<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/NCT03255798</url>
  </required_header>
  <id_info>
    <org_study_id>GCF-041</org_study_id>
    <nct_id>NCT03255798</nct_id>
  </id_info>
  <brief_title>A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra</brief_title>
  <acronym>GCF-041</acronym>
  <official_title>A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glaukos Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glaukos Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation&#xD;
      iStents and one iStent Supra&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two&#xD;
      Second Generation Microbypass Stents and One Suprachoroidal Stent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 6, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>G2 and G3</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>IOP outcome is masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>20% IOP reduction</measure>
    <time_frame>Month 12</time_frame>
    <description>IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP less than or equal to 18 mm Hg</measure>
    <time_frame>Month 12</time_frame>
    <description>IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>G2 and G3 implantation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Two iStent inject stents and one iStent Supra stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>G2 and G3</intervention_name>
    <description>Two iStent inject devices and one iStent supra device</description>
    <arm_group_label>G2 and G3 implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle&#xD;
             glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive&#xD;
             medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or&#xD;
             equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal&#xD;
             iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP&#xD;
             at baseline between 21 and 45 mm Hg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye&#xD;
             Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200&#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>Kerry Stephens, OD</last_name>
    <role>Study Chair</role>
    <affiliation>Glaukos Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prof. Dr. med. Carl Erb</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255798
org study id: GCF-041
nct id: NCT03255798
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation
      iStents and one iStent Supra
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two
      Second Generation Microbypass Stents and One Suprachoroidal Stent
allocation: N/A
intervention model: Single Group Assignment
intervention model description: G2 and G3
primary purpose: Treatment
masking: None (Open Label)
masking description: IOP outcome is masked
measure: 20% IOP reduction
time frame: Month 12
description: IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg
measure: IOP less than or equal to 18 mm Hg
time frame: Month 12
description: IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg
arm group label: G2 and G3 implantation
arm group type: Other
description: Two iStent inject stents and one iStent Supra stent
intervention type: Device
intervention name: G2 and G3
description: Two iStent inject devices and one iStent supra device
arm group label: G2 and G3 implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kerry Stephens, OD
role: Study Chair
affiliation: Glaukos Corporation
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No