<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/NCT04498169</url>
  </required_header>
  <id_info>
    <org_study_id>AR-13324-CS210</org_study_id>
    <nct_id>NCT04498169</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy</brief_title>
  <acronym>Fuchs</acronym>
  <official_title>A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerie Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerie Pharmaceuticals</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>
      Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their&#xD;
      efficacy in reducing or resolving corneal edema in subjects with FCD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2020</start_date>
  <completion_date type="Actual">August 11, 2021</completion_date>
  <primary_completion_date type="Actual">August 11, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central Corneal Thickness (CCT)</measure>
    <time_frame>Baseline &amp; 4 weeks</time_frame>
    <description>Mean change from baseline in CCT by ultrasound pachymetry</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Corneal Edema</condition>
  <arm_group>
    <arm_group_label>Once Daily Netarsudil Ophthalmic Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Twice Daily Netarsudil Ophthalmic Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netarsudil Ophthalmic</intervention_name>
    <description>Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
    <arm_group_label>Once Daily Netarsudil Ophthalmic Solution</arm_group_label>
    <other_name>Rhopressa®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netarsudil Ophthalmic</intervention_name>
    <description>Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
    <arm_group_label>Twice Daily Netarsudil Ophthalmic Solution</arm_group_label>
    <other_name>Rhopressa®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults aged 18 years or older&#xD;
&#xD;
          2. Documented diagnosis of FCD&#xD;
&#xD;
          3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline&#xD;
             Visit, in the eligible eye(s)&#xD;
&#xD;
          4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the&#xD;
             eligible eye(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be&#xD;
             required in the study eligible eye(s) within the study period&#xD;
&#xD;
          2. Clinically significant ocular disease (other than FCD) or trauma in the eligible&#xD;
             eye(s) which could interfere with study interpretation&#xD;
&#xD;
          3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal&#xD;
             refractive surgery in the eligible eye(s)&#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>Michelle Senchyna, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Aerie Pharmaceuticals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orange County Ophthalmology</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Eye Associates</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Eye Associates</name>
      <address>
        <city>South Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Vision Institute</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Care</name>
      <address>
        <city>Minnetonka</city>
        <state>Minnesota</state>
        <zip>55305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Associates</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>W. Fargo</city>
        <state>North Dakota</state>
        <zip>58078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Eye Care</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Eye Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Eye Consultants</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>August 10, 2022</results_first_submitted>
  <results_first_submitted_qc>August 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2022</results_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corneal Edema</keyword>
  <keyword>Fuchs Corneal Dystrophy</keyword>
  <keyword>Netarsudil Ophthalmic Solution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Dystrophies, Hereditary</mesh_term>
    <mesh_term>Corneal Edema</mesh_term>
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
    <mesh_term>Edema</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>February 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04498169/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>September 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04498169/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment took place at 12 clinic sites in the United States between September 2020 and June 2021.</recruitment_details>
      <pre_assignment_details>All participants underwent a washout of their pre-study treatment for Fuchs Corneal Dystrophy for a period of 24 hours prior to the baseline visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Once Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
        </group>
        <group group_id="P2">
          <title>Twice Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Modified Intent-to-Treat Population</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Safety Population</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Per-Protocol Population</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Study Completion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>40 participants were randomized; 20 each to the Netarsudil QD and the Netarsudil BID arms. 1 participant discontinued from each arm due to adverse events.&#xD;
40 participants were included in both the mITT population for the primary endpoint analysis and the safety population for safety analysis.&#xD;
6 participants were excluded from the per-protocol analysis due to protocol deviations (2 in the Netarsudil QD arm, 4 in the Netarsudil BID arm). There were no Covid-19 related protocol deviations.</population>
      <group_list>
        <group group_id="B1">
          <title>Once Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
        </group>
        <group group_id="B2">
          <title>Twice Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile 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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </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="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Central Corneal Thickness (CCT)</title>
        <description>Mean change from baseline in CCT by ultrasound pachymetry</description>
        <time_frame>Baseline &amp; 4 weeks</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Once Daily Netarsudil Ophthalmic Solution</title>
            <description>One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>Twice Daily Netarsudil Ophthalmic Solution</title>
            <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Central Corneal Thickness (CCT)</title>
          <description>Mean change from baseline in CCT by ultrasound pachymetry</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>µm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.4" spread="35.72"/>
                    <measurement group_id="O2" value="-20.1" spread="39.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.</non_inferiority_desc>
            <p_value>0.0021</p_value>
            <method>One-sample t-test (within group)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were documented from the time of signing the informed consent until the last study visit for each participant. This was a period of approximately 8 weeks (56 days) for participants who completed the full study duration. For AEs ongoing at the time of study completion, the ongoing AE was followed-up and the participant was provided appropriate medical care until the event resolved or stabilized, the participant was lost to follow-up, or there was other resolution to the event.</time_frame>
      <desc>Adverse events information was collected at all study visits.</desc>
      <group_list>
        <group group_id="E1">
          <title>Once Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution</description>
        </group>
        <group group_id="E2">
          <title>Twice Daily Netarsudil Ophthalmic Solution</title>
          <description>One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.&#xD;
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile 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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Viral gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="5" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal verticillata</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Conjunctival hypaeremia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </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>Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs.</name_or_title>
      <organization>Aerie Pharmaceuticals Inc.</organization>
      <phone>+1 908-947-3551</phone>
      <email>msenchyna@aeriepharma.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/NCT04498169
org study id: AR-13324-CS210
nct id: NCT04498169
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their
      efficacy in reducing or resolving corneal edema in subjects with FCD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Central Corneal Thickness (CCT)
time frame: Baseline & 4 weeks
description: Mean change from baseline in CCT by ultrasound pachymetry
arm group label: Once Daily Netarsudil Ophthalmic Solution
arm group type: Experimental
description: One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
arm group label: Twice Daily Netarsudil Ophthalmic Solution
arm group type: Experimental
description: One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.
intervention type: Drug
intervention name: Netarsudil Ophthalmic
description: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
arm group label: Once Daily Netarsudil Ophthalmic Solution
other name: Rhopressa®
intervention type: Drug
intervention name: Netarsudil Ophthalmic
description: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
arm group label: Twice Daily Netarsudil Ophthalmic Solution
other name: Rhopressa®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle Senchyna, Ph.D.
role: Study Director
affiliation: Aerie Pharmaceuticals Inc.
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Corneal Dystrophies, Hereditary
mesh term: Corneal Edema
mesh term: Fuchs' Endothelial Dystrophy
mesh term: Edema
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 