<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/NCT04405245</url>
  </required_header>
  <id_info>
    <org_study_id>AKB-9778-CI-OS-2001</org_study_id>
    <nct_id>NCT04405245</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma</brief_title>
  <official_title>Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EyePoint Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EyePoint Pharmaceuticals, Inc.</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>
      This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study&#xD;
      assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic&#xD;
      Solution 4.0% administered once (AM) or twice (AM &amp; PM) daily when used as an adjunctive&#xD;
      therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated&#xD;
      IOP due to OAG or OHT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">November 5, 2020</completion_date>
  <primary_completion_date type="Actual">November 5, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)</measure>
    <time_frame>Baseline to Day 14</time_frame>
    <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</measure>
    <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
    <description>Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</measure>
    <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
    <description>Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Observed IOP at Each Time Point on Days 14 and 28</measure>
    <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
    <description>Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline IOP at Each Time Point on Days 14 and 28</measure>
    <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
    <description>Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28</measure>
    <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
    <description>Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28</measure>
    <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
    <description>Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Primary Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>AKB-9778 4% QD + Latanoprost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AKB-9778 4% BID + Latanoprost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Twice Daily + Latanoprost</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost ophthalmic solution</intervention_name>
    <description>Latanoprost opthalmic solution to be dosed once daily</description>
    <arm_group_label>AKB-9778 4% BID + Latanoprost</arm_group_label>
    <arm_group_label>AKB-9778 4% QD + Latanoprost</arm_group_label>
    <arm_group_label>Placebo Twice Daily + Latanoprost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AKB-9778 4%</intervention_name>
    <description>Razuprotafib opthalmic solution</description>
    <arm_group_label>AKB-9778 4% BID + Latanoprost</arm_group_label>
    <arm_group_label>AKB-9778 4% QD + Latanoprost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo for razuprotafib opthalmic solution</description>
    <arm_group_label>Placebo Twice Daily + Latanoprost</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is&#xD;
             acceptable)&#xD;
&#xD;
          -  Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for&#xD;
             a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP&#xD;
             lowering eyedrop&#xD;
&#xD;
          -  IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit&#xD;
&#xD;
          -  Following 4 week washout period, IOP ≥ 24 mmHg and &lt; 36 mmHg at 08:00 hour and IOP ≥&#xD;
             22 mmHg and &lt; 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant ocular disease which might interfere with interpretation of the&#xD;
             study efficacy endpoints or with safety assessments&#xD;
&#xD;
          -  Pseudoexfoliation or pigment dispersion component glaucoma&#xD;
&#xD;
          -  History of angle closure glaucoma, or narrow angles or with evidence of peripheral&#xD;
             anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to&#xD;
             Screening&#xD;
&#xD;
          -  Intraocular pressure ≥ 36 mmHg&#xD;
&#xD;
          -  Cup/disc ratio of &gt; 0.8 in either eye&#xD;
&#xD;
          -  Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10&#xD;
             degrees of fixation in either eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>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>North Valley Eye Medical Group</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</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>Shettle Eye Research</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clayton Eye Clinical Research, LLC</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Research Associates</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannarr Eye Care</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of America Eye Care, P.A.</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</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>North Valley Eye Medical 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 &amp; Throat Assoc. (CEENTA)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James D. Branch, MD Ophthalmology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abrams Eye Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mark J. Weiss, MD, 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 Assoc</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Specialists</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advancing Vision Research</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texan Eye / Keystone Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>September 21, 2022</results_first_submitted>
  <results_first_submitted_qc>May 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2023</results_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</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>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Ocular Hypertension</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>
    <mesh_term>Latanoprost</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04405245/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AKB-9778 4% QD + Latanoprost</title>
          <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
AKB-9778: AKB-9778 4% ophthalmic solution</description>
        </group>
        <group group_id="P2">
          <title>AKB-9778 4% BID + Latanoprost</title>
          <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
AKB-9778: AKB-9778 4% ophthalmic solution</description>
        </group>
        <group group_id="P3">
          <title>Placebo BID + Latanoprost</title>
          <description>• Placebo for AKB-9778 4% ophthalmic solution BID (AM &amp; PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
Placebo: placebo for AKB-9778 4% ophthalmic solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Each Baseline participant contributed one study eye and one fellow eye</population>
      <group_list>
        <group group_id="B1">
          <title>AKB-9778 4% QD + Latanoprost</title>
          <description>• AKB-9778 4%(AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: razuprotafib opthalmic solution</description>
        </group>
        <group group_id="B2">
          <title>AKB-9778 4% BID + Latanoprost</title>
          <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: razuprotafib opthalmic solution</description>
        </group>
