<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/NCT03284853</url>
  </required_header>
  <id_info>
    <org_study_id>PG324-CS303</org_study_id>
    <nct_id>NCT03284853</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension</brief_title>
  <official_title>A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03% / Timolol 0.5%) Ophthalmic Solution in Subjects With Elevated Intraocular Pressure (MERCURY 3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerie Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerie Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02%&#xD;
      / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP)&#xD;
      in patients with elevated intraocular pressure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">November 6, 2020</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</primary_completion_date>
  <phase>Phase 3</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>Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry</measure>
    <time_frame>Day 90</time_frame>
    <description>Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">436</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Netarsudil/Latanoprost 0.02%/0.005%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GANFORT®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Netarsudil/Latanoprost 0.02%/0.005%</intervention_name>
    <description>Topical sterile ophthalmic solution</description>
    <arm_group_label>Netarsudil/Latanoprost 0.02%/0.005%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GANFORT®</intervention_name>
    <description>Topical sterile ophthalmic solution</description>
    <arm_group_label>GANFORT®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be 18 years of age or older.&#xD;
&#xD;
          2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is&#xD;
             acceptable).&#xD;
&#xD;
          3. Subjects insufficiently controlled and/or subjects considered in need for combination&#xD;
             therapy by the investigators.&#xD;
&#xD;
          4. Medicated intraocular pressure ≥ 17 mmHg in at least one eye and &lt; 28mmHg in both eyes&#xD;
             at screening visit.&#xD;
&#xD;
          5. Unmedicated (post-washout) IOP &gt;20mmHg in at least one eye and &lt; 36mmHg in both eyes&#xD;
             at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification&#xD;
             visit, have IOP &gt;17mmHg in at least one eye and &lt; 36mmHg in both eyes at 10:00 and&#xD;
             16:00 hours. Note: For purposes of determining eligibility of subjects to be enrolled,&#xD;
             the non-integral IOP mean number will be used. Any non-integral mean IOP number should&#xD;
             not be rounded. If only one eye qualifies at the second qualification visit it MUST be&#xD;
             the same eye that qualified on the first visit and this will be the study eye for the&#xD;
             duration of the study.&#xD;
&#xD;
          6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to&#xD;
             20/200 or better Snellen visual acuity in each eye).&#xD;
&#xD;
          7. Be able and willing to give signed informed consent and follow study instruction.&#xD;
&#xD;
          8. Women must be either of non-childbearing potential, or women with childbearing&#xD;
             potential and men with reproductive potential must be willing to practice acceptable&#xD;
             methods of birth control during the study.&#xD;
&#xD;
          9. Women of childbearing potential must have a negative urine pregnancy test within 7&#xD;
             days of first dose of study treatment and agree to use highly effective contraception&#xD;
             during the study and for 3 months after the last dose of study medication.&#xD;
&#xD;
         10. Men with a female partner of childbearing potential must have either had a prior&#xD;
             vasectomy or agree to use an effective form of contraception from time of&#xD;
             randomization and for 3 months following the last dose of study medication.&#xD;
&#xD;
         11. In France, a subject will be eligible for inclusion in this study only if either&#xD;
             affiliated to or as a beneficiary of a social security number.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ophthalmic:&#xD;
&#xD;
          1. Clinically significant ocular disease (e.g., corneal edema, uveitis, or severe&#xD;
             keratoconjunctivitis sicca) which might interfere with interpretation of the study&#xD;
             efficacy endpoints or with safety assessments, including subjects with glaucomatous&#xD;
             damage so severe that washout of ocular hypotensive medications for 4 weeks or longer&#xD;
             if needed is not judged safe as it would put the subject at risk for further vision&#xD;
             loss.&#xD;
&#xD;
          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure&#xD;
             glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow&#xD;
             angle with complete or partial closure. Note: Previous laser peripheral iridotomy is&#xD;
             NOT acceptable.&#xD;
&#xD;
          3. Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are&#xD;
             excluded for this criterion are not allowed to attempt requalification), or use of&#xD;
             more than two ocular hypotensive medications within 30 days of screening. Note: fixed&#xD;
             dose combination medications, for the purpose of this exclusion criterion, count as&#xD;
             one medication. However, subjects currently taking 2 fixed dose combination products&#xD;
             are excluded.&#xD;
&#xD;
          4. Treatment-naïve subjects.&#xD;
&#xD;
          5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve&#xD;
             the target IOP and was considered either a therapeutic failure or to have insufficient&#xD;
             response. Subjects currently (immediately prior to screening visit) being treated with&#xD;
             GANFORT® are excluded from the study.&#xD;
&#xD;
          6. Known hypersensitivity to any component of the investigational formulations to be used&#xD;
             (e.g., benzalkonium chloride) or to fluorescein.&#xD;
&#xD;
          7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye.&#xD;
&#xD;
          8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal&#xD;
