<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/NCT02974907</url>
  </required_header>
  <id_info>
    <org_study_id>RGN-259/16-110-0008</org_study_id>
    <nct_id>NCT02974907</nct_id>
  </id_info>
  <brief_title>Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2</brief_title>
  <official_title>A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye : ARISE-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ReGenTree, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ReGenTree, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic&#xD;
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry eye can be caused by many variable factors. Some examples include hormonal changes due to&#xD;
      aging, or living in an environment of low humidity for long periods of time. Dry eye is a&#xD;
      complex disease that may result in symptoms like discomfort, visual disturbance, and dryness.&#xD;
      Patients with dry eye often have damage on the surface of the eye. In previous studies,&#xD;
      RGN-259 has been shown to promote healing of the surface of the eye and decrease&#xD;
      inflammation. It suggests that RGN-259 has a significant potential to be an important new&#xD;
      safe and effective therapeutic in the treatment of dry eye syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Discomfort</measure>
    <time_frame>29 days after first dosing</time_frame>
    <description>Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corneal Fluorescein Staining</measure>
    <time_frame>29 days after first dosing</time_frame>
    <description>Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corneal Fluorescein Staining</measure>
    <time_frame>8, 15, 29 days after first dosing</time_frame>
    <description>Comparing each of active group &amp; Placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanesthetized Schirmer's Test</measure>
    <time_frame>29 days after first dosing</time_frame>
    <description>Comparing each of active group &amp; Placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI)©</measure>
    <time_frame>8, 15, 29 days after first dosing</time_frame>
    <description>Comparing each of active group &amp; Placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Film Break-Up Time</measure>
    <time_frame>8, 15, 29 days after first dosing</time_frame>
    <description>Comparing each of active group &amp; Placebo.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>1, 8, 15, 29 days</time_frame>
    <description>Change or shifts from Baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Biomicroscopy Using the Slit-lamp</measure>
    <time_frame>1, 8, 15, 29 days</time_frame>
    <description>Change or shifts from Baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Event Query</measure>
    <time_frame>1, 8, 15, 29 days</time_frame>
    <description>Frequencies</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Biomicroscopy Using the Undilated Fundoscopy</measure>
    <time_frame>1, 29 days</time_frame>
    <description>Change or shifts from Baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">601</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>RGN-259</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>It is composed of the same excipients as RGN-259 but does not contain Tβ4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RGN-259</intervention_name>
    <description>A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days</description>
    <arm_group_label>RGN-259</arm_group_label>
    <other_name>Tβ4</other_name>
    <other_name>Thymosin Beta 4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>It is composed of the same excipients as RGN-259 but does not contain Tβ4</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Vehicle Control</other_name>
  </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 for at least 6 months&#xD;
&#xD;
          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any clinically significant slit-lamp findings at Visit 1 that may include active&#xD;
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active&#xD;
             ocular allergies that require therapeutic treatment, and/or in the opinion of the&#xD;
             investigator may interfere with study parameters;&#xD;
&#xD;
          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active&#xD;
             ocular inflammation at Visit 1;&#xD;
&#xD;
          -  Have ab uncontrolled systemic disease:&#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>Ora Clinical Research and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover, MA</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>November 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>November 5, 2021</results_first_submitted>
  <results_first_submitted_qc>December 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2022</results_first_posted>
  <disposition_first_submitted>October 22, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 22, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 28, 2020</disposition_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye Syndrome</keyword>
  <keyword>Dry Eye</keyword>
  <keyword>DES</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>
  <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>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02974907/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>August 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02974907/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened during a 14-day study run-in period prior to randomization. And after run-in period and confirmation of inclusion and exclusion criteria, all eligible subjects were randomized in a 1:1 ratio to receive 0.1% RGN-259 or placebo ophthalmic solution bilaterally, four times per day (QID) for 28 days. The study comprised of 5 visits over the course of approximately 6 weeks.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>RGN-259</title>
          <description>Active (0.1% RGN-259 ophthalmic solution)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo (Placebo 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="299"/>
                <participants group_id="P2" count="302"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="286"/>
                <participants group_id="P2" count="292"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RGN-259</title>
          <description>Active (0.1% RGN-259 ophthalmic solution)</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo (Placebo ophthalmic solution)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="299"/>
            <count group_id="B2" value="302"/>
            <count group_id="B3" value="601"/>
          </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="61.9" spread="11.97"/>
                    <measurement group_id="B2" value="63.0" spread="11.48"/>
                    <measurement group_id="B3" value="62.5" spread="11.73"/>
                  </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="215"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="438"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="163"/>
                  </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="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="278"/>
                    <measurement group_id="B3" value="553"/>