        <group group_id="B3">
          <title>Placebo Twice Daily + Latanoprost</title>
          <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for razuprotafib opthalmic solution</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="65"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="64"/>
            <count group_id="B4" value="194"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
            <count group_id="B2" value="130"/>
            <count group_id="B3" value="128"/>
            <count group_id="B4" value="388"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.3" spread="8.81"/>
                    <measurement group_id="B2" value="65.6" spread="10.85"/>
                    <measurement group_id="B3" value="65.9" spread="10.55"/>
                    <measurement group_id="B4" value="66.6" spread="10.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="176"/>
                  </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>
          <units_analyzed>Participants</units_analyzed>
          <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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="139"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis</title>
          <description>Study Eye must meet ALL ophthalmic inclusion and no exclusion criteria; Fellow Eye is the non-Study Eye. Fellow Eye may meet ophthalmic inclusion and exclusion criteria, but is not required.</description>
          <units>Eyes</units>
          <param>Count of Units</param>
          <units_analyzed>Eyes</units_analyzed>
          <class_list>
            <class>
              <title>Open-angle glaucoma - Study Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular hypertension - Study Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Open-angle glaucoma - Fellow Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular hypertension - Fellow Eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Randomization Intraocular Pressure (Study Eye)</title>
          <description>Only the Study Eye of the 65 participants was measured in this table</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Diurnal Mean &lt; 26 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diurnal Mean &gt;=26 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study Eye Screening Corneal Thickness (micrometers)</title>
          <description>Only the Study Eye of the 65 participants was measured in this table</description>
          <units>micrometer</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="544.8" spread="30.27"/>
                    <measurement group_id="B2" value="554.0" spread="28.57"/>
                    <measurement group_id="B3" value="554.7" spread="30.58"/>
                    <measurement group_id="B4" value="551.2" spread="30.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study Eye Screening Intraocular Pressure (mmHg)</title>
          <description>Only the Study Eye of the 65 participants was measured in this table</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.34" spread="1.981"/>
                    <measurement group_id="B2" value="20.54" spread="2.283"/>
                    <measurement group_id="B3" value="20.11" spread="2.003"/>
                    <measurement group_id="B4" value="20.33" spread="2.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Study Eye Baseline Diurnal Mean Intraocular Pressure (mmHg)</title>
          <description>Only the Study Eye of the 65 participants was measured in this table</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.83" spread="1.559"/>
                    <measurement group_id="B2" value="25.16" spread="2.039"/>
                    <measurement group_id="B3" value="25.11" spread="1.967"/>
                    <measurement group_id="B4" value="25.03" spread="1.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)</title>
        <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)</title>
          <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.95" spread="0.258"/>
                    <measurement group_id="O2" value="-7.95" spread="0.257"/>
                    <measurement group_id="O3" value="-7.04" spread="0.259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8070</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.366</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0130</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.365</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)</title>
        <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population</description>
        <time_frame>Baseline to Day 14</time_frame>
        <population>The Intent-to-Treat population includes all randomized subjects who received at least one dose of study medication. the primary population for efficacy analyses and was used to summarize all efficacy variables and summarizes subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)</title>
          <description>Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population</description>
          <population>The Intent-to-Treat population includes all randomized subjects who received at least one dose of study medication. the primary population for efficacy analyses and was used to summarize all efficacy variables and summarizes subjects as randomized.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.75" spread="0.259"/>
                    <measurement group_id="O2" value="-7.62" spread="0.258"/>
                    <measurement group_id="O3" value="-7.03" spread="0.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</title>
        <description>Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population</description>
        <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</title>
          <description>Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.68" spread="0.250"/>
                    <measurement group_id="O2" value="-7.53" spread="0.250"/>
                    <measurement group_id="O3" value="-6.91" spread="0.252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.83" spread="0.255"/>
                    <measurement group_id="O2" value="-7.86" spread="0.255"/>
                    <measurement group_id="O3" value="-6.93" spread="0.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</title>
        <description>Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population</description>
        <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)</title>
          <description>Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.01" spread="2.445"/>
                    <measurement group_id="O2" value="17.37" spread="2.272"/>
                    <measurement group_id="O3" value="17.95" spread="2.383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.86" spread="2.514"/>
                    <measurement group_id="O2" value="17.03" spread="2.019"/>
                    <measurement group_id="O3" value="17.92" spread="2.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Observed IOP at Each Time Point on Days 14 and 28</title>
        <description>Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population</description>
        <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Observed IOP at Each Time Point on Days 14 and 28</title>
          <description>Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</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="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.54" spread="2.970"/>
                    <measurement group_id="O2" value="18.25" spread="2.652"/>
