label: KPI-121 0.25% Ophthalmic Suspension
other name: KPI-121 0.25% Ophthalmic Suspension
other name: Loteprednol etabonate
intervention type: Drug
intervention name: Vehicle
description: The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
arm group label: Vehicle
other name: KPI-121 0.25% Vehicle
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Abrams, MD
role: Principal Investigator
affiliation: Abrams Eye Center
last name: Damien Goldberg, MD
role: Principal Investigator
affiliation: Wolstan & Goldberg Eye Associates
last name: Jodi Luchs, MD
role: Principal Investigator
affiliation: South Shore Eye Center, LLP
last name: Kelly Nichols, OD, PhD
role: Principal Investigator
affiliation: UAB School of Optometry
last name: Steven Rauchman, MD
role: Principal Investigator
affiliation: North Valley Eye Medical Group
last name: Kenneth Sall, MD
role: Principal Investigator
affiliation: Sall Research Medical Center
last name: John Sheppard, MD
role: Principal Investigator
affiliation: Virginia Eye Consultants
last name: Joseph Tauber, MD
role: Principal Investigator
affiliation: Tauber Eye Center
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country: United States
responsible party type: Sponsor
mesh term: Blepharitis
mesh term: Meibomian Gland Dysfunction
mesh term: Loteprednol Etabonate
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