<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/NCT04445519</url>
  </required_header>
  <id_info>
    <org_study_id>NCX-470-02</org_study_id>
    <nct_id>NCT04445519</nct_id>
  </id_info>
  <brief_title>Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension</brief_title>
  <acronym>Mont Blanc</acronym>
  <official_title>Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicox Ophthalmics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nicox Ophthalmics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical study is to evaluate the safety and efficacy of NCX 470&#xD;
      Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular&#xD;
      hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial,&#xD;
      subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%)&#xD;
      or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be&#xD;
      randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">September 16, 2022</completion_date>
  <primary_completion_date type="Actual">September 16, 2022</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>Double (Participant, Investigator)</masking>
    <masking_description>double-masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction from baseline IOP in the study eye</measure>
    <time_frame>3 months</time_frame>
    <description>Mean IOP reduction from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction from baseline in diurnal IOP in the study eye</measure>
    <time_frame>3 months</time_frame>
    <description>Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and incidence of treatment-emergent adverse events</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of discontinuation</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">670</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>NCX 470 0.065%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCX 470 0.1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost 0.005%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCX 470 0.1% (remainder of trial)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost 0.005% (remainder of trial)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NCX 470 0.065% (initial phase of trial)</intervention_name>
    <description>NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)</description>
    <arm_group_label>NCX 470 0.065%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost 0.005% (initial phase of trial)</intervention_name>
    <description>Latanoprost Ophthalmic Solution, 0.005%</description>
    <arm_group_label>Latanoprost 0.005%</arm_group_label>
    <other_name>Latanoprost</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NCX 470 0.1% (initial phase of trial)</intervention_name>
    <description>NCX 470 Ophthalmic Solution, 0.1%</description>
    <arm_group_label>NCX 470 0.1%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NCX 470 0.1% (remainder of trial)</intervention_name>
    <description>NCX 470 Ophthalmic Solution, 0.1%</description>
    <arm_group_label>NCX 470 0.1% (remainder of trial)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost 0.005% (remainder of trial)</intervention_name>
    <description>Latanoprost Ophthalmic Solution, 0.005%</description>
    <arm_group_label>Latanoprost 0.005% (remainder of trial)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of open-angle glaucoma or ocular hypertension in both eyes&#xD;
&#xD;
          -  Qualifying IOP at 3 time points through the day at 2 visits following washout of&#xD;
             IOP-lowering medication, if applicable&#xD;
&#xD;
          -  Qualifying best-corrected visual acuity in each eye&#xD;
&#xD;
          -  Ability to provide informed consent and follow study instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Narrow anterior chamber angles or disqualifying corneal thickness in either eye&#xD;
&#xD;
          -  Clinically significant ocular disease in either eye&#xD;
&#xD;
          -  Previous complicated surgery or certain types of glaucoma surgery in either eye&#xD;
&#xD;
          -  Incisional ocular surgery or severe trauma in either eye within the past 6 months&#xD;
&#xD;
          -  Uncontrolled systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicox Ophthalmics, Inc.</last_name>
    <role>Study Director</role>
    <affiliation>Nicox Ophthalmics, Inc.</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <disposition_first_submitted>September 21, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>September 21, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 28, 2022</disposition_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 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>Latanoprost</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04445519
org study id: NCX-470-02
nct id: NCT04445519
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
      Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular
      hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial,
      subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%)
      or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be
      randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: double-masked
measure: Reduction from baseline IOP in the study eye
time frame: 3 months
description: Mean IOP reduction from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye
measure: Reduction from baseline in diurnal IOP in the study eye
time frame: 3 months
description: Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
measure: Frequency and incidence of treatment-emergent adverse events
time frame: 3 months
measure: Rate of discontinuation
time frame: 3 months
arm group label: NCX 470 0.065%
arm group type: Experimental
description: NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)
arm group label: NCX 470 0.1%
arm group type: Experimental
description: NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
arm group label: Latanoprost 0.005%
arm group type: Active Comparator
description: Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
arm group label: NCX 470 0.1% (remainder of trial)
arm group type: Experimental
description: NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)
arm group label: Latanoprost 0.005% (remainder of trial)
arm group type: Active Comparator
description: Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
intervention type: Drug
intervention name: NCX 470 0.065% (initial phase of trial)
description: NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
arm group label: NCX 470 0.065%
intervention type: Drug
intervention name: Latanoprost 0.005% (initial phase of trial)
description: Latanoprost Ophthalmic Solution, 0.005%
arm group label: Latanoprost 0.005%
other name: Latanoprost
intervention type: Drug
intervention name: NCX 470 0.1% (initial phase of trial)
description: NCX 470 Ophthalmic Solution, 0.1%
arm group label: NCX 470 0.1%
intervention type: Drug
intervention name: NCX 470 0.1% (remainder of trial)
description: NCX 470 Ophthalmic Solution, 0.1%
arm group label: NCX 470 0.1% (remainder of trial)
intervention type: Drug
intervention name: Latanoprost 0.005% (remainder of trial)
description: Latanoprost Ophthalmic Solution, 0.005%
arm group label: Latanoprost 0.005% (remainder of trial)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Nicox Ophthalmics, Inc.
role: Study Director
affiliation: Nicox Ophthalmics, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Latanoprost
sharing ipd: No