                    <measurement group_id="O3" value="18.75" spread="3.289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.98" spread="2.907"/>
                    <measurement group_id="O2" value="17.32" spread="2.772"/>
                    <measurement group_id="O3" value="18.02" spread="2.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.50" spread="3.059"/>
                    <measurement group_id="O2" value="17.25" spread="2.767"/>
                    <measurement group_id="O3" value="17.87" spread="2.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.52" spread="2.805"/>
                    <measurement group_id="O2" value="17.17" spread="2.762"/>
                    <measurement group_id="O3" value="17.56" spread="2.696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.81" spread="2.977"/>
                    <measurement group_id="O2" value="18.13" spread="2.417"/>
                    <measurement group_id="O3" value="18.95" spread="2.986"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.97" spread="2.878"/>
                    <measurement group_id="O2" value="17.02" spread="2.558"/>
                    <measurement group_id="O3" value="17.90" spread="2.986"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.60" spread="2.791"/>
                    <measurement group_id="O2" value="16.55" spread="2.695"/>
                    <measurement group_id="O3" value="17.51" spread="2.914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.35" spread="2.507"/>
                    <measurement group_id="O2" value="16.97" spread="2.377"/>
                    <measurement group_id="O3" value="17.82" spread="3.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline IOP at Each Time Point on Days 14 and 28</title>
        <description>Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
        <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline IOP at Each Time Point on Days 14 and 28</title>
          <description>Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</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="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.66" spread="2.551"/>
                    <measurement group_id="O2" value="-8.13" spread="3.225"/>
                    <measurement group_id="O3" value="-7.59" spread="3.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.02" spread="2.607"/>
                    <measurement group_id="O2" value="-7.88" spread="2.831"/>
                    <measurement group_id="O3" value="-7.45" spread="2.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.79" spread="2.378"/>
                    <measurement group_id="O2" value="-7.52" spread="2.761"/>
                    <measurement group_id="O3" value="-6.83" spread="2.381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.29" spread="2.698"/>
                    <measurement group_id="O2" value="-7.10" spread="2.841"/>
                    <measurement group_id="O3" value="-6.36" spread="2.332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.39" spread="2.977"/>
                    <measurement group_id="O2" value="-8.25" spread="2.826"/>
                    <measurement group_id="O3" value="-7.38" spread="2.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.03" spread="2.665"/>
                    <measurement group_id="O2" value="-8.19" spread="2.536"/>
                    <measurement group_id="O3" value="-7.57" spread="2.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.69" spread="2.383"/>
                    <measurement group_id="O2" value="-8.21" spread="2.486"/>
                    <measurement group_id="O3" value="-7.18" spread="2.598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.45" spread="2.279"/>
                    <measurement group_id="O2" value="-7.30" spread="2.731"/>
                    <measurement group_id="O3" value="-6.10" spread="2.593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28</title>
        <description>Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
        <time_frame>Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28</title>
          <description>Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.52" spread="1.292"/>
                    <measurement group_id="O2" value="-30.41" spread="1.291"/>
                    <measurement group_id="O3" value="-28.68" spread="1.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.09" spread="1.221"/>
                    <measurement group_id="O2" value="-31.10" spread="1.219"/>
                    <measurement group_id="O3" value="-29.29" spread="1.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.21" spread="1.213"/>
                    <measurement group_id="O2" value="-30.19" spread="1.211"/>
                    <measurement group_id="O3" value="-27.53" spread="1.219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.48" spread="1.285"/>
                    <measurement group_id="O2" value="-28.94" spread="1.287"/>
                    <measurement group_id="O3" value="-26.61" spread="1.293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 08:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.19" spread="1.218"/>
                    <measurement group_id="O2" value="-30.96" spread="1.218"/>
                    <measurement group_id="O3" value="-27.93" spread="1.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 10:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.12" spread="1.207"/>
                    <measurement group_id="O2" value="-32.36" spread="1.205"/>
                    <measurement group_id="O3" value="-29.70" spread="1.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.65" spread="1.209"/>
                    <measurement group_id="O2" value="-33.09" spread="1.206"/>
                    <measurement group_id="O3" value="-29.03" spread="1.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28, 16:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.21" spread="1.227"/>
                    <measurement group_id="O2" value="-29.65" spread="1.229"/>
                    <measurement group_id="O3" value="-25.58" spread="1.235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28</title>
        <description>Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population</description>
        <time_frame>Baseline to Day 14 and Baseline to Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28</title>
          <description>Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</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="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.08" spread="7.875"/>
                    <measurement group_id="O2" value="-30.29" spread="8.550"/>
                    <measurement group_id="O3" value="-28.16" spread="7.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.83" spread="8.711"/>
                    <measurement group_id="O2" value="-31.67" spread="7.219"/>
                    <measurement group_id="O3" value="-28.19" spread="8.523"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels</title>
        <description>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>AKB-9778 4% QD + Latanoprost</title>
            <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
razuprotafib: razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>AKB-9778 4% BID + Latanoprost</title>
            <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Razuprotafib: Razuprotafib opthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>Placebo Twice Daily + Latanoprost</title>
