<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/NCT02979054</url>
  </required_header>
  <id_info>
    <org_study_id>LT4020-302</org_study_id>
    <nct_id>NCT02979054</nct_id>
  </id_info>
  <brief_title>Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratoires Thea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratoires Thea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the performance and safety of T4020 versus saline&#xD;
      solution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3</measure>
    <time_frame>Day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4</measure>
    <time_frame>Day 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corneal Epithelial Defect Size Assessment</measure>
    <time_frame>Baseline and Day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>T4020</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop every other day during 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 drop every other day during 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>T4020</intervention_name>
    <arm_group_label>T4020</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Saline solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients diagnosed with progressive keratoconus&#xD;
&#xD;
          -  Patients who signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under 18 years&#xD;
&#xD;
          -  History within 1 month or any active ocular infection, ocular injury, and associated&#xD;
             corneal ulceration and abscess&#xD;
&#xD;
          -  Corneal thickness&lt; 400µm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes Üniversitesi Tıp Fakültesi</name>
      <address>
        <city>Kayseri</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>France</country>
    <country>Spain</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>July 16, 2019</results_first_submitted>
  <results_first_submitted_qc>September 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2019</results_first_posted>
  <last_update_submitted>October 11, 2019</last_update_submitted>
  <last_update_submitted_qc>October 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
  </condition_browse>
  <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 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02979054/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>157 screened patients disposed as: 135 patients treated and randomised, 20 patients not included (reasons: screen failures: 14, protocol violation: 1, consent withdrawal: 4 and other reasons: 1) and 2 patients treated but not randomised.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>T4020</title>
          <description>1 drop every other day during 5 days&#xD;
T4020</description>
        </group>
        <group group_id="P2">
          <title>Saline Solution</title>
          <description>1 drop every other day during 5 days&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>T4020</title>
          <description>1 drop every other day during 5 days&#xD;
T4020</description>
        </group>
        <group group_id="B2">
          <title>Saline Solution</title>
          <description>1 drop every other day during 5 days&#xD;
Placebo</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="71"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="135"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" spread="7.9"/>
                    <measurement group_id="B2" value="28.9" spread="10.2"/>
                    <measurement group_id="B3" value="28.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3</title>
        <time_frame>Day 3</time_frame>
        <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
        <group_list>
          <group group_id="O1">
            <title>T4020</title>
            <description>1 drop every other day during 5 days&#xD;
T4020</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution</title>
            <description>1 drop every other day during 5 days&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3</title>
          <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4</title>
        <time_frame>Day 4</time_frame>
        <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
        <group_list>
          <group group_id="O1">
            <title>T4020</title>
            <description>1 drop every other day during 5 days&#xD;
T4020</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution</title>
            <description>1 drop every other day during 5 days&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4</title>
          <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corneal Epithelial Defect Size Assessment</title>
        <time_frame>Baseline and Day 5</time_frame>
        <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
        <group_list>
          <group group_id="O1">
            <title>T4020</title>
            <description>1 drop every other day during 5 days&#xD;
T4020</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution</title>
            <description>1 drop every other day during 5 days&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Epithelial Defect Size Assessment</title>
          <population>mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.</population>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="4.6"/>
                    <measurement group_id="O2" value="1.9" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events</title>
        <time_frame>Through study completion, an average of 1 month</time_frame>
        <population>Safety set (137 treated participants)</population>
        <group_list>
          <group group_id="O1">
            <title>T4020</title>
            <description>1 drop every other day during 5 days&#xD;
T4020</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution</title>
            <description>1 drop every other day during 5 days&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events</title>
          <population>Safety set (137 treated participants)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first visit to the final visit performed by the patient + 1 month later, assessed up to 95 days</time_frame>
      <desc>Safety set: 137 participants. 137 treated participants: 73 treated patients withT4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.mITT set (135 participants) analysed results.</desc>
      <group_list>
        <group group_id="E1">
          <title>T4020</title>
          <description>1 drop every other day during 5 days&#xD;
T4020</description>
        </group>
        <group group_id="E2">
          <title>Saline Solution</title>
          <description>1 drop every other day during 5 days&#xD;
Placebo</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="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Contact lens intolerance</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Corneal disorder</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Corneal infiltrates</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Corneal oedema</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Corneal opacity</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Systemic Non Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malabsorption from application site</sub_title>
                <description>Ocular adverse events</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <description>Systemic Non Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <description>Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <description>Systemic Non Ocular adverse event</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Systemic Non Ocular adverse event</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </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>All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Development Director</name_or_title>
      <organization>Laboratoires Théa</organization>
      <phone>+33(0)473981414</phone>
      <email>Corentin.LECAMUS@theapharma.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/NCT02979054
org study id: LT4020-302
nct id: NCT02979054
lead sponsor: 
has dmc: No
The purpose of this study is to assess the performance and safety of T4020 versus saline
      solution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
time frame: Day 3
measure: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
time frame: Day 4
measure: Corneal Epithelial Defect Size Assessment
time frame: Baseline and Day 5
measure: Number of Participants With Treatment-emergent Adverse Events
time frame: Through study completion, an average of 1 month
arm group label: T4020
arm group type: Experimental
description: 1 drop every other day during 5 days
arm group label: Saline solution
arm group type: Placebo Comparator
description: 1 drop every other day during 5 days
intervention type: Device
intervention name: T4020
arm group label: T4020
intervention type: Device
intervention name: Placebo
arm group label: Saline solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: France
country: Spain
country: Turkey
responsible party type: Sponsor
mesh term: Keratoconus
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 