<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/NCT04403516</url>
  </required_header>
  <id_info>
    <org_study_id>Dextenza in Pterygium Surgery</org_study_id>
    <nct_id>NCT04403516</nct_id>
  </id_info>
  <brief_title>Dextenza in Pterygium Surgery</brief_title>
  <official_title>Dextenza in Pterygium Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michelle Rhee MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ocular Therapeutix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>New York Eye Specialists</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>
      DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of&#xD;
      care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of&#xD;
      pterygium with conjunctival autograft)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive&#xD;
      either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion&#xD;
      into both the upper and lower puncta at the time of surgery, followed by at postoperative&#xD;
      month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks&#xD;
      then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone&#xD;
      acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks&#xD;
      then discontinued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">August 5, 2021</completion_date>
  <primary_completion_date type="Actual">August 5, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction-comfort and convenience</measure>
    <time_frame>Assessed on Post-Op Day 1</time_frame>
    <description>Assessed by patient reported questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction-comfort and convenience</measure>
    <time_frame>Assessed on Week 1</time_frame>
    <description>Assessed by patient reported questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction-comfort and convenience</measure>
    <time_frame>Assessed on Month 1</time_frame>
    <description>Assessed by patient reported questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction-comfort and convenience</measure>
    <time_frame>Assessed on Month 3</time_frame>
    <description>Assessed by patient reported questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction-comfort and convenience</measure>
    <time_frame>Assessed on Month 6</time_frame>
    <description>Assessed by patient reported questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the degree of conjunctival hyperemia</measure>
    <time_frame>Assessed on Week 1</time_frame>
    <description>Assessed by clinical external photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the degree of conjunctival hyperemia</measure>
    <time_frame>Assessed on Month 1</time_frame>
    <description>Assessed by clinical external photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the degree of conjunctival hyperemia</measure>
    <time_frame>Assessed on Month 2</time_frame>
    <description>Assessed by clinical external photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the degree of conjunctival hyperemia</measure>
    <time_frame>Assessed on Month 3</time_frame>
    <description>Assessed by clinical external photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the degree of conjunctival hyperemia</measure>
    <time_frame>Assessed on Month 6</time_frame>
    <description>Assessed by clinical external photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days for corneal re-epithelialization</measure>
    <time_frame>Assessed on Post-Op Day 1</time_frame>
    <description>As evaluated by slit lamp examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days for corneal re-epithelialization</measure>
    <time_frame>Assessed on Week 1</time_frame>
    <description>As evaluated by slit lamp examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days for corneal re-epithelialization</measure>
    <time_frame>Assessed on Month 1</time_frame>
    <description>As evaluated by slit lamp examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of pterygium</measure>
    <time_frame>Assessed at Month 1</time_frame>
    <description>As measured by yes or no on recurrence; external eye examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of pterygium</measure>
    <time_frame>Assessed at Month 2</time_frame>
    <description>As measured by yes or no on recurrence; external eye examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of pterygium</measure>
    <time_frame>Assessed at Month 3</time_frame>
    <description>As measured by yes or no on recurrence; external eye examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of pterygium</measure>
    <time_frame>Assessed at Month 6</time_frame>
    <description>As measured by yes or no on recurrence; external eye examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pterygium</condition>
  <arm_group>
    <arm_group_label>DEXTENZA Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Pterygium DEXTENZA Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical Prednisolone Acetate 1% Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Pterygium Topical Prednisolone Acetate 1% Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Intracanalicular Insert, 0.4mg</intervention_name>
    <description>To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.</description>
    <arm_group_label>DEXTENZA Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone Acetate 1%</intervention_name>
    <description>To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.</description>
    <arm_group_label>Topical Prednisolone Acetate 1% Group</arm_group_label>
  </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;
        • Age of at least 18 years with primary pterygia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient who meets any of the following criteria will be excluded from the study:&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Ocular hypertension&#xD;
&#xD;
          -  Prior conjunctival surgery&#xD;
&#xD;
          -  Other uncontrolled ocular disease&#xD;
&#xD;
          -  Ocular surgery in either eye within 3 months&#xD;
&#xD;
          -  Use of eye drops other than postoperative medications and artificial tears&#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>Michelle K Rhee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Eye Specialists</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Eye Specialists</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</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 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>New York Eye Specialists</investigator_affiliation>
    <investigator_full_name>Michelle Rhee 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>Pterygium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <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>
  <!-- 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/NCT04403516
org study id: Dextenza in Pterygium Surgery
nct id: NCT04403516
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of
      care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of
      pterygium with conjunctival autograft)
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive
      either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion
      into both the upper and lower puncta at the time of surgery, followed by at postoperative
      month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks
      then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone
      acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks
      then discontinued.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA (15 eyes) into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued or receive topical prednisolone acetate 1% (15 eyes) q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.
