<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/NCT04469998</url>
  </required_header>
  <id_info>
    <org_study_id>AXR201901</org_study_id>
    <nct_id>NCT04469998</nct_id>
  </id_info>
  <brief_title>Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction</brief_title>
  <official_title>A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AxeroVision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AxeroVision, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating&#xD;
      posterior blepharitis associated with Meibomian Gland Disease (MGD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270&#xD;
      cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis&#xD;
      associated with meibomian gland dysfunction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Adverse Events</measure>
    <time_frame>22 Days</time_frame>
    <description>Incidence of treatment emergent ocular and systemic adverse events (TEAE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Meibomian Gland Dysfunction Score</measure>
    <time_frame>22 Days</time_frame>
    <description>Change from Baseline in total MGD score (Study Eyelid):&#xD;
The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome.&#xD;
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Posterior Blepharitis</condition>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>AXR-270 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AXR-270 Low Dose administered once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AXR-270 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AXR-270 High Dose administered once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AXR-270 Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>AXR-270 Vehicle administered once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AXR-270 Low Dose</intervention_name>
    <description>AXR-270 Topical Eyelid Cream</description>
    <arm_group_label>AXR-270 Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AXR-270 High Dose</intervention_name>
    <description>AXR-270 Topical Eyelid Cream</description>
    <arm_group_label>AXR-270 High Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AXR-270 Vehicle</intervention_name>
    <description>AXR-270 Topical Eyelid Cream Vehicle</description>
    <arm_group_label>AXR-270 Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female, 18 years or older&#xD;
&#xD;
        Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a&#xD;
        scale with a range between 0 and 15; and clinical severity score of eyelid margin&#xD;
        vascularity of at least 2 (moderate))&#xD;
&#xD;
        Have a score of ≥35 on Eye Discomfort using VAS&#xD;
&#xD;
        Have a tFCS score between 3 and 14 on the NEI scale&#xD;
&#xD;
        Have a Schirmer score of &gt;7 mm&#xD;
&#xD;
        Have a OSDI score &gt;30&#xD;
&#xD;
        If female, then subject should be non-pregnant and non-lactating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with iritis, uveitis in either eye&#xD;
&#xD;
        Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD&#xD;
&#xD;
        Subjects with lid abnormalities&#xD;
&#xD;
        Subjects with ocular fungal, viral or bacterial infection&#xD;
&#xD;
        Subjects unable or unwilling to withhold the use of eyelid scrubs&#xD;
&#xD;
        Subjects with glaucoma and serious systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Houman D Hemmati, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AxeroVision, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AxeroVision, Inc.</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <results_first_submitted>January 4, 2023</results_first_submitted>
  <results_first_submitted_qc>July 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2023</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meibomian Gland Dysfunction</keyword>
  <keyword>Posterior Blepharitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
    <mesh_term>Blepharitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04469998/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04469998/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AXR-270 Low Dose</title>
          <description>AXR-270 Low Dose administered once daily&#xD;
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream 0.2%</description>
        </group>
        <group group_id="P2">
          <title>AXR-270 High Dose</title>
          <description>AXR-270 High Dose administered once daily&#xD;
AXR-270 High Dose: AXR-270 Topical Eyelid Cream 2%</description>
        </group>
        <group group_id="P3">
          <title>AXR-270 Vehicle</title>
          <description>AXR-270 Vehicle administered once daily&#xD;
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Full Analysis Set (ITT Population)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43">One subject was randomized to AXR-270 Low Dose but received Vehicle instead</participants>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="42">One subject was randomized to AXR-270 Low Dose but received Vehicle instead</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Safety Set (as Treated)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42">One subject was randomized to AXR-270 Low Dose but received Vehicle instead</participants>
                <participants group_id="P2" count="43">One subject withdrew consent and was withdrawn from the study prior to dosing with the assigned treatment because the subject was not able to comply with the visit schedule</participants>
                <participants group_id="P3" count="43">One subject was randomized to AXR-270 Low Dose but received Vehicle instead</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set</population>
      <group_list>
        <group group_id="B1">
          <title>AXR-270 Low Dose</title>
          <description>AXR-270 Low Dose administered once daily&#xD;
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream</description>
        </group>
        <group group_id="B2">
          <title>AXR-270 High Dose</title>
          <description>AXR-270 High Dose administered once daily&#xD;
AXR-270 High Dose: AXR-270 Topical Eyelid Cream</description>
        </group>
        <group group_id="B3">
          <title>AXR-270 Vehicle</title>
          <description>AXR-270 Vehicle administered once daily&#xD;
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle</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="43"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="42"/>
            <count group_id="B4" value="129"/>
          </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="68.0" spread="8.7"/>
                    <measurement group_id="B2" value="63.9" spread="17.4"/>
                    <measurement group_id="B3" value="64.3" spread="15.4"/>
                    <measurement group_id="B4" value="65.4" spread="14.3"/>