             cross-linking, keratoplasty).&#xD;
&#xD;
          9. Ocular trauma within the six months prior to screening, or ocular surgery or&#xD;
             non-refractive laser treatment within the three months prior to screening.&#xD;
&#xD;
         10. Recent or current evidence of ocular infection or inflammation in either eye. Current&#xD;
             evidence of clinically significant blepharitis, conjunctivitis, keratitis, current&#xD;
             evidence or history of herpes simplex or zoster keratitis in either eye at screening.&#xD;
&#xD;
         11. Use of ocular medication in either eye of any kind within 30 days of screening and&#xD;
             throughout the study, with the exception of a) ocular hypotensive medications which&#xD;
             must have been the same medication for 30 days prior to screening (which must be&#xD;
             washed out according to the provided schedule), b) lid scrubs (which may be used prior&#xD;
             to, but not after, screening), c) lubricating drops for dry eye (which may be used&#xD;
             throughout the study), as prescribed by the Investigator.&#xD;
&#xD;
         12. Mean central corneal thickness greater than 620μm at screening.&#xD;
&#xD;
         13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye&#xD;
             (e.g., keratoconus).&#xD;
&#xD;
             Systemic:&#xD;
&#xD;
         14. Clinically significant abnormalities in laboratory tests at screening.&#xD;
&#xD;
         15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product&#xD;
             Medication Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic&#xD;
             obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or&#xD;
             heart rate; second or third-degree heart block or congestive heart failure, cardiac&#xD;
             failure, cardiac shock and severe diabetes).&#xD;
&#xD;
         16. Clinically significant systemic disease which might interfere with the study.&#xD;
&#xD;
         17. Participation in any investigational study within 30 days prior to screening.&#xD;
&#xD;
         18. Systemic medication including corticosteroid containing drugs that could have a&#xD;
             substantial effect on IOP which HAVE NOT been maintained at a consistent dose and&#xD;
             regime within 30 days prior to screening, and are anticipated to change in dose and/or&#xD;
             regime during the study.&#xD;
&#xD;
         19. Use of topical steroid containing medications on the face or in or around the eyes&#xD;
             will exclude the subject (see Section 5.6 Concomitant Medications).&#xD;
&#xD;
         20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or&#xD;
             not using a medically acceptable and highly effective form of birth control. An adult&#xD;
             woman is considered to be of childbearing potential unless she is one year&#xD;
             post-menopausal (1 year without menses with appropriate clinical profile, e.g. age&#xD;
             appropriate, &gt; 45 years in the absence of HRT. In questionable cases the subject must&#xD;
             have FSH value &gt; 40mIU/mL and an estradiol value &lt; 40pg/mL (&lt; 140pmol/L)) or three&#xD;
             months post-surgical sterilization.&#xD;
&#xD;
         21. Vulnerable subjects such as minors, adults under legal protection or unable to express&#xD;
             their consent (e.g. hospitalized persons in coma), persons deprived of liberty&#xD;
             (prisoners from jails), or persons subject to psychiatric care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Senchyna</last_name>
    <role>Study Director</role>
    <affiliation>Aerie Pharmaceuticals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>State Hospital - University Medical Center Academical Department of Ophthalmology</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albertgasse 39/10+11</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch Hospital</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty Hospital Brno Eye Department</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glaucoma center Oční klinika VFN a 1. LF UK</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre ophtalmologique Pole vision val d'ouest</name>
      <address>
        <city>Ecully</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Service - Batiment R Hospital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology department Necker University Hospital-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Freiburg, Eye Center,Killianstr.5, Freiburg i. Breisgau</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitats-Augenklinik, Studienzentrum/Clinical Trials in Opthalmology (CTO)</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Eye Hospital Tuebingen, STC eyetrial at the center for Ophthalmolgy</name>
      <address>
        <city>Tuebingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenarztpraxis Dr. Andreas Bayer</name>
      <address>
        <city>Weilheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budapest Retina Associates</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Ophthalmology Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen, Clinical Center, Ophthalmology Department</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinexpert Gyongyos Kft.</name>
      <address>
        <city>Heves</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Medical Center</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged, Department of Ophthalmology</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markusovszky University Teaching Hospital</name>
      <address>
        <city>Szombathely</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Clinic DiNOGMI University Hospital San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. Ophthalmology, San Raffaele Hospital</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco P.O.L.Sacco</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo - Ophthalmic Clinic</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medicine and Surgery University of Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthamic Clinic of the University of Pavia, IRCCS Foundation San Matteo Policlinic</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Pisana Hospital of Cisanello</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G.B.Bietti Foundation - IRCCS</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senese University Hospital</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C.U Oculistica, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <zip>10146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Eye Clinic Ospedale Maggiore</name>
