<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/NCT01731002</url>
  </required_header>
  <id_info>
    <org_study_id>AR-13324-CS202</org_study_id>
    <nct_id>NCT01731002</nct_id>
  </id_info>
  <brief_title>Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure</brief_title>
  <official_title>A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison&#xD;
      of AR-13324 to latanoprost&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure (IOP)</measure>
    <time_frame>Study treatment was administered for 28 days</time_frame>
    <description>The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent of Exposure</measure>
    <time_frame>28 Days</time_frame>
    <description>Exposure to study medication in days for all treatment groups.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>AR-13324 Ophthalmic Solution 0.01%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop to study eye once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR-13324 Ophthalmic Solution 0.02%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop to study eye once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost Ophthalmic Solution 0.005%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 drop to study eye once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR-13324 Ophthalmic Solution 0.01%</intervention_name>
    <description>Administered to study eye, once daily (QD) in the evening (PM) for 28 days</description>
    <arm_group_label>AR-13324 Ophthalmic Solution 0.01%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR-13324 Ophthalmic Solution 0.02%</intervention_name>
    <description>Administered to study eye, QD in the PM for 28 days</description>
    <arm_group_label>AR-13324 Ophthalmic Solution 0.02%</arm_group_label>
    <other_name>Netarsudil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost ophthalmic solution 0.005%</intervention_name>
    <description>Administered to study eye, QD in the PM for 28 days</description>
    <arm_group_label>Latanoprost Ophthalmic Solution 0.005%</arm_group_label>
    <other_name>Latanoprost</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or greater.&#xD;
&#xD;
          2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).&#xD;
&#xD;
          3. Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility&#xD;
             visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the&#xD;
             second qualification visit. If only one eye meets the IOP criteria it must be the same&#xD;
             eye that met the criteria at all the qualification timepoints.&#xD;
&#xD;
          4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye&#xD;
             (equivalent to 20/200).&#xD;
&#xD;
          5. Able and willing to give signed informed consent and follow study instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ophthalmic&#xD;
&#xD;
          1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure&#xD;
             or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.&#xD;
&#xD;
          2. IOP &gt; 36 mm Hg.&#xD;
&#xD;
          3. Known hypersensitivity to any component of the formulation (benzalkonium chloride,&#xD;
             etc.), or to topical anesthetics.&#xD;
&#xD;
          4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s,&#xD;
             e.g., laser trabeculoplasty).&#xD;
&#xD;
          5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive&#xD;
             keratectomy (PRK), laser eye surgery (LASIK), etc.).&#xD;
&#xD;
          6. Ocular trauma within the past six months, or ocular surgery or laser treatment within&#xD;
             the past three months prior to screening.&#xD;
&#xD;
          7. Evidence of ocular infection, inflammation, clinically significant blepharitis or&#xD;
             conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis&#xD;
&#xD;
          8. Ocular medication of any kind within 30 days of Visit 0, with the exception of a)&#xD;
             ocular hypotensive medications (which must be washed out according to the provided&#xD;
             schedule), b) lid scrubs (which may be used prior to, but not after Visit 0) or c)&#xD;
             lubricating drops for dry eye (which may be used throughout the study).&#xD;
&#xD;
          9. Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis&#xD;
             sicca) which might interfere with the study, including glaucomatous damage so severe&#xD;
             that washout of ocular hypotensive medications for one month is not judged safe (i.e.,&#xD;
             cup-disc ratio &gt; 0.8).&#xD;
&#xD;
         10. Central corneal thickness greater than 600 µm.&#xD;
&#xD;
         11. Any abnormality preventing reliable applanation tonometry of either eye.&#xD;
&#xD;
             Systemic:&#xD;
&#xD;
         12. Clinically significant abnormalities (as determined by the treating physician) in&#xD;
             laboratory tests at screening.&#xD;
&#xD;
         13. Known hypersensitivity or contraindication to latanoprost.&#xD;
&#xD;
         14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal,&#xD;
             endocrine or cardiovascular disorders) which might interfere with the study.&#xD;
&#xD;
         15. Participation in any investigational study within 30 days prior to screening.&#xD;
&#xD;
         16. Changes of systemic medication that could have a substantial effect on IOP within 30&#xD;
             days prior to screening, or anticipated during the study.&#xD;
&#xD;
         17. Due to the current status of the preclinical safety program, women of childbearing&#xD;
             potential who are pregnant, nursing, planning a pregnancy, or not using a medically&#xD;
             acceptable form of birth control. An adult woman is considered to be of childbearing&#xD;
             potential unless she is one year post-menopausal or three months post-surgical&#xD;
             sterilization. All females of childbearing potential must have a negative urine&#xD;
