<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/NCT01730872</url>
  </required_header>
  <id_info>
    <org_study_id>12-270-0007</org_study_id>
    <nct_id>NCT01730872</nct_id>
  </id_info>
  <brief_title>Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model</brief_title>
  <official_title>A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ORA, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of the modified Conjunctival&#xD;
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to&#xD;
      treatment with a proven ocular anti-inflammatory medication,&#xD;
&#xD;
      Prednisolone, assessed by the following measures:&#xD;
&#xD;
      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival&#xD;
      redness&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single center, randomized, double-masked, placebo controlled study. Subjects&#xD;
      will be randomized to one of the following treatment arms to dose four times per day (QID)&#xD;
      for 4 days between Visits 3 and 4.&#xD;
&#xD;
      Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)&#xD;
&#xD;
      Duration:&#xD;
&#xD;
      Approximately 2 weeks&#xD;
&#xD;
      Controls:&#xD;
&#xD;
      Artificial Tears (Tears Naturale® II)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammation Change From Baseline to Day 6</measure>
    <time_frame>90 minutes post CAC</time_frame>
    <description>Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Itching Change From Baseline to Day 6</measure>
    <time_frame>7 minutes post-CAC</time_frame>
    <description>Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Redness Change From Baseline to Day 6</measure>
    <time_frame>7 minutes post-CAC</time_frame>
    <description>Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Chronic Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Prednisolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tears Naturale II Ophthalmic Solution, 1%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone Sodium Phosphate Ophthalmic Solution 1%</intervention_name>
    <description>One drop in each eye, four times/day for 4 days.</description>
    <arm_group_label>Prednisolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tears Naturale II Ophthalmic Solution</intervention_name>
    <description>one drop in each eye, four times/ day (QID) for 4 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age &amp; either sex, any race&#xD;
&#xD;
          -  Willing and able to follow all instructions&#xD;
&#xD;
          -  Positive history of ocular allergies&#xD;
&#xD;
          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen&#xD;
             challenge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have planned surgery during trial period&#xD;
&#xD;
          -  Female currently pregnant, planning a pregnancy or lactating&#xD;
&#xD;
          -  Use of disallowed medications&#xD;
&#xD;
          -  Have ocular infections, or ocular conditions that could affect study parameters&#xD;
&#xD;
          -  Have moderate to severe dry eye&#xD;
&#xD;
          -  Have used an investigational drug or device within 30 days of start of study&#xD;
&#xD;
          -  Female that is currently pregnant, planning a pregnancy or lactating&#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>Gail Torkildsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>December 27, 2018</results_first_submitted>
  <results_first_submitted_qc>June 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prednisolone</title>
          <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
        </group>
        <group group_id="P3">
          <title>Control</title>
          <description>Subjects received CAC using saline instead of allergen</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4">1 subject did not complete the last post-CAE measurement on Day 6 and was excluded from the FAS</participants>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prednisolone</title>
          <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
        </group>
        <group group_id="B3">
          <title>Saline</title>
          <description>A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="16"/>
          </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="41.75" spread="1.461897"/>
                    <measurement group_id="B2" value="37.2" spread="1.830301"/>
                    <measurement group_id="B3" value="39.33" spread="0.905539"/>
                    <measurement group_id="B4" value="39.88" spread="0.0707107"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Inflammation Change From Baseline to Day 6</title>
        <description>Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).</description>
        <time_frame>90 minutes post CAC</time_frame>
        <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisolone</title>
            <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammation Change From Baseline to Day 6</title>
          <description>Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).</description>
          <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</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="8"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.78"/>
                    <measurement group_id="O2" value="-0.19" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Itching Change From Baseline to Day 6</title>
        <description>Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC</description>
        <time_frame>7 minutes post-CAC</time_frame>
        <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisolone</title>
            <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Itching Change From Baseline to Day 6</title>
          <description>Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC</description>
          <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</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="8"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="1.30"/>
                    <measurement group_id="O2" value="-1.0" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Redness Change From Baseline to Day 6</title>
        <description>Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).</description>
        <time_frame>7 minutes post-CAC</time_frame>
        <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisolone</title>
            <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Redness Change From Baseline to Day 6</title>
          <description>Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).</description>
          <population>The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.</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="8"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="1.38"/>
                    <measurement group_id="O2" value="0.31" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prednisolone</title>
          <description>Prednisolone Sodium Phosphate Ophthalmic Solution, 1%&#xD;
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Tears Naturale II Ophthalmic Solution, 1%&#xD;
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days</description>
        </group>
        <group group_id="E3">
          <title>Saline</title>
          <description>A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>peri-ocular lid redness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>endothelial pigment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>lower leg pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Keith Lane</name_or_title>
      <organization>Ora</organization>
      <phone>9786858900</phone>
      <email>klane@oraclinical.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/NCT01730872
org study id: 12-270-0007
nct id: NCT01730872
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to
      treatment with a proven ocular anti-inflammatory medication,

      Prednisolone, assessed by the following measures:

      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival
      redness
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects
      will be randomized to one of the following treatment arms to dose four times per day (QID)
      for 4 days between Visits 3 and 4.

      Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

      Duration:

      Approximately 2 weeks

      Controls:

      Artificial Tears (Tears Naturale® II)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Inflammation Change From Baseline to Day 6
time frame: 90 minutes post CAC
description: Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
measure: Ocular Itching Change From Baseline to Day 6
time frame: 7 minutes post-CAC
description: Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
measure: Ocular Redness Change From Baseline to Day 6
time frame: 7 minutes post-CAC
description: Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
arm group label: Prednisolone
arm group type: Experimental
description: Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
arm group label: Placebo
arm group type: Placebo Comparator
description: Tears Naturale II Ophthalmic Solution, 1%
intervention type: Drug
intervention name: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
description: One drop in each eye, four times/day for 4 days.
arm group label: Prednisolone
intervention type: Drug
intervention name: Tears Naturale II Ophthalmic Solution
description: one drop in each eye, four times/ day (QID) for 4 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gail Torkildsen, MD
role: Principal Investigator
affiliation: Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 