<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/NCT03751059</url>
  </required_header>
  <id_info>
    <org_study_id>TWM</org_study_id>
    <nct_id>NCT03751059</nct_id>
  </id_info>
  <brief_title>NSAID vs Steroid in Trabeculectomy Wound Management</brief_title>
  <official_title>An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cindy Hutnik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glaucoma Research Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ivey Eye Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the efficacy of steroid vs NSAID treatment in relation to&#xD;
      trabeculectomy wound management. Eligible study participants will be randomized to receive&#xD;
      either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose&#xD;
      with their assigned study treatment until three months post-trabeculectomy. Study&#xD;
      participants will be followed for twelve months post-trabeculectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target IOP</measure>
    <time_frame>12 months</time_frame>
    <description>the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>NSAID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dexamethasone: used from one week post-op to three months post-op</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bromfenac 0.07% Oph Susp</intervention_name>
    <description>Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.</description>
    <arm_group_label>NSAID</arm_group_label>
    <other_name>Bromfenac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.</description>
    <arm_group_label>Steroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over the age of 18 years&#xD;
&#xD;
          -  Uncontrolled open angle glaucoma&#xD;
&#xD;
          -  Scheduled to undergo stand-alone trabeculectomy&#xD;
&#xD;
          -  No previous incisional glaucoma surgery&#xD;
&#xD;
          -  No ocular surgery of any kind in prior 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  steroids and/or NSAIDs contraindicated&#xD;
&#xD;
          -  poor corneal epithelial health&#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>Cindy Hutnik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ivey Eye Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Coordinator</last_name>
    <phone>519.646.6100</phone>
    <phone_ext>66272</phone_ext>
    <email>rboyd24@uwo.ca</email>
  </overall_contact>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ivey Eye Institute</investigator_affiliation>
    <investigator_full_name>Cindy Hutnik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bromfenac</mesh_term>
  </intervention_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/NCT03751059
org study id: TWM
nct id: NCT03751059
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will examine the efficacy of steroid vs NSAID treatment in relation to
      trabeculectomy wound management. Eligible study participants will be randomized to receive
      either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose
      with their assigned study treatment until three months post-trabeculectomy. Study
      participants will be followed for twelve months post-trabeculectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Target IOP
time frame: 12 months
description: the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
arm group label: NSAID
arm group type: Active Comparator
description: Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op
arm group label: Steroid
arm group type: Active Comparator
description: Dexamethasone: used from one week post-op to three months post-op
intervention type: Drug
intervention name: Bromfenac 0.07% Oph Susp
description: Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
arm group label: NSAID
other name: Bromfenac
intervention type: Drug
intervention name: Dexamethasone
description: Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.
arm group label: Steroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy Hutnik, MD
role: Principal Investigator
affiliation: Ivey Eye Institute
last name: Study Coordinator
phone: 519.646.6100
phone ext: 66272
email: rboyd24@uwo.ca
responsible party type: Sponsor-Investigator
investigator affiliation: Ivey Eye Institute
investigator full name: Cindy Hutnik
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Dexamethasone
mesh term: Bromfenac