<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/NCT03808688</url>
  </required_header>
  <id_info>
    <org_study_id>MA-RHO-18-002</org_study_id>
    <nct_id>NCT03808688</nct_id>
  </id_info>
  <brief_title>Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting</brief_title>
  <official_title>A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerie Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerie Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as&#xD;
      monotherapy or when used concomitantly with other IOP-lowering agents in subjects with&#xD;
      elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical&#xD;
      setting. The study is an open-label design. The patients will receive treatment for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">July 26, 2019</completion_date>
  <primary_completion_date type="Actual">July 26, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure (IOP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.&#xD;
Prostaglandin analog (PGA). Fixed dose combination (FDC).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Netarsudil Ophthalmic Solution 0.02%</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netarsudil Ophthalmic Solution 0.02%</intervention_name>
    <description>1 drop in each eye once daily in the evening</description>
    <arm_group_label>Netarsudil Ophthalmic Solution 0.02%</arm_group_label>
    <other_name>Rhopressa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects (aged 18 or older)&#xD;
&#xD;
          2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by&#xD;
             the treating physician to require additional intraocular pressure (IOP)-lowering&#xD;
             treatment with netarsudil 0.02%.&#xD;
&#xD;
          3. Willingness to follow protocol requirements, including signed informed consent,&#xD;
             routine follow-up schedule, completing questionnaires and completing laboratory tests&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Have any active ocular disease other than glaucoma or ocular hypertension that would&#xD;
             interfere with study interpretation&#xD;
&#xD;
          2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and&#xD;
             not using a medically acceptable form of birth control. Male subjects with a female&#xD;
             partner of childbearing potential must have had a prior vasectomy or agree to use an&#xD;
             effective method of birth control during the treatment period and for 3 months after&#xD;
             the subject has completed the study.&#xD;
&#xD;
          3. Known sensitivity or allergy to the study medication or components&#xD;
&#xD;
          4. Any systemic disease or clinical evidence of any condition which would make the&#xD;
             subject, in the opinion of the investigator, unsuitable for the study or could&#xD;
             potentially confound the study results&#xD;
&#xD;
          5. Concurrent participation or prior participation in any investigational drug or device&#xD;
             study within the last 30 days prior to the Baseline Visit&#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>David Hollander, MD, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Aerie Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlantis Eyecare</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</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>North Bay Eye Associates, Inc</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shettle Eye Research Inc</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center For Sight</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34238</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Research Associates, LLC</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheaton Eye Clinic, Ltd</name>
      <address>
        <city>Wheaton</city>
        <state>Illinois</state>
        <zip>60187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stiles Eyecare Excellence and Glaucoma Institute, PA</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaddie Eye Centers, LLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glaucoma Consultants</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekwani Vision Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mark J. Weiss, M.D., Inc.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; Christie and Associates, PC</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Eye Professionals, LLC</name>
      <address>
        <city>Huntingdon Valley</city>
        <state>Pennsylvania</state>
        <zip>19006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Cataract &amp; Laser Center</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care, PA</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VRF Eye Specialty Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advancing Vision Research</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cataract &amp; Glaucoma Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</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>The Eye Centers of Racine and Kenosha</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <results_first_submitted>August 3, 2020</results_first_submitted>
  <results_first_submitted_qc>September 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 29, 2020</results_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</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>Glaucoma</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_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>December 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03808688/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 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03808688/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.</recruitment_details>
      <pre_assignment_details>The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment &amp; Pre-assignment sections.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Netarsudil Ophthalmic Solution 0.02% Monotherapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening.</description>
        </group>
        <group group_id="P2">
          <title>Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intolerance to Conjunctival Hyperemia</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>IOP Too High</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>IOP Too High, Nerve/Visual Field Changes</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Visit Out of Window</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medication Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified intent to treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.</population>
      <group_list>
        <group group_id="B1">
          <title>Netarsudil Ophthalmic Solution 0.02% Monotherapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening.</description>
        </group>
        <group group_id="B2">
          <title>Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.</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="91"/>
            <count group_id="B2" value="151"/>
            <count group_id="B3" value="242"/>
          </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="67.2" spread="11.85"/>
                    <measurement group_id="B2" value="67.2" spread="10.53"/>
                    <measurement group_id="B3" value="67.2" spread="11.02"/>
                  </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="57"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="94"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="179"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraocular Pressure (IOP)</title>
        <description>Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.&#xD;
Prostaglandin analog (PGA). Fixed dose combination (FDC).</description>
        <time_frame>12 weeks</time_frame>
        <population>Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline</title>
            <description>During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Treatment naïve at baseline visit. 1 drop in each eye once daily in the evening.</description>
          </group>
          <group group_id="O2">
            <title>Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent</title>
            <description>During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 1 agent at baseline visit (majority were PGA replacements). 1 drop in each eye once daily in the evening.</description>
          </group>
          <group group_id="O3">
            <title>Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents</title>
            <description>During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 2 agents at baseline visit (including PGA and FDC replacements). 1 drop in each eye once daily in the evening.</description>
          </group>
          <group group_id="O4">
            <title>Netarsudil Ophth Sol 0.02% Concomitant Therapy</title>
            <description>During study Netarsudil Ophthalmic Solution 0.02% - Used concomitantly with other IOP lowering agents (2-5 total agents used). 1 drop in each eye once daily in the evening.</description>
          </group>
        </group_list>
        <measure>
          <title>Intraocular Pressure (IOP)</title>
          <description>Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.&#xD;
Prostaglandin analog (PGA). Fixed dose combination (FDC).</description>
          <population>Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.9" spread="16.35"/>
                    <measurement group_id="O2" value="-2.3" spread="16.23"/>
                    <measurement group_id="O3" value="0.2" spread="8.81"/>
                    <measurement group_id="O4" value="-17.0" spread="16.81"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cohorts assessed versus baseline treatment</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.</non_inferiority_desc>
            <other_analysis_desc>All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected during the course of the 12-week treatment period.</time_frame>
      <desc>The safety population included all subjects who received at least 1 dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Netarsudil Ophthalmic Solution 0.02% Monotherapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening.</description>
        </group>
        <group group_id="E2">
          <title>Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy</title>
          <description>Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Non-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="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis Lower Left Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant Melanoma of Eyelid</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Hyperemia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="99"/>
                <counts group_id="E2" events="32" subjects_affected="32" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="99"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Conjunctival Hemorrage</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="99"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Instillation Site Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="99"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="161"/>
              </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>VP, Medical Affairs</name_or_title>
      <organization>Aerie Pharmaceuticals</organization>
      <phone>949-246-8731</phone>
      <email>jmwilliams@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/NCT03808688
org study id: MA-RHO-18-002
nct id: NCT03808688
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as
      monotherapy or when used concomitantly with other IOP-lowering agents in subjects with
      elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical
      setting. The study is an open-label design. The patients will receive treatment for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraocular Pressure (IOP)
time frame: 12 weeks
description: Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.
Prostaglandin analog (PGA). Fixed dose combination (FDC).
arm group label: Netarsudil Ophthalmic Solution 0.02%
arm group type: Other
intervention type: Drug
intervention name: Netarsudil Ophthalmic Solution 0.02%
description: 1 drop in each eye once daily in the evening
arm group label: Netarsudil Ophthalmic Solution 0.02%
other name: Rhopressa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Hollander, MD, MBA
role: Study Director
affiliation: Aerie Pharmaceuticals, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Glaucoma, Open-Angle
mesh term: Hypertension
mesh term: Ophthalmic Solutions
sharing ipd: No
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