      <address>
        <city>Trieste</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Signes Ozolinas Doctor Practice in Ophthalmology</name>
      <address>
        <city>Jelgava</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latvian American Eye Centre (LAAC)</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.Stradins Clinical University Hospital, Ophthalmology Clinic</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga East University hospital, In-patient Department &quot;Biķernieki&quot;, Ophthalmology Clinic</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Professor K. Gibinski University Clinical Centre</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Diagnostics and Microsurgery of Glaucoma</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Institute of Medicine Klinika Okulistyki</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Clinic Jasne Blonia</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Oftalmologia Barraquer</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya Ophthalmology Department</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital QuironSalud Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala de retina (ICR) Glaucoma and Investigation Department</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General del S.A.S. de Jerez de la Frontera</name>
      <address>
        <city>Cádiz</city>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía de Córdoba</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Ojos de la Coruña</name>
      <address>
        <city>La Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena Ophthalmology Department</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Torrevieja Ophthalmology Department</name>
      <address>
        <city>Torrevieja</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FISABIO-Oftalmología Médica</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Department Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet Ophthalmology Department</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary</name>
      <address>
        <city>Sunderland</city>
        <state>Tyne And Wear</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Grampian Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Trust</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Department, Queen Alexandra Hospital</name>
      <address>
        <city>Cosham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Cheshire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Crewe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital</name>
      <address>
        <city>Huntingdon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas' NHS Foundation Trust Glaucoma Research Area</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Eye Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital, King's College Hospital NHS</name>
      <address>
        <city>Sidcup</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>November 5, 2021</results_first_submitted>
  <results_first_submitted_qc>December 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2022</results_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</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>Latanoprost</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03284853/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03284853/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment took place in 11 European countries between September 2017 and May 2020.</recruitment_details>
      <pre_assignment_details>All participants underwent a period of washout for their pre-study ocular hypotensive medication for a prescribed period (up to 4 weeks or longer), depending on the medication, before receiving study medication.&#xD;
From the total 436 participants, 6 were not included in the analysis due to serious GCP breaches (2 from the Netarsudil/Latanoprost 0.02%/0.005% arm and 4 from the Ganfort arm).&#xD;
The remaining 430 participants (218 and 212 respectively) were included in the analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Netarsudil/Latanoprost 0.02%/0.005%</title>
          <description>PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.&#xD;
Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution</description>
        </group>
        <group group_id="P2">
          <title>GANFORT®</title>
          <description>GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.&#xD;
GANFORT®: Topical sterile 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="218"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-Protocol Population</title>
              <participants_list>
                <participants group_id="P1" count="169"/>
                <participants group_id="P2" count="170"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="199"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disallowed Concurrent Medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other - Reason not reported in CSR</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>436 participants were randomized; 220 to the Netarsudil/Latanoprost 0.02%/0.005% arm and 216 to the Ganfort arm.&#xD;
From the total 436 participants, 6 were not included in the analysis due to serious GCP breaches (see Pre-Assignment Details for more information).</population>
      <group_list>
        <group group_id="B1">
          <title>Netarsudil/Latanoprost 0.02%/0.005%</title>
          <description>PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.&#xD;
Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution</description>
        </group>
        <group group_id="B2">
          <title>GANFORT®</title>
          <description>GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.&#xD;
GANFORT®: Topical sterile ophthalmic solution</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="218"/>
            <count group_id="B2" value="212"/>
