<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/NCT02208297</url>
  </required_header>
  <id_info>
    <org_study_id>843</org_study_id>
    <nct_id>NCT02208297</nct_id>
  </id_info>
  <brief_title>Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery</brief_title>
  <official_title>Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch &amp; Lomb Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch &amp; Lomb Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate&#xD;
      (LE) ophthalmic gel, 0.38% (BID)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate&#xD;
      (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following&#xD;
      cataract surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells</measure>
    <time_frame>8 days</time_frame>
    <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Grade 0 Pain in the Study Eye.</measure>
    <time_frame>8 days</time_frame>
    <description>Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit</measure>
    <time_frame>18 days</time_frame>
    <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.</measure>
    <time_frame>18 days</time_frame>
    <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.</measure>
    <time_frame>18 days</time_frame>
    <description>Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.</measure>
    <time_frame>18 days</time_frame>
    <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Inflammation</condition>
  <condition>Pain</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Loteprednol Etabonate Gel (BID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Gel (BID)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle gel administered two times daily (BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loteprednol Etabonate Gel (BID)</intervention_name>
    <description>One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
    <arm_group_label>Loteprednol Etabonate Gel (BID)</arm_group_label>
    <other_name>Lotemax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Gel (BID)</intervention_name>
    <description>One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
    <arm_group_label>Vehicle Gel (BID)</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Visit 1 (Screening Visit)&#xD;
&#xD;
          -  Be willing and able to comply with all treatment and follow-up/study procedures.&#xD;
&#xD;
          -  Be a candidate for routine, uncomplicated cataract surgery.&#xD;
&#xD;
        Visit 3 (Postoperative Day 1)&#xD;
&#xD;
          -  Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with&#xD;
             posterior chamber intraocular lens (IOL) implantation, not combined with any other&#xD;
             surgery) in the study eye.&#xD;
&#xD;
          -  Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a severe/serious ocular condition or history/presence of chronic generalized&#xD;
             systemic disease that the Investigator feels might increase the risk to the subject or&#xD;
             confound the result(s) of the study.&#xD;
&#xD;
          -  Have known hypersensitivity or contraindication to the study drug(s) or their&#xD;
             components.&#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>Jason Vittitow</last_name>
    <role>Study Director</role>
    <affiliation>Valeant/Bausch &amp; Lomb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bausch &amp; Lomb Incorporated</name>
      <address>
        <city>Bridgewater</city>
        <state>New Jersey</state>
        <zip>08807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>August 18, 2020</results_first_submitted>
  <results_first_submitted_qc>August 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 3, 2020</results_first_posted>
  <disposition_first_submitted>December 8, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 8, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 11, 2018</disposition_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 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>Cataract</mesh_term>
    <mesh_term>Inflammation</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Loteprednol Etabonate Gel (BID)</title>
          <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
        <group group_id="P2">
          <title>Vehicle Gel (BID)</title>
          <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Loteprednol Etabonate Gel (BID)</title>
          <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
        <group group_id="B2">
          <title>Vehicle Gel (BID)</title>
          <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="163"/>
            <count group_id="B2" value="163"/>
            <count group_id="B3" value="326"/>
          </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="67.0" spread="9.88"/>
                    <measurement group_id="B2" value="67.8" spread="8.45"/>
                    <measurement group_id="B3" value="67.4" spread="9.19"/>
                  </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="89"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells</title>
        <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
        <time_frame>8 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells</title>
          <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Grade 0 Pain in the Study Eye.</title>
        <description>Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.</description>
        <time_frame>8 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Grade 0 Pain in the Study Eye.</title>
          <description>Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit</title>
        <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
        <time_frame>18 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit</title>
          <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.</title>
        <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
        <time_frame>18 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.</title>
          <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.</title>
        <description>Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.</description>
        <time_frame>18 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.</title>
          <description>Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.</title>
        <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).</description>
        <time_frame>18 days</time_frame>
        <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Loteprednol Etabonate Gel (BID)</title>
            <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel (BID)</title>
            <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.</title>
          <description>White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = &gt; 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).</description>
          <population>The analysis population included all randomized participants, with missing values imputed as non-responders.</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="163"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 days</time_frame>
      <desc>The safety analysis population included all randomized participants who received treatment. There was one participant who did not receive treatment, thus there were 325 participants in the safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Loteprednol Etabonate Gel (BID)</title>
          <description>Loteprednol Etabonate Gel 0.38% administered two times daily (BID)&#xD;
Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
        <group group_id="E2">
          <title>Vehicle Gel (BID)</title>
          <description>Vehicle gel administered two times daily (BID)&#xD;
Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="162"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="163"/>
              </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="0" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="163"/>
              </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>Contact sponsor directly for details.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Bausch Health</organization>
      <email>susan.harris@bauschhealth.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/NCT02208297
org study id: 843
nct id: NCT02208297
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      (LE) ophthalmic gel, 0.38% (BID)
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following
      cataract surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
time frame: 8 days
description: White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
measure: Percentage of Participants With Grade 0 Pain in the Study Eye.
time frame: 8 days
description: Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
time frame: 18 days
description: White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
measure: Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
time frame: 18 days
description: White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
time frame: 18 days
description: Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
time frame: 18 days
description: White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).
arm group label: Loteprednol Etabonate Gel (BID)
arm group type: Experimental
description: Loteprednol Etabonate Gel 0.38% administered two times daily (BID)
arm group label: Vehicle Gel (BID)
arm group type: Placebo Comparator
description: Vehicle gel administered two times daily (BID)
intervention type: Drug
intervention name: Loteprednol Etabonate Gel (BID)
description: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
arm group label: Loteprednol Etabonate Gel (BID)
other name: Lotemax
intervention type: Drug
intervention name: Vehicle Gel (BID)
description: One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days
arm group label: Vehicle Gel (BID)
other name: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Vittitow
role: Study Director
affiliation: Valeant/Bausch & Lomb
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Inflammation
mesh term: Loteprednol Etabonate
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 