primary purpose: Treatment
masking: None (Open Label)
measure: Patient satisfaction-comfort and convenience
time frame: Assessed on Post-Op Day 1
description: Assessed by patient reported questionnaire
measure: Patient satisfaction-comfort and convenience
time frame: Assessed on Week 1
description: Assessed by patient reported questionnaire
measure: Patient satisfaction-comfort and convenience
time frame: Assessed on Month 1
description: Assessed by patient reported questionnaire
measure: Patient satisfaction-comfort and convenience
time frame: Assessed on Month 3
description: Assessed by patient reported questionnaire
measure: Patient satisfaction-comfort and convenience
time frame: Assessed on Month 6
description: Assessed by patient reported questionnaire
measure: To compare the degree of conjunctival hyperemia
time frame: Assessed on Week 1
description: Assessed by clinical external photography
measure: To compare the degree of conjunctival hyperemia
time frame: Assessed on Month 1
description: Assessed by clinical external photography
measure: To compare the degree of conjunctival hyperemia
time frame: Assessed on Month 2
description: Assessed by clinical external photography
measure: To compare the degree of conjunctival hyperemia
time frame: Assessed on Month 3
description: Assessed by clinical external photography
measure: To compare the degree of conjunctival hyperemia
time frame: Assessed on Month 6
description: Assessed by clinical external photography
measure: Mean number of days for corneal re-epithelialization
time frame: Assessed on Post-Op Day 1
description: As evaluated by slit lamp examination
measure: Mean number of days for corneal re-epithelialization
time frame: Assessed on Week 1
description: As evaluated by slit lamp examination
measure: Mean number of days for corneal re-epithelialization
time frame: Assessed on Month 1
description: As evaluated by slit lamp examination
measure: Recurrence of pterygium
time frame: Assessed at Month 1
description: As measured by yes or no on recurrence; external eye examination
measure: Recurrence of pterygium
time frame: Assessed at Month 2
description: As measured by yes or no on recurrence; external eye examination
measure: Recurrence of pterygium
time frame: Assessed at Month 3
description: As measured by yes or no on recurrence; external eye examination
measure: Recurrence of pterygium
time frame: Assessed at Month 6
description: As measured by yes or no on recurrence; external eye examination
arm group label: DEXTENZA Group
arm group type: Experimental
description: Patients with Pterygium DEXTENZA Group
arm group label: Topical Prednisolone Acetate 1% Group
arm group type: Experimental
description: Patients with Pterygium Topical Prednisolone Acetate 1% Group
intervention type: Drug
intervention name: Dexamethasone Intracanalicular Insert, 0.4mg
description: To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
arm group label: DEXTENZA Group
intervention type: Drug
intervention name: Prednisolone Acetate 1%
description: To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
arm group label: Topical Prednisolone Acetate 1% Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle K Rhee, MD
role: Principal Investigator
affiliation: New York Eye Specialists
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: New York Eye Specialists
investigator full name: Michelle Rhee MD
investigator title: Principal Investigator
mesh term: Pterygium
mesh term: Dexamethasone
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