             pregnancy test result at the screening examination and must not intend to become&#xD;
             pregnant during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa Heah, MD</last_name>
    <role>Study Director</role>
    <affiliation>Aerie Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kenneth Sall, M.D.</name>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <zip>90701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Research Institute</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aesthetic Eye Care Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Eye Associates</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre For Health Care</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clayton Eye Center</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</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>Bradley Kwapiszeski, MD</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taustine Eye Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alan L Robin, M.D.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seidenberg Protzko Eye Associates</name>
      <address>
        <city>Havre De Grace</city>
        <state>Maryland</state>
        <zip>21078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Eye Care</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Long Island</name>
      <address>
        <city>Lynbrook</city>
        <state>New York</state>
        <zip>11563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Ophthalmological Group</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Eye Ear Nose and Throat</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael E. Tepedino, M.D.</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Institute</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texan Eye</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>Medical Center Ophth. Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78731</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>June 2016</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>January 22, 2018</results_first_submitted>
  <results_first_submitted_qc>March 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2018</results_first_posted>
  <disposition_first_submitted>February 17, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>February 17, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 17, 2014</disposition_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Latanoprost</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AR-13324 Ophthalmic Solution 0.01%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="P2">
          <title>AR-13324 Ophthalmic Solution 0.02%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="P3">
          <title>Latanoprost Ophthalmic Solution 0.005%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="72"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Test Agent Discontinuation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Uncontrolled Intraocular Pressure (IOP)</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Elevated IOP</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inappropriate use of study medications</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AR-13324 Ophthalmic Solution 0.01%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="B2">
          <title>AR-13324 Ophthalmic Solution 0.02%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="B3">
          <title>Latanoprost Ophthalmic Solution 0.005%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="77"/>
            <count group_id="B4" value="224"/>
          </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="63.5" spread="11.54"/>
                    <measurement group_id="B2" value="66.3" spread="10.25"/>
                    <measurement group_id="B3" value="65.7" spread="11.82"/>
                    <measurement group_id="B4" value="65.1" spread="11.26"/>
                  </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="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="92"/>
                  </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="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraocular Pressure (IOP)</title>
        <description>The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.</description>
        <time_frame>Study treatment was administered for 28 days</time_frame>
        <population>Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)</population>
        <group_list>
          <group group_id="O1">
            <title>AR-13324 Ophthalmic Solution 0.01%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
          <group group_id="O2">
            <title>AR-13324 Ophthalmic Solution 0.02%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
          <group group_id="O3">
            <title>Latanoprost Ophthalmic Solution 0.005%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
        </group_list>
        <measure>
          <title>Intraocular Pressure (IOP)</title>
          <description>The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.</description>
          <population>Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0, 0800 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.34" spread="3.529"/>
                    <measurement group_id="O2" value="27.11" spread="3.031"/>
                    <measurement group_id="O3" value="26.78" spread="2.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0, 1000 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.55" spread="3.411"/>
                    <measurement group_id="O2" value="25.41" spread="3.024"/>
                    <measurement group_id="O3" value="25.18" spread="2.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0, 1600 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.49" spread="3.128"/>
                    <measurement group_id="O2" value="24.29" spread="2.602"/>
                    <measurement group_id="O3" value="24.58" spread="2.515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, 0800 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.89" spread="4.672"/>
