<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/NCT04413253</url>
  </required_header>
  <id_info>
    <org_study_id>The DAMON Study</org_study_id>
    <nct_id>NCT04413253</nct_id>
  </id_info>
  <brief_title>Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease</brief_title>
  <official_title>Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone</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 patients with dry eye who are beginning treatment with Xiidra&#xD;
      (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes&#xD;
      will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA®&#xD;
      insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned&#xD;
      to receive sham punctum dilation (control eye). If there is no obvious symptomatic&#xD;
      difference, the right eye will receive the intracanalicular insert. The study group will&#xD;
      consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes&#xD;
      receiving sham punctum dilation. Thus, for every eye in the study group, there will be a&#xD;
      paired eye with similar baseline characteristics in the control group sourced from the same&#xD;
      participant. This fellow-eye design allows for greater control of potential confounders tied&#xD;
      to participants' systemic and ocular health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">April 11, 2022</completion_date>
  <primary_completion_date type="Actual">April 11, 2022</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>Mean change in ocular surface staining</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by sodium fluorescein and lissamine green</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Preference for therapy</measure>
    <time_frame>Assessed at Week 12 Visit</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 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measure by InflammaDry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in tear break-up time (TBUT)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by TBUT testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in conjunctival injection</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured on a scale of 0-4 and graded by the physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in meibomian gland scores (expressibility and quality)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured on a grading scale 1 to 4 and graded by the physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in tear osmolarity</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by Tear Lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in DEQ-5</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measured by the DEQ-5 Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Best-corrected Visual Acuity (BCVA)</measure>
    <time_frame>Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit</time_frame>
    <description>As measure by ETDRS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>Xiidra Only Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with dry eye disease Xiidra only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xiidra + Dextenza Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with dry eye disease Xiidra + Dextenza</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lifitegrast 5% Ophthalmic Solution</intervention_name>
    <description>To reduce signs and symptoms of dry eye disease</description>
    <arm_group_label>Xiidra Only Group</arm_group_label>
    <other_name>Xiidra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution</intervention_name>
    <description>To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.</description>
    <arm_group_label>Xiidra + Dextenza Group</arm_group_label>
    <other_name>Dextenza</other_name>
    <other_name>Xiidra</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;
          -  Signs and symptoms of DED&#xD;
&#xD;
          -  Consent to treat with topical immunomodulator&#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;
          -  Patients who have been on topical immunomodulating agents in the previous 3 months to&#xD;
             their baseline visit&#xD;
&#xD;
          -  Patient being treated with either topical, oral, or intravenous immunosuppressive&#xD;
             agents, immunomodulating agents, or steroid (including NSAIDS)&#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>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Lifitegrast</mesh_term>
    <mesh_term>Ophthalmic Solutions</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/NCT04413253
org study id: The DAMON Study
nct id: NCT04413253
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 patients with dry eye who are beginning treatment with Xiidra
      (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes
      will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA®
      insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned
      to receive sham punctum dilation (control eye). If there is no obvious symptomatic
      difference, the right eye will receive the intracanalicular insert. The study group will
      consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes
      receiving sham punctum dilation. Thus, for every eye in the study group, there will be a
      paired eye with similar baseline characteristics in the control group sourced from the same
      participant. This fellow-eye design allows for greater control of potential confounders tied
      to participants' systemic and ocular health.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean change in ocular surface staining
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured by sodium fluorescein and lissamine green
measure: Patient Preference for therapy
time frame: Assessed at Week 12 Visit
description: As measured by COMTOL Survey
measure: Mean change in MMP-9
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measure by InflammaDry
measure: Mean change in tear break-up time (TBUT)
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured by TBUT testing
measure: Mean change in conjunctival injection
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured on a scale of 0-4 and graded by the physician
measure: Change from baseline in meibomian gland scores (expressibility and quality)
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured on a grading scale 1 to 4 and graded by the physician
measure: Mean change in tear osmolarity
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured by Tear Lab
measure: Mean change in DEQ-5
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measured by the DEQ-5 Questionnaire
measure: Mean change in Best-corrected Visual Acuity (BCVA)
time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
description: As measure by ETDRS
arm group label: Xiidra Only Group
arm group type: Active Comparator
description: Patients with dry eye disease Xiidra only
arm group label: Xiidra + Dextenza Group
arm group type: Experimental
description: Patients with dry eye disease Xiidra + Dextenza
intervention type: Drug
intervention name: Lifitegrast 5% Ophthalmic Solution
description: To reduce signs and symptoms of dry eye disease
arm group label: Xiidra Only Group
other name: Xiidra
intervention type: Drug
intervention name: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
description: To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
arm group label: Xiidra + Dextenza Group
other name: Dextenza
other name: Xiidra
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
mesh term: Pharmaceutical Solutions
mesh term: Lifitegrast
mesh term: Ophthalmic Solutions