                  </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="1"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </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="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="246"/>
                    <measurement group_id="B3" value="497"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Discomfort</title>
        <description>Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)</description>
        <time_frame>29 days after first dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RGN-259</title>
            <description>Active (0.1% RGN-259 ophthalmic solution)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Placebo ophthalmic solution)</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Discomfort</title>
          <description>Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="299"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" lower_limit="-0.05" upper_limit="0.19"/>
                    <measurement group_id="O2" value="-0.04" lower_limit="-0.15" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corneal Fluorescein Staining</title>
        <description>Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)</description>
        <time_frame>29 days after first dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RGN-259</title>
            <description>Active (0.1% RGN-259 ophthalmic solution)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Placebo ophthalmic solution)</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Fluorescein Staining</title>
          <description>Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" lower_limit="-0.06" upper_limit="0.20"/>
                    <measurement group_id="O2" value="-0.01" lower_limit="-0.13" upper_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corneal Fluorescein Staining</title>
        <description>Comparing each of active group &amp; Placebo.</description>
        <time_frame>8, 15, 29 days after first dosing</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unanesthetized Schirmer's Test</title>
        <description>Comparing each of active group &amp; Placebo.</description>
        <time_frame>29 days after first dosing</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Surface Disease Index (OSDI)©</title>
        <description>Comparing each of active group &amp; Placebo.</description>
        <time_frame>8, 15, 29 days after first dosing</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tear Film Break-Up Time</title>
        <description>Comparing each of active group &amp; Placebo.</description>
        <time_frame>8, 15, 29 days after first dosing</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Visual Acuity</title>
        <description>Change or shifts from Baseline</description>
        <time_frame>1, 8, 15, 29 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Biomicroscopy Using the Slit-lamp</title>
        <description>Change or shifts from Baseline</description>
        <time_frame>1, 8, 15, 29 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Event Query</title>
        <description>Frequencies</description>
        <time_frame>1, 8, 15, 29 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Biomicroscopy Using the Undilated Fundoscopy</title>
        <description>Change or shifts from Baseline</description>
        <time_frame>1, 29 days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected at every visit through study completion, up to Day 29.</time_frame>
      <desc>There was no anticipated/unanticipated deaths due to any cause in this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>RGN-259</title>
          <description>Active (0.1% RGN-259 ophthalmic solution)</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo (Placebo 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="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </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="19" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Acuity Reduced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="299"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </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>Shinwook Kang</name_or_title>
      <organization>ReGenTree, LLC</organization>
      <phone>609-649-5505</phone>
      <email>swkang@regentreellc.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/NCT02974907
org study id: RGN-259/16-110-0008
nct id: NCT02974907
lead sponsor: 
has dmc: No
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Dry eye can be caused by many variable factors. Some examples include hormonal changes due to
      aging, or living in an environment of low humidity for long periods of time. Dry eye is a
      complex disease that may result in symptoms like discomfort, visual disturbance, and dryness.
      Patients with dry eye often have damage on the surface of the eye. In previous studies,
      RGN-259 has been shown to promote healing of the surface of the eye and decrease
      inflammation. It suggests that RGN-259 has a significant potential to be an important new
      safe and effective therapeutic in the treatment of dry eye syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ocular Discomfort
time frame: 29 days after first dosing
description: Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)
measure: Corneal Fluorescein Staining
time frame: 29 days after first dosing
description: Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)
measure: Corneal Fluorescein Staining
time frame: 8, 15, 29 days after first dosing
description: Comparing each of active group & Placebo.
measure: Unanesthetized Schirmer's Test
time frame: 29 days after first dosing
description: Comparing each of active group & Placebo.
measure: Ocular Surface Disease Index (OSDI)©
time frame: 8, 15, 29 days after first dosing
description: Comparing each of active group & Placebo.
measure: Tear Film Break-Up Time
time frame: 8, 15, 29 days after first dosing
description: Comparing each of active group & Placebo.
measure: Visual Acuity
time frame: 1, 8, 15, 29 days
description: Change or shifts from Baseline
measure: Change in Biomicroscopy Using the Slit-lamp
time frame: 1, 8, 15, 29 days
description: Change or shifts from Baseline
measure: Adverse Event Query
time frame: 1, 8, 15, 29 days
description: Frequencies
measure: Change in Biomicroscopy Using the Undilated Fundoscopy
time frame: 1, 29 days
description: Change or shifts from Baseline
arm group label: RGN-259
arm group type: Experimental
description: RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
arm group label: Placebo
arm group type: Placebo Comparator
description: It is composed of the same excipients as RGN-259 but does not contain Tβ4
intervention type: Drug
intervention name: RGN-259
description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
arm group label: RGN-259
other name: Tβ4
other name: Thymosin Beta 4
intervention type: Drug
intervention name: Placebo
description: It is composed of the same excipients as RGN-259 but does not contain Tβ4
arm group label: Placebo
other name: Vehicle Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gail Torkildsen, MD
role: Principal Investigator
affiliation: Ora Clinical Research and Development
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 