                    <measurement group_id="O2" value="21.15" spread="4.047"/>
                    <measurement group_id="O3" value="20.03" spread="3.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 0800 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.24" spread="4.295"/>
                    <measurement group_id="O2" value="20.80" spread="3.679"/>
                    <measurement group_id="O3" value="19.30" spread="3.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 1000 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.28" spread="3.581"/>
                    <measurement group_id="O2" value="18.88" spread="3.461"/>
                    <measurement group_id="O3" value="18.09" spread="2.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 1600 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.90" spread="3.578"/>
                    <measurement group_id="O2" value="18.72" spread="3.585"/>
                    <measurement group_id="O3" value="17.86" spread="2.977"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 0800 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.95" spread="4.717"/>
                    <measurement group_id="O2" value="21.24" spread="4.034"/>
                    <measurement group_id="O3" value="19.24" spread="2.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 1000 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.69" spread="4.358"/>
                    <measurement group_id="O2" value="19.53" spread="3.726"/>
                    <measurement group_id="O3" value="18.40" spread="2.994"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 1600 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.82" spread="3.281"/>
                    <measurement group_id="O2" value="19.13" spread="3.656"/>
                    <measurement group_id="O3" value="18.34" spread="3.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Extent of Exposure</title>
        <description>Exposure to study medication in days for all treatment groups.</description>
        <time_frame>28 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AR-13324 Ophthalmic Solution 0.01%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
          <group group_id="O2">
            <title>AR-13324 Ophthalmic Solution 0.02%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
          <group group_id="O3">
            <title>Latanoprost Ophthalmic Solution 0.005%</title>
            <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
          </group>
        </group_list>
        <measure>
          <title>Extent of Exposure</title>
          <description>Exposure to study medication in days for all treatment groups.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" spread="4.07"/>
                    <measurement group_id="O2" value="26.8" spread="4.6"/>
                    <measurement group_id="O3" value="27.8" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AR-13324 Ophthalmic Solution 0.01%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="E2">
          <title>AR-13324 Ophthalmic Solution 0.02%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
        <group group_id="E3">
          <title>Latanoprost Ophthalmic Solution 0.005%</title>
          <description>1 drop to study eye once daily (QD) in the evening (PM)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <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="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <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="43" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Ocular Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Foreign Body Sensation in Eyes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="77"/>
              </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>Nancy Ramirez-Davis, Director of Clinical Project Management</name_or_title>
      <organization>Aerie Pharmaceuticals, Inc.</organization>
      <phone>908-947-3543</phone>
      <email>nramirez@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/NCT01731002
org study id: AR-13324-CS202
nct id: NCT01731002
lead sponsor: 
has dmc: No
Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison
      of AR-13324 to latanoprost
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Intraocular Pressure (IOP)
time frame: Study treatment was administered for 28 days
description: The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
measure: Extent of Exposure
time frame: 28 Days
description: Exposure to study medication in days for all treatment groups.
arm group label: AR-13324 Ophthalmic Solution 0.01%
arm group type: Experimental
description: 1 drop to study eye once daily
arm group label: AR-13324 Ophthalmic Solution 0.02%
arm group type: Experimental
description: 1 drop to study eye once daily
arm group label: Latanoprost Ophthalmic Solution 0.005%
arm group type: Active Comparator
description: 1 drop to study eye once daily
intervention type: Drug
intervention name: AR-13324 Ophthalmic Solution 0.01%
description: Administered to study eye, once daily (QD) in the evening (PM) for 28 days
arm group label: AR-13324 Ophthalmic Solution 0.01%
intervention type: Drug
intervention name: AR-13324 Ophthalmic Solution 0.02%
description: Administered to study eye, QD in the PM for 28 days
arm group label: AR-13324 Ophthalmic Solution 0.02%
other name: Netarsudil
intervention type: Drug
intervention name: Latanoprost ophthalmic solution 0.005%
description: Administered to study eye, QD in the PM for 28 days
arm group label: Latanoprost Ophthalmic Solution 0.005%
other name: Latanoprost
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Theresa Heah, MD
role: Study Director
affiliation: Aerie Pharmaceuticals, Inc.
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Pharmaceutical Solutions
mesh term: Latanoprost
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 