<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/NCT03764735</url>
  </required_header>
  <id_info>
    <org_study_id>18-110-0004</org_study_id>
    <nct_id>NCT03764735</nct_id>
  </id_info>
  <brief_title>Study of SkQ1 as Treatment for Dry-eye Syndrome</brief_title>
  <acronym>VISTA-1</acronym>
  <official_title>A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitotech, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mitotech, SA</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and&#xD;
      effective compared to placebo for the treatment of the signs and symptoms of dry eye&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over&#xD;
      the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive&#xD;
      either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo&#xD;
      (vehicle of SkQ1 ophthalmic solution).&#xD;
&#xD;
      The Primary Endpoints are:&#xD;
&#xD;
      Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;&#xD;
&#xD;
      Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">February 9, 2019</completion_date>
  <primary_completion_date type="Actual">February 9, 2019</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>
    <intervention_model_description>Parallel-group study of two strengths of ophthalmic solution versus placebo solution</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central Corneal Staining Change From Baseline</measure>
    <time_frame>From baseline to Day 57</time_frame>
    <description>Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grittiness Change From Baseline</measure>
    <time_frame>From baseline to Day 57</time_frame>
    <description>Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">452</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>SkQ1 Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SkQ1 (Vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose - SkQ1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-dose ophthalmic solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose - SkQ1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-dose ophthalmic solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose - SkQ1</intervention_name>
    <description>SkQ1 Low dose ophthalmic solution</description>
    <arm_group_label>Low Dose - SkQ1</arm_group_label>
    <other_name>Visomitin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose - SkQ1</intervention_name>
    <description>SkQ1 High Dose ophthalmic solution</description>
    <arm_group_label>High Dose - SkQ1</arm_group_label>
    <other_name>Visomitin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SkQ1 (Vehicle)</intervention_name>
    <description>Vehicle for SkQ1 ophthalmic solution</description>
    <arm_group_label>SkQ1 Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age;&#xD;
&#xD;
          -  Provide written informed consent;&#xD;
&#xD;
          -  Have a subject reported history of dry eye;&#xD;
&#xD;
          -  Have a history of use of eye drops for dry eye symptoms ;&#xD;
&#xD;
          -  Ocular Discomfort;&#xD;
&#xD;
          -  Schirmer's Test score;&#xD;
&#xD;
          -  Have corneal fluorescein staining ;&#xD;
&#xD;
          -  Have lissamine green conjunctival Staining ;&#xD;
&#xD;
          -  Have a conjunctival redness;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;&#xD;
&#xD;
          -  Have any clinically significant slit lamp findings at Visit 1;&#xD;
&#xD;
          -  Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit&#xD;
             1;&#xD;
&#xD;
          -  Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned&#xD;
             over the study period;&#xD;
&#xD;
          -  Have an uncontrolled systemic disease;&#xD;
&#xD;
          -  Be a woman who is pregnant, nursing or planning a pregnancy;&#xD;
&#xD;
          -  Be a woman of childbearing potential who is not using an acceptable means of birth&#xD;
             control;&#xD;
&#xD;
          -  Have a known allergy and/or sensitivity to the study drug or its components ;&#xD;
&#xD;
          -  Have a condition or be in a situation which the investigator feels may put the subject&#xD;
             at significant risk, may confound the study results, or may interfere significantly&#xD;
             with the subject's participation in the study;&#xD;
&#xD;
          -  Be currently enrolled in an investigational drug or device study or have used an&#xD;
             investigational drug or device within 30 days of Visit 1;&#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>Lawrence T Friedhoff, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Mitotech, SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cornea &amp; Cataract Consultants of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Insititute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Maine Eye Care</name>
      <address>
        <city>Lewiston</city>
        <state>Maine</state>
        <zip>04240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Vita Eye Clinic</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care, PA</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>December 20, 2021</results_first_submitted>
  <results_first_submitted_qc>December 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2022</results_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye</keyword>
  <keyword>Dry Eye Syndrome</keyword>
  <keyword>SkQ1</keyword>
  <keyword>KCS</keyword>
  <keyword>Keratoconjunctivitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benzalkonium Compounds</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03764735/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SkQ1 Vehicle</title>
          <description>Vehicle for SkQ1 ophthalmic solution</description>
        </group>
        <group group_id="P2">
          <title>Low Dose - SkQ1</title>
          <description>SkQ1 Low dose ophthalmic solution</description>
        </group>
        <group group_id="P3">
          <title>High Dose - SkQ1</title>
          <description>SkQ1 High Dose ophthalmic solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="144"/>
                <participants group_id="P3" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SkQ1 Vehicle</title>
          <description>Vehicle for SkQ1 ophthalmic solution</description>
        </group>
        <group group_id="B2">
          <title>Low Dose - SkQ1</title>
          <description>SkQ1 Low dose ophthalmic solution</description>