            <description>• Placebo for AKB-9778 4% twice daily (AM &amp; PM) plus latanoprost daily (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily&#xD;
Placebo: placebo for Razuprotafib opthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels</title>
          <description>Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population</description>
          <population>The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Subjects Achieving Pre-Specified Mean IOP: &lt;=22 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Subjects Achieving Pre-Specified Mean IOP: &lt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Subjects Achieving Pre-Specified Mean IOP: &lt;=18 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Subjects Achieving Pre-Specified Mean IOP: &lt;=16 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Subjects Achieving Pre-Specified Mean IOP : &lt;=14 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=2 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=3 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=4 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=6 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=8 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : &gt;=10 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=10%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=15%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=20%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=35%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): &gt;=40%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks.</time_frame>
      <desc>The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>AKB-9778 4% QD + Latanoprost</title>
          <description>• AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
AKB-9778: AKB-9778 4% ophthalmic solution</description>
        </group>
        <group group_id="E2">
          <title>AKB-9778 4% BID + Latanoprost</title>
          <description>• AKB-9778 4% BID (AM &amp; PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
AKB-9778: AKB-9778 4% ophthalmic solution</description>
        </group>
        <group group_id="E3">
          <title>Placebo BID + Latanoprost</title>
          <description>• Placebo for AKB-9778 4% ophthalmic solution BID (AM &amp; PM) plus latanoprost QD (PM) for 28 days&#xD;
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily&#xD;
Placebo: placebo for AKB-9778 4% ophthalmic solution</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA version 23.0</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="30" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="40" subjects_affected="26" subjects_at_risk="65"/>
                <counts group_id="E2" events="63" subjects_affected="39" subjects_at_risk="65"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dry Eye</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eye Pruritus</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eyelid margin crusting</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Punctate keratitis</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Retinal artery emoblism</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vitreous disorder</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Glossodynia</sub_title>
                <description>non-ocular TEAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>non-ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site foreign body sensation</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Instillation site pruritis</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>non-ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <description>ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <description>non-ocular TEAE</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>non-ocular TEAE</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Product acquired from Aerpio with limited transfer of documents. Site CTAs not provided.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Bauer</name_or_title>
      <organization>EyePoint Pharmaceuticals, Inc</organization>
      <phone>8573410747</phone>
      <email>dbauer@eyepointpharma.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/NCT04405245
org study id: AKB-9778-CI-OS-2001
nct id: NCT04405245
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study
      assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic
      Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive
      therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated
      IOP due to OAG or OHT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
time frame: Baseline to Day 28
description: Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
measure: Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
time frame: Baseline to Day 14
description: Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population
measure: Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
time frame: Baseline to Day 14 and Baseline to Day 28
description: Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population
measure: Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
time frame: Baseline to Day 14 and Baseline to Day 28
description: Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population
measure: Mean Observed IOP at Each Time Point on Days 14 and 28
time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
description: Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population
measure: Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
description: Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
measure: Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
description: Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
measure: Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
time frame: Baseline to Day 14 and Baseline to Day 28
description: Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population
measure: Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
time frame: Baseline to Day 28
description: Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population
arm group label: AKB-9778 4% QD + Latanoprost
arm group type: Experimental
description: • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
arm group label: AKB-9778 4% BID + Latanoprost
arm group type: Experimental
description: • AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
arm group label: Placebo Twice Daily + Latanoprost
arm group type: Placebo Comparator
description: • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
intervention type: Drug
intervention name: Latanoprost ophthalmic solution
description: Latanoprost opthalmic solution to be dosed once daily
arm group label: AKB-9778 4% BID + Latanoprost
arm group label: AKB-9778 4% QD + Latanoprost
arm group label: Placebo Twice Daily + Latanoprost
intervention type: Drug
intervention name: AKB-9778 4%
description: Razuprotafib opthalmic solution
arm group label: AKB-9778 4% BID + Latanoprost
arm group label: AKB-9778 4% QD + Latanoprost
intervention type: Drug
intervention name: Placebo
description: placebo for razuprotafib opthalmic solution
arm group label: Placebo Twice Daily + Latanoprost
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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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: Hypertension
mesh term: Ophthalmic Solutions
mesh term: Latanoprost
sharing ipd: No
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