<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/NCT04464629</url>
  </required_header>
  <id_info>
    <org_study_id>The FINNEN Study</org_study_id>
    <nct_id>NCT04464629</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment</brief_title>
  <official_title>Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Midwest Eye Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ocular Therapeutix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Midwest Eye Institute</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, open-label, single-center, randomized, investigator-sponsored clinical&#xD;
      study seeks to investigate: how will pseudophakic patients respond in terms of objective and&#xD;
      subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate&#xD;
      following gas bubble repair and laser for RD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who have given informed consent and determined to be eligible at screening will be&#xD;
      randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of&#xD;
      topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period&#xD;
      of 3-months for both pain and inflammation of the eye.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">January 25, 2023</completion_date>
  <primary_completion_date type="Actual">January 25, 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in pain score</measure>
    <time_frame>30 Days</time_frame>
    <description>Average change in pain based on whats reported on the Ocular Pain Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-op pain scores</measure>
    <time_frame>30 Days</time_frame>
    <description>Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in anterior chamber cell and flare score</measure>
    <time_frame>30 days</time_frame>
    <description>Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cystoid Macular Edema</measure>
    <time_frame>30 days</time_frame>
    <description>Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual Acuity</measure>
    <time_frame>90 days</time_frame>
    <description>As measured on ETDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Ease of Dextenza insertion</measure>
    <time_frame>Day 1</time_frame>
    <description>The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Retinal Detachment</condition>
  <arm_group>
    <arm_group_label>Intracanalicular Sustained Release Dexamethasone, 0.4 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical prednisolone acetate 1%.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextenza</intervention_name>
    <description>Intracanalicular sustained release dexamethasone insert 0.4 mg</description>
    <arm_group_label>Intracanalicular Sustained Release Dexamethasone, 0.4 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone Acetate</intervention_name>
    <description>Topical Prednisolone acetate 1% ophthalmic suspension</description>
    <arm_group_label>topical prednisolone acetate 1%.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pseudophakic&#xD;
&#xD;
          -  Retinal Detachment&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Scheduled for gas bubble repair and laser surgery following retinal detachment&#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;
          -  Obstructed 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;
          -  Patients being treated with immunosuppressants and/or oral 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>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Finnen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Medical Advisors, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Midwest Eye Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Midwest Eye Institute</investigator_affiliation>
    <investigator_full_name>Neil Finnen, MD</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>Retinal Detachment</mesh_term>
    <mesh_term>Dissociative Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</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/NCT04464629
org study id: The FINNEN Study
nct id: NCT04464629
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This prospective, open-label, single-center, randomized, investigator-sponsored clinical
      study seeks to investigate: how will pseudophakic patients respond in terms of objective and
      subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate
      following gas bubble repair and laser for RD.
Subjects who have given informed consent and determined to be eligible at screening will be
      randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of
      topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period
      of 3-months for both pain and inflammation of the eye.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mean change in pain score
time frame: 30 Days
description: Average change in pain based on whats reported on the Ocular Pain Assessment
measure: Post-op pain scores
time frame: 30 Days
description: Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
measure: Mean change in anterior chamber cell and flare score
time frame: 30 days
description: Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.
measure: Cystoid Macular Edema
time frame: 30 days
description: Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)
measure: Best Corrected Visual Acuity
time frame: 90 days
description: As measured on ETDRS
measure: Physician Ease of Dextenza insertion
time frame: Day 1
description: The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.
arm group label: Intracanalicular Sustained Release Dexamethasone, 0.4 mg
arm group type: Experimental
description: Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.
arm group label: topical prednisolone acetate 1%.
arm group type: Active Comparator
intervention type: Drug
intervention name: Dextenza
description: Intracanalicular sustained release dexamethasone insert 0.4 mg
arm group label: Intracanalicular Sustained Release Dexamethasone, 0.4 mg
intervention type: Drug
intervention name: Prednisolone Acetate
description: Topical Prednisolone acetate 1% ophthalmic suspension
arm group label: topical prednisolone acetate 1%.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Finnen, MD
role: Principal Investigator
affiliation: Midwest Medical Advisors, Inc
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Midwest Eye Institute
investigator full name: Neil Finnen, MD
investigator title: Principal Investigator
mesh term: Retinal Detachment
mesh term: Dissociative Disorders
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No