                  </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="34"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <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>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <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_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="43"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Meibomian Gland Dysfunction Score</title>
          <description>The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Lower scores indicate a better outcome.&#xD;
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.7" spread="1.6"/>
                    <measurement group_id="B2" value="9.5" spread="2.3"/>
                    <measurement group_id="B3" value="10.0" spread="2.3"/>
                    <measurement group_id="B4" value="9.7" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>Incidence of treatment emergent ocular and systemic adverse events (TEAE)</description>
        <time_frame>22 Days</time_frame>
        <population>Safety Set</population>
        <group_list>
          <group group_id="O1">
            <title>AXR-270 Low Dose</title>
            <description>AXR-270 Low Dose administered once daily&#xD;
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream</description>
          </group>
          <group group_id="O2">
            <title>AXR-270 High Dose</title>
            <description>AXR-270 High Dose administered once daily&#xD;
AXR-270 High Dose: AXR-270 Topical Eyelid Cream</description>
          </group>
          <group group_id="O3">
            <title>AXR-270 Vehicle</title>
            <description>AXR-270 Vehicle administered once daily&#xD;
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Incidence of treatment emergent ocular and systemic adverse events (TEAE)</description>
          <population>Safety Set</population>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-ocular TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-ocular Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Meibomian Gland Dysfunction Score</title>
        <description>Change from Baseline in total MGD score (Study Eyelid):&#xD;
The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome.&#xD;
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.</description>
        <time_frame>22 Days</time_frame>
        <population>Full Analysis Set (Intent-to-Treat)</population>
        <group_list>
          <group group_id="O1">
            <title>AXR-270 Low Dose</title>
            <description>AXR-270 Low Dose administered once daily&#xD;
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream</description>
          </group>
          <group group_id="O2">
            <title>AXR-270 High Dose</title>
            <description>AXR-270 High Dose administered once daily&#xD;
AXR-270 High Dose: AXR-270 Topical Eyelid Cream</description>
          </group>
          <group group_id="O3">
            <title>AXR-270 Vehicle</title>
            <description>AXR-270 Vehicle administered once daily&#xD;
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle</description>
          </group>
        </group_list>
        <measure>
          <title>Total Meibomian Gland Dysfunction Score</title>
          <description>Change from Baseline in total MGD score (Study Eyelid):&#xD;
The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome.&#xD;
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.</description>
          <population>Full Analysis Set (Intent-to-Treat)</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="42"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.3"/>
                    <measurement group_id="O2" value="-1.7" spread="2.1"/>
                    <measurement group_id="O3" value="-2.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>22 days</time_frame>
      <desc>Treatment emergent ocular and non-ocular adverse events are based on the Safety Set</desc>
      <group_list>
        <group group_id="E1">
          <title>AXR-270 Low Dose</title>
          <description>AXR-270 Low Dose administered once daily&#xD;
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream</description>
        </group>
        <group group_id="E2">
          <title>AXR-270 High Dose</title>
          <description>AXR-270 High Dose administered once daily&#xD;
AXR-270 High Dose: AXR-270 Topical Eyelid Cream</description>
        </group>
        <group group_id="E3">
          <title>AXR-270 Vehicle</title>
          <description>AXR-270 Vehicle administered once daily&#xD;
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>increased blood creatine phosphokinase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>mild eyelid pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>mild eyelid erythema, edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>mild headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>mild urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </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>Clinical Study Agreement defined what qualifies as Confidential Information and restrictions on publication of study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Houman Hemmati</name_or_title>
      <organization>AxeroVision, Inc.</organization>
      <phone>+1 (310) 600-4123</phone>
      <email>houman@axerovision.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/NCT04469998
org study id: AXR201901
nct id: NCT04469998
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating
      posterior blepharitis associated with Meibomian Gland Disease (MGD)
AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270
      cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis
      associated with meibomian gland dysfunction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events
time frame: 22 Days
description: Incidence of treatment emergent ocular and systemic adverse events (TEAE)
measure: Total Meibomian Gland Dysfunction Score
time frame: 22 Days
description: Change from Baseline in total MGD score (Study Eyelid):
The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome.
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.
arm group label: AXR-270 Low Dose
arm group type: Experimental
description: AXR-270 Low Dose administered once daily
arm group label: AXR-270 High Dose
arm group type: Experimental
description: AXR-270 High Dose administered once daily
arm group label: AXR-270 Vehicle
arm group type: Placebo Comparator
description: AXR-270 Vehicle administered once daily
intervention type: Drug
intervention name: AXR-270 Low Dose
description: AXR-270 Topical Eyelid Cream
arm group label: AXR-270 Low Dose
intervention type: Drug
intervention name: AXR-270 High Dose
description: AXR-270 Topical Eyelid Cream
arm group label: AXR-270 High Dose
intervention type: Drug
intervention name: AXR-270 Vehicle
description: AXR-270 Topical Eyelid Cream Vehicle
arm group label: AXR-270 Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Houman D Hemmati, MD, PhD
role: Study Director
affiliation: AxeroVision, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Meibomian Gland Dysfunction
mesh term: Blepharitis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 