            <count group_id="B3" value="430"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Participants were randomized on a 1:1 ratio to either group. Age was not a consideration for group assignment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Participants were randomized on a 1:1 ratio to either group. Age was not a consideration for group assignment.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Mean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" lower_limit="25" upper_limit="91"/>
                    <measurement group_id="B2" value="67.0" lower_limit="22" upper_limit="91"/>
                    <measurement group_id="B3" value="67.2" lower_limit="22" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Participants were randomized on a 1:1 ratio to either group. Gender was not a consideration for group assignment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="210"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="410"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry</title>
        <description>Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.</description>
        <time_frame>Day 90</time_frame>
        <population>A total of 430 (100%) participants were included in the Safety and Intent-to-Treat populations.</population>
        <group_list>
          <group group_id="O1">
            <title>Netarsudil/Latanoprost 0.02%/0.005%</title>
            <description>PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.&#xD;
Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>GANFORT®</title>
            <description>GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.&#xD;
GANFORT®: Topical sterile ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry</title>
          <description>Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.</description>
          <population>A total of 430 (100%) participants were included in the Safety and Intent-to-Treat populations.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="218"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.39" lower_limit="15.09" upper_limit="15.84"/>
                    <measurement group_id="O2" value="15.56" lower_limit="15.42" upper_limit="15.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.64" lower_limit="15.18" upper_limit="16.20"/>
                    <measurement group_id="O2" value="15.25" lower_limit="15.16" upper_limit="15.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.61" lower_limit="15.28" upper_limit="15.93"/>
                    <measurement group_id="O2" value="15.19" lower_limit="15.09" upper_limit="15.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were documented for each participant from the time of signing consent until 30 days after the last dose of Investigational Product. This was a maximum period of approximately 9 months (38 weeks) for participants who completed the full study duration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Netarsudil/Latanoprost 0.02%/0.005%</title>
          <description>PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.&#xD;
Netarsudil/Latanoprost 0.02%/0.005%: Topical sterile ophthalmic solution</description>
        </group>
        <group group_id="E2">
          <title>GANFORT®</title>
          <description>GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.&#xD;
GANFORT®: Topical sterile ophthalmic solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Dermoid cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Umbilical hernia repair</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="117" subjects_at_risk="218"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Hyperemia</sub_title>
                <counts group_id="E1" events="72" subjects_affected="72" subjects_at_risk="218"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Cornea Verticillata</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="218"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Conjunctival Hemorrhage</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="218"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Eye Pruritus</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="218"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Punctate Keratitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="218"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="212"/>
              </event>
              <event>
                <sub_title>Conjunctivitis Allergic</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="218"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="218"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="218"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="212"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michelle Senchyna, PhD. Vice President, Clinical Development &amp; Medical Affairs.</name_or_title>
      <organization>Aerie Pharmaceuticals Inc.</organization>
      <phone>+1 908 947 3551</phone>
      <email>msenchyna@aeriepharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284853
org study id: PG324-CS303
nct id: NCT03284853
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02%
      / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP)
      in patients with elevated intraocular pressure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry
time frame: Day 90
description: Comparison of PG324 to Ganfort for mean intraocular pressure at specified timepoints at Week 2, Week 6 and Month 3.
arm group label: Netarsudil/Latanoprost 0.02%/0.005%
arm group type: Experimental
description: PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.
arm group label: GANFORT®
arm group type: Active Comparator
description: GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.
intervention type: Drug
intervention name: Netarsudil/Latanoprost 0.02%/0.005%
description: Topical sterile ophthalmic solution
arm group label: Netarsudil/Latanoprost 0.02%/0.005%
intervention type: Drug
intervention name: GANFORT®
description: Topical sterile ophthalmic solution
arm group label: GANFORT®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle Senchyna
role: Study Director
affiliation: Aerie Pharmaceuticals Inc.
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country: Austria
country: Belgium
country: Czechia
country: France
country: Germany
country: Hungary
country: Italy
country: Latvia
country: Poland
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Latanoprost
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