<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/NCT02226094</url>
  </required_header>
  <id_info>
    <org_study_id>DWT CIP 002</org_study_id>
    <nct_id>NCT02226094</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension</brief_title>
  <official_title>A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OcuTherix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OcuTherix, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT&#xD;
      in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of&#xD;
      the study is to investigate the durability, repeatability, and does response of the same.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra-procedural and post-procedural adverse events</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Primary Open-angle Glaucoma (POAG)</condition>
  <condition>Ocular Hypertension (OHT)</condition>
  <arm_group>
    <arm_group_label>DWT device dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ellex Tango SLT machine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selective Laser Trabeculoplasty (SLT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DWT Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DWT device dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DWT device dose A</intervention_name>
    <description>Deep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments.</description>
    <arm_group_label>DWT device dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ellex Tango SLT machine</intervention_name>
    <description>Laser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage.</description>
    <arm_group_label>Ellex Tango SLT machine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DWT device dose B</intervention_name>
    <description>Same as DWT device dose A except 20 second spot treatments.</description>
    <arm_group_label>DWT device dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DWT sham</intervention_name>
    <description>Same as DWT device dose A except device not applied to ocular surface.</description>
    <arm_group_label>DWT Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects, 18 years or older.&#xD;
&#xD;
          -  Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must&#xD;
             include evidence of:&#xD;
&#xD;
               1. Optic disc or retinal nerve fiber layer structural abnormalities (substantiated&#xD;
                  by OCT); and/or&#xD;
&#xD;
               2. Visual field abnormality (substantiated with the Humphrey automated perimeter&#xD;
                  using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be&#xD;
                  -15dB &lt; MD &lt; 0dB.&#xD;
&#xD;
          -  Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:&#xD;
&#xD;
               1. Greater than or equal to 18mmHg at the Screening Visit or have documented history&#xD;
                  of IOP being greater than or equal to 22mmHg;&#xD;
&#xD;
               2. Greater than or equal to 22mmHg at both Eligibility Visits.&#xD;
&#xD;
          -  Subjects currently using one or more topical medications to control their IOP.&#xD;
&#xD;
          -  Subjects able and willing to comply with the protocol, including randomization&#xD;
             assignment and all follow-up visits.&#xD;
&#xD;
          -  Subjects that sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are pregnant, lactating, or planning to become pregnant during the course&#xD;
             of the study.&#xD;
&#xD;
          -  Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g.,&#xD;
             pseudo exfoliation or pigmentary glaucoma).&#xD;
&#xD;
          -  Other exclusion criteria apply&#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>Harvey Siy Uy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pacific Eye and Laser Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edgar U. Leuenberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian Eye Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria I Yap-Veloso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asian Eye Institute</name>
      <address>
        <city>Makati City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Eye and Laser Institute</name>
      <address>
        <city>Makati City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intra-ocular pressure</keyword>
  <keyword>primary open-angle glaucoma</keyword>
  <keyword>intra ocular pressure</keyword>
  <keyword>primary open angle glaucoma</keyword>
  <keyword>glaucoma</keyword>
  <keyword>deep wave trabeculoplasty</keyword>
  <keyword>ocular hypertension</keyword>
  <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/NCT02226094
org study id: DWT CIP 002
nct id: NCT02226094
lead sponsor: 
has dmc: No
The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT
      in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of
      the study is to investigate the durability, repeatability, and does response of the same.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
time frame: 6 months
measure: Intra-procedural and post-procedural adverse events
time frame: 6 months
arm group label: DWT device dose A
arm group type: Experimental
description: Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).
arm group label: Ellex Tango SLT machine
arm group type: Active Comparator
description: Selective Laser Trabeculoplasty (SLT)
arm group label: DWT Sham
arm group type: Sham Comparator
description: Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.
arm group label: DWT device dose B
arm group type: Experimental
description: Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).
intervention type: Device
intervention name: DWT device dose A
description: Deep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments.
arm group label: DWT device dose A
intervention type: Device
intervention name: Ellex Tango SLT machine
description: Laser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage.
arm group label: Ellex Tango SLT machine
intervention type: Device
intervention name: DWT device dose B
description: Same as DWT device dose A except 20 second spot treatments.
arm group label: DWT device dose B
intervention type: Device
intervention name: DWT sham
description: Same as DWT device dose A except device not applied to ocular surface.
arm group label: DWT Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harvey Siy Uy, MD
role: Principal Investigator
affiliation: Pacific Eye and Laser Institute
last name: Edgar U. Leuenberger, MD
role: Principal Investigator
affiliation: Asian Eye Institute
last name: Maria I Yap-Veloso, MD
role: Principal Investigator
affiliation: Asian Eye Institute
facility: 
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension