<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/NCT01693315</url>
  </required_header>
  <id_info>
    <org_study_id>AMA0076-201</org_study_id>
    <nct_id>NCT01693315</nct_id>
  </id_info>
  <brief_title>Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma</brief_title>
  <official_title>A Phase 2a, Randomized, Double-masked, Placebo-controlled, Dose-escalation Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amakem, NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amakem, NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this dose-escalation study is to evaluate the safety, tolerability and&#xD;
      efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension&#xD;
      or primary open-angle glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intraocular pressure change from baseline.</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events as a measure of safety/tolerability</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP assessments at weekly visits</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <condition>Eye Disease</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - AMA0076 Dose A (or vehicle)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: AMA0076 Dose B (or vehicle)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: AMA0076 Dose C (or vehicle)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: AMA0076 Dose D (or vehicle)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMA0076</intervention_name>
    <arm_group_label>Cohort 1 - AMA0076 Dose A (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 2: AMA0076 Dose B (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 3: AMA0076 Dose C (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 4: AMA0076 Dose D (or vehicle)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Cohort 1 - AMA0076 Dose A (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 2: AMA0076 Dose B (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 3: AMA0076 Dose C (or vehicle)</arm_group_label>
    <arm_group_label>Cohort 4: AMA0076 Dose D (or vehicle)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria include:&#xD;
&#xD;
          1. Adults 30-85 years of age&#xD;
&#xD;
          2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes&#xD;
&#xD;
          3. Not receiving medication for IOP, or able to stop such medication for a washout period&#xD;
             and the duration of the study without significant risk of adverse consequences related&#xD;
             to glaucomatous disease&#xD;
&#xD;
          4. Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on&#xD;
             Screening Two visit and Baseline visit in one or both eyes off treatment&#xD;
&#xD;
        Exclusion Criteria include:&#xD;
&#xD;
          1. Uncontrolled intraocular hypertension defined as &gt;34 mm Hg at either of the&#xD;
             screening/baseline visits (after a washout phase in those subjects who were currently&#xD;
             receiving ocular hypotensive therapy).&#xD;
&#xD;
          2. Receiving more than one medication for IOP at time of screening.&#xD;
&#xD;
          3. Central corneal thickness of less than 500 µm or greater than 620 µm.&#xD;
&#xD;
          4. BCVA worse than 20/200 in either eye&#xD;
&#xD;
          5. Significant visual field loss (ie, mean deviation &gt; 10 db or field loss within 10&#xD;
             degrees of fixation), a new field defect, or progression of an existing field defect&#xD;
             in either eye during the year preceding the study.&#xD;
&#xD;
          6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in&#xD;
             either eye.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Artesia Clinical Site - Site 02</name>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inglewood Clinical Site - Site 03</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petaluma Clinical Site - Site 05</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Haven Clinical Site - Site 01</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Clinical Site - Site 04</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Site - Site 06</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>July 16, 2013</last_update_submitted>
  <last_update_submitted_qc>July 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2013</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>Eye Diseases</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01693315
org study id: AMA0076-201
nct id: NCT01693315
lead sponsor: 
has dmc: No
The objective of this dose-escalation study is to evaluate the safety, tolerability and
      efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension
      or primary open-angle glaucoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: intraocular pressure change from baseline.
time frame: 4 weeks
measure: Adverse events as a measure of safety/tolerability
time frame: 4 weeks
measure: IOP assessments at weekly visits
time frame: Weeks 1, 2, 3, 4
arm group label: Cohort 1 - AMA0076 Dose A (or vehicle)
arm group type: Experimental
description: Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).
arm group label: Cohort 2: AMA0076 Dose B (or vehicle)
arm group type: Experimental
description: Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo).
arm group label: Cohort 3: AMA0076 Dose C (or vehicle)
arm group type: Experimental
description: Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).
arm group label: Cohort 4: AMA0076 Dose D (or vehicle)
arm group type: Experimental
description: Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo).
intervention type: Drug
intervention name: AMA0076
arm group label: Cohort 1 - AMA0076 Dose A (or vehicle)
arm group label: Cohort 2: AMA0076 Dose B (or vehicle)
arm group label: Cohort 3: AMA0076 Dose C (or vehicle)
arm group label: Cohort 4: AMA0076 Dose D (or vehicle)
intervention type: Drug
intervention name: Placebo
arm group label: Cohort 1 - AMA0076 Dose A (or vehicle)
arm group label: Cohort 2: AMA0076 Dose B (or vehicle)
arm group label: Cohort 3: AMA0076 Dose C (or vehicle)
arm group label: Cohort 4: AMA0076 Dose D (or vehicle)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Eye Diseases
mesh term: Ocular Hypertension
mesh term: Hypertension