<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/NCT01668524</url>
  </required_header>
  <id_info>
    <org_study_id>ATS907-205</org_study_id>
    <nct_id>NCT01668524</nct_id>
  </id_info>
  <brief_title>ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects</brief_title>
  <official_title>A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altheos, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Altheos, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single-site, dose-escalation study will evaluate safety and tolerability of increasing&#xD;
      concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular&#xD;
      Hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Single Arm: ATS907</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-cohort, dose-escalation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATS907</intervention_name>
    <description>Single dose of each of three increasing concentrations</description>
    <arm_group_label>Single Arm: ATS907</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or greater&#xD;
&#xD;
          -  Diagnosis of open angle glaucoma or ocular hypertension in both eyes&#xD;
&#xD;
          -  Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic&#xD;
             Retinopathy Study (EDTRS) in each eye (equivalent to 20/200)&#xD;
&#xD;
          -  Must be willing to discontinue the use of all ocular hypotensive medications in both&#xD;
             eyes prior to and during the entire course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ophthalmic (in either eye):&#xD;
&#xD;
          -  Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or&#xD;
             history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser&#xD;
             procedures in study eye(s). Refractive surgery in study eye&#xD;
&#xD;
          -  Cataract surgery and or other intraocular surgery within one month prior to Screening&#xD;
             in either eye&#xD;
&#xD;
          -  History within 3 months prior to Screening of clinically significant moderate or&#xD;
             severe chronic or active ocular infection, inflammation, blepharitis, dermatitis,&#xD;
             uveitis or conjunctivitis&#xD;
&#xD;
          -  Clinically significant corneal dystrophy, epithelial and or endothelial disease,&#xD;
             corneal irregularities and or scarring such that reliable applanation tonometry would&#xD;
             prevented&#xD;
&#xD;
          -  Contact lens wear during the duration of the study&#xD;
&#xD;
          -  Clinically significant ocular disease (e.g., diabetic retinopathy, macular&#xD;
             degeneration, or uveitis) which might interfere or progress during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sall Research Medical Center</name>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <zip>90701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</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>
  <!-- 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/NCT01668524
org study id: ATS907-205
nct id: NCT01668524
lead sponsor: 
has dmc: No
This single-site, dose-escalation study will evaluate safety and tolerability of increasing
      concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular
      Hypertension
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs
time frame: 3 weeks
arm group label: Single Arm: ATS907
arm group type: Experimental
description: Single-cohort, dose-escalation
intervention type: Drug
intervention name: ATS907
description: Single dose of each of three increasing concentrations
arm group label: Single Arm: ATS907
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension