<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/NCT04465864</url>
  </required_header>
  <id_info>
    <org_study_id>DEXTENZA</org_study_id>
    <nct_id>NCT04465864</nct_id>
  </id_info>
  <brief_title>Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert</brief_title>
  <official_title>Randomized, Controlled Treatment With an Intracanalicular Dexamethasone (0.4mg) Insert Following Cataract Surgery With IOL Combined With MIGS, Specifically iStent, iStent Inject or KDB in Patients With POAG or Ocular Hypertension (OHTN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolstan and Goldberg Eye Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolstan and Goldberg Eye Associates</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert&#xD;
      following cataract surgery with intraocular lens implant (IOL) combined with minimally&#xD;
      invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with&#xD;
      primary open angle glaucoma (POAG) or ocular hypertension (OHTN)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine treatment and patient reported outcomes, following cataract surgery with&#xD;
      intraocular lens implant in conjunction with minimally invasive glaucoma surgery (MIGS) more&#xD;
      specifically iStent, iStent inject or KDB with an intracanalicular dexamethasone (0.4 mg)&#xD;
      insert, inserted four days (+/- 1 day) prior to surgery as compared to insertion on day of&#xD;
      surgery. Patients with either primary open angle glaucoma (POAG) or ocular hypertension&#xD;
      (OHTN) requiring cataract surgery with IOL implant, will be separated into two groups.&#xD;
&#xD;
      Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to&#xD;
      cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB)&#xD;
      insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular&#xD;
      dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL)&#xD;
      implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three&#xD;
      days prior to surgery)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>
    <intervention_model_description>Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)&#xD;
Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery</measure>
    <time_frame>four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.</time_frame>
    <description>Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 &amp; 45-day phone call.&#xD;
Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.</measure>
    <time_frame>insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.</time_frame>
    <description>Secondary: Will receive the insert on the day of surgery. Each enrolled study subject will be required to complete six scheduled visits over the course of the study period: Screening visit, operative/insertion visit, Day 1, 7, 30, and a 14 &amp; 45 day phone call.&#xD;
Measuring cell, pain and flare at (Day 1,30) Absence of cell to be defined as a grade of (0-0.5) Absence of flare to be defined as a grade of (0-1) Determining if call backs have decreased at the clinic with study patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Glaucoma, Primary Open Angle</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Insertion visit 4 days prior</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical 1 visit day 0</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intracanalicular Dexamethasone, 0.4 mg insert</intervention_name>
    <description>Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.</description>
    <arm_group_label>Insertion visit 4 days prior</arm_group_label>
    <arm_group_label>Surgical 1 visit day 0</arm_group_label>
    <other_name>MIGS (iStent, iStent inject or KDB) insertion.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Been diagnosed with POAG or OHTN and MIGS (iStent, iStent inject or KDB) has been&#xD;
             planned&#xD;
&#xD;
          -  Unilateral or bilateral cataract surgery with IOL has been planned&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study related procedures&#xD;
&#xD;
          -  Willing and able to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18.&#xD;
&#xD;
          -  Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)&#xD;
&#xD;
          -  Active infectious systemic disease&#xD;
&#xD;
          -  Active infectious ocular or extraocular disease&#xD;
&#xD;
          -  Unobstructed nasolacrimal duct in the study eye(s)&#xD;
&#xD;
          -  Hypersensitivity to dexamethasone&#xD;
&#xD;
          -  Patients being treated with immunomodulating agents in the study eye(s)&#xD;
&#xD;
          -  History of prior ocular surgery, including Lasik or PRK&#xD;
&#xD;
          -  History of ocular inflammation or macular edema&#xD;
&#xD;
          -  Patients being treated with &gt;375mg daily of NSAIDs&#xD;
&#xD;
             o Patients on doses higher than 375mg of oral NSAIDs will be considered if they&#xD;
             discontinue the medication 2 weeks prior to the study start date.&#xD;
&#xD;
          -  Patients taking inconsistent varying doses of an NSAID on a daily basis.&#xD;
&#xD;
          -  Patients being treated with immunosuppressants and/or oral steroids&#xD;
&#xD;
          -  Patients with a corticosteroid implant (i.e. Ozurdex)&#xD;
&#xD;
          -  Patients with severe disease that warrants critical attention, deemed unsafe for the&#xD;
             study by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damien Goldberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolstan &amp; Goldberg Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wolstan and Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>February 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 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>Cataract</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_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/NCT04465864
org study id: DEXTENZA
nct id: NCT04465864
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert
      following cataract surgery with intraocular lens implant (IOL) combined with minimally
      invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with
      primary open angle glaucoma (POAG) or ocular hypertension (OHTN)
To determine treatment and patient reported outcomes, following cataract surgery with
      intraocular lens implant in conjunction with minimally invasive glaucoma surgery (MIGS) more
      specifically iStent, iStent inject or KDB with an intracanalicular dexamethasone (0.4 mg)
      insert, inserted four days (+/- 1 day) prior to surgery as compared to insertion on day of
      surgery. Patients with either primary open angle glaucoma (POAG) or ocular hypertension
      (OHTN) requiring cataract surgery with IOL implant, will be separated into two groups.

      Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to
      cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB)
      insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular
      dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL)
      implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three
      days prior to surgery)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
primary purpose: Treatment
masking: Single (Participant)
measure: Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery
time frame: four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.
description: Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 & 45-day phone call.
Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)
measure: Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.
time frame: insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.
description: Secondary: Will receive the insert on the day of surgery. Each enrolled study subject will be required to complete six scheduled visits over the course of the study period: Screening visit, operative/insertion visit, Day 1, 7, 30, and a 14 & 45 day phone call.
Measuring cell, pain and flare at (Day 1,30) Absence of cell to be defined as a grade of (0-0.5) Absence of flare to be defined as a grade of (0-1) Determining if call backs have decreased at the clinic with study patients
arm group label: Insertion visit 4 days prior
arm group type: Other
description: Intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
arm group label: Surgical 1 visit day 0
arm group type: Other
description: Intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
intervention type: Drug
intervention name: Intracanalicular Dexamethasone, 0.4 mg insert
description: Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.
arm group label: Insertion visit 4 days prior
arm group label: Surgical 1 visit day 0
other name: MIGS (iStent, iStent inject or KDB) insertion.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Damien Goldberg, MD
role: Principal Investigator
affiliation: Wolstan & Goldberg Eye Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Glaucoma, Open-Angle
mesh term: Dexamethasone
sharing ipd: No