<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/NCT04413279</url>
  </required_header>
  <id_info>
    <org_study_id>The DIERKER Study</org_study_id>
    <nct_id>NCT04413279</nct_id>
  </id_info>
  <brief_title>Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease</brief_title>
  <official_title>Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye Surgeons of Indiana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ocular Therapeutix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eye Surgeons of Indiana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the benefit of treatment with a physician administered intracanalicular&#xD;
      dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland&#xD;
      disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical&#xD;
      study seeks to investigate the benefit of managing patients with DED secondary to MGD with a&#xD;
      sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow&#xD;
      Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will&#xD;
      evaluate the ease of Dextenza insertion and the patient preference for therapy.&#xD;
&#xD;
      After screening a given patient for inclusion and exclusion criteria, and gaining informed&#xD;
      consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most&#xD;
      symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure&#xD;
      (study eye), while the other eye will be assigned to a receive a sham punctum dilation&#xD;
      (control eye). If there is no obvious symptomatic difference, the right eye will receive the&#xD;
      intracanalicular insert. Per patient, the study period will last for approximately 12 weeks&#xD;
      after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3&#xD;
      post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12,&#xD;
      primary and secondary endpoints will be assessed alongside standard-of-care procedures.&#xD;
      Adjusting for enrollment period, the study will last a total of approximately 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in meibomian gland scores (expressibility and quality)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12</time_frame>
    <description>As measured on a grading scale 1 to 4 and graded by the physician</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient preference for</measure>
    <time_frame>Assessed at Week 12</time_frame>
    <description>As measured by COMTOL Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in MMP-9</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by InflammaDry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in ocular surface staining</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by sodium fluorescein and lissamine green</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in tear break-up time (TBUT)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by TBUT testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in tear osmolarity</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by TearLab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in DEQ-5</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Best-corrected Visual Acuity (BCVA)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by ETDRS chart</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>Lipiflow Only Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with dry eye disease Lipiflow only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipiflow + Dextenza Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with dry eye disease Lipiflow + Dextenza</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LipiFlow Thermal Pulsation</intervention_name>
    <description>To manage patients with dry eye disease secondary to MGD</description>
    <arm_group_label>Lipiflow Only Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation</intervention_name>
    <description>to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation</description>
    <arm_group_label>Lipiflow + Dextenza Group</arm_group_label>
    <other_name>Dextenza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A patient's study eye must meet the following criteria to be eligible for inclusion in the&#xD;
        study:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Evaporative DED with MGD and clinically significant inflammation&#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;
        A patient who meets any of the following criteria will be excluded from the study:&#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;
          -  Altered nasolacrimal flow of either acquired, induced, or congenital origin&#xD;
&#xD;
          -  Hypersensitivity to dexamethasone&#xD;
&#xD;
          -  Patient being treated with either topical, oral, or intravenous steroids&#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>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damon Dierker, OD, FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eye Surgeons of Indiana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eye Surgeons of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT04413279
org study id: The DIERKER Study
nct id: NCT04413279
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the benefit of treatment with a physician administered intracanalicular
      dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland
      disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical
      study seeks to investigate the benefit of managing patients with DED secondary to MGD with a
      sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow
      Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will
      evaluate the ease of Dextenza insertion and the patient preference for therapy.

      After screening a given patient for inclusion and exclusion criteria, and gaining informed
      consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most
      symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure
      (study eye), while the other eye will be assigned to a receive a sham punctum dilation
      (control eye). If there is no obvious symptomatic difference, the right eye will receive the
      intracanalicular insert. Per patient, the study period will last for approximately 12 weeks
      after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3
      post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12,
      primary and secondary endpoints will be assessed alongside standard-of-care procedures.
      Adjusting for enrollment period, the study will last a total of approximately 4 months.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in meibomian gland scores (expressibility and quality)
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12
description: As measured on a grading scale 1 to 4 and graded by the physician
measure: Patient preference for
time frame: Assessed at Week 12
description: As measured by COMTOL Survey
measure: Mean change in MMP-9
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by InflammaDry
measure: Mean change in ocular surface staining
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by sodium fluorescein and lissamine green
measure: Mean change in tear break-up time (TBUT)
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by TBUT testing
measure: Mean change in tear osmolarity
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by TearLab
measure: Mean change in DEQ-5
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms.
measure: Mean change in Best-corrected Visual Acuity (BCVA)
time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
description: As measured by ETDRS chart
arm group label: Lipiflow Only Group
arm group type: Active Comparator
description: Patients with dry eye disease Lipiflow only
arm group label: Lipiflow + Dextenza Group
arm group type: Experimental
description: Patients with dry eye disease Lipiflow + Dextenza
intervention type: Procedure
intervention name: LipiFlow Thermal Pulsation
description: To manage patients with dry eye disease secondary to MGD
arm group label: Lipiflow Only Group
intervention type: Drug
intervention name: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation
description: to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation
arm group label: Lipiflow + Dextenza Group
other name: Dextenza
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Damon Dierker, OD, FAAO
role: Principal Investigator
affiliation: Eye Surgeons of Indiana
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Dexamethasone