        </group>
        <group group_id="B3">
          <title>High Dose - SkQ1</title>
          <description>SkQ1 High Dose ophthalmic solution</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="151"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="151"/>
            <count group_id="B4" value="451"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="64.4" spread="12.98"/>
                    <measurement group_id="B2" value="64.4" spread="12.35"/>
                    <measurement group_id="B3" value="61.4" spread="13.58"/>
                    <measurement group_id="B4" value="63.4" spread="13.03"/>
                  </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="115"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="424"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="120"/>
                    <measurement group_id="B4" value="374"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="151"/>
                    <measurement group_id="B4" value="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Central CFS</title>
          <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="1.72" spread="0.73"/>
                    <measurement group_id="B2" value="1.67" spread="0.69"/>
                    <measurement group_id="B3" value="1.67" spread="0.68"/>
                    <measurement group_id="B4" value="1.69" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Central Corneal Staining Change From Baseline</title>
        <description>Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe</description>
        <time_frame>From baseline to Day 57</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SkQ1 Vehicle</title>
            <description>Vehicle for SkQ1 ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>Low Dose - SkQ1</title>
            <description>SkQ1 Low dose ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>High Dose - SkQ1</title>
            <description>SkQ1 High Dose ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Central Corneal Staining Change From Baseline</title>
          <description>Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe</description>
          <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="151"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="0.773"/>
                    <measurement group_id="O2" value="-0.3" spread="0.816"/>
                    <measurement group_id="O3" value="-0.2" spread="0.763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Grittiness Change From Baseline</title>
        <description>Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst</description>
        <time_frame>From baseline to Day 57</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SkQ1 Vehicle</title>
            <description>Vehicle for SkQ1 ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>Low Dose - SkQ1</title>
            <description>SkQ1 Low dose ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>High Dose - SkQ1</title>
            <description>SkQ1 High Dose ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Grittiness Change From Baseline</title>
          <description>Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst</description>
          <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="151"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="1.108"/>
                    <measurement group_id="O2" value="-0.36" spread="1.176"/>
                    <measurement group_id="O3" value="-0.43" spread="1.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day -7 through end of study (Day 57)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SkQ1 Vehicle</title>
          <description>Vehicle for SkQ1 ophthalmic solution</description>
        </group>
        <group group_id="E2">
          <title>Low Dose - SkQ1</title>
          <description>SkQ1 Low dose ophthalmic solution</description>
        </group>
        <group group_id="E3">
          <title>High Dose - SkQ1</title>
          <description>SkQ1 High Dose ophthalmic solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="3" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="151"/>
              </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>Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Operating Officer</name_or_title>
      <organization>Mitotech S.A.</organization>
      <phone>+352621692785</phone>
      <email>info@mitotechpharma.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/NCT03764735
org study id: 18-110-0004
nct id: NCT03764735
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and
      effective compared to placebo for the treatment of the signs and symptoms of dry eye
      syndrome.
Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over
      the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive
      either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo
      (vehicle of SkQ1 ophthalmic solution).

      The Primary Endpoints are:

      Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

      Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Central Corneal Staining Change From Baseline
time frame: From baseline to Day 57
description: Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
measure: Grittiness Change From Baseline
time frame: From baseline to Day 57
description: Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst
arm group label: SkQ1 Vehicle
arm group type: Placebo Comparator
description: SkQ1 (Vehicle)
arm group label: Low Dose - SkQ1
arm group type: Active Comparator
description: Low-dose ophthalmic solution
arm group label: High Dose - SkQ1
arm group type: Active Comparator
description: High-dose ophthalmic solution
intervention type: Drug
intervention name: Low Dose - SkQ1
description: SkQ1 Low dose ophthalmic solution
arm group label: Low Dose - SkQ1
other name: Visomitin
intervention type: Drug
intervention name: High dose - SkQ1
description: SkQ1 High Dose ophthalmic solution
arm group label: High Dose - SkQ1
other name: Visomitin
intervention type: Drug
intervention name: SkQ1 (Vehicle)
description: Vehicle for SkQ1 ophthalmic solution
arm group label: SkQ1 Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence T Friedhoff, MD, PhD
role: Study Chair
affiliation: Mitotech, SA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome
mesh term: Benzalkonium Compounds
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 