<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/NCT04479748</url>
  </required_header>
  <id_info>
    <org_study_id>DEXTENZA</org_study_id>
    <nct_id>NCT04479748</nct_id>
  </id_info>
  <brief_title>DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses</brief_title>
  <official_title>DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prism Vision Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prism Vision Group</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators seek to assess the effect of pre-operative and continued post-operative&#xD;
      corticosteroid use on pain, patient preference, visual outcomes, and change in objective&#xD;
      quantifiable biological parameters in patients undergoing bilateral cataract surgery with&#xD;
      premium intraocular lens implantation with or without baseline ocular surface disease.&#xD;
&#xD;
      Patient's first eye scheduled for surgery will receive an intracanalicular insertion of&#xD;
      DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The&#xD;
      fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID,&#xD;
      QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in&#xD;
      patient baseline demographic and systemic characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">December 12, 2022</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scale</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30.&#xD;
Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Dextenza insert</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fellow-eye</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Treatment of pain and inflammation following ophthalmic surgery</description>
    <arm_group_label>Dextenza insert</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone Acetate 1% Oph Susp</intervention_name>
    <description>Topical steroid</description>
    <arm_group_label>Fellow-eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age 18 or greater with plans to undergo bilateral clear cornea cataract surgery with&#xD;
             phacoemulsification and implantation of a premium posterior chamber IOL&#xD;
&#xD;
               -  Schirmer's test score (anesthetized) ≥ 5 mm at Screening in either eye.&#xD;
&#xD;
               -  TBUT ≤ 7 seconds at Screening or Baseline in either eye.&#xD;
&#xD;
               -  All subjects must provide signed written consent prior to participation in any&#xD;
                  study-related procedures. Able to comply with study requirements and visit&#xD;
                  schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  revious corneal surgery or pathology&#xD;
&#xD;
               -  Active or history of chronic or recurrent inflammatory eye disease in either eye&#xD;
&#xD;
               -  Ocular pain in either eye&#xD;
&#xD;
               -  Proliferative diabetic retinopathy in either eye&#xD;
&#xD;
               -  Significant macular pathology detected on macular optical coherence tomography&#xD;
                  evaluation at the screening visit in either eye&#xD;
&#xD;
               -  Laser or incisional ocular surgery during the study period and 6 months prior in&#xD;
                  either eye&#xD;
&#xD;
               -  Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within&#xD;
                  21 days prior to Screening and throughout the study period (systemic mast cell&#xD;
                  stabilizers are allowed, and systemic antihistamines are permitted)&#xD;
&#xD;
               -  Chronic daily use (defined as &gt; 7 consecutive days at the recommended dosing&#xD;
                  frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia,&#xD;
                  rheumatoid arthritis, etc.) during the study period.&#xD;
&#xD;
               -  Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any&#xD;
                  OTC artificial tear (preserved or unpreserved) should be continued at the same&#xD;
                  frequency and with no change in drop brand.&#xD;
&#xD;
               -  Use of any topical prescription ophthalmic medications (including cyclosporine&#xD;
                  [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal&#xD;
                  anti- inflammatory drugs [NSAIDs], anti-glaucoma medications within 7 days or&#xD;
                  during study period&#xD;
&#xD;
               -  Participation in any drug or device clinical investigation within 30 days prior&#xD;
                  to entry into this study and/or during the period of study participation.&#xD;
&#xD;
               -  Corticosteroids (intranasal, inhaled, topical dermatological, and perianal&#xD;
                  steroids) within 30 days prior to entry in the study are not permitted&#xD;
&#xD;
               -  Pregnant or breast-feeding women, women who wish to become pregnant during the&#xD;
                  length of study participation, or women of child-bearing potential.&#xD;
&#xD;
               -  Use of systemic NSAID greater than 375 mg per day.&#xD;
&#xD;
               -  Glaucoma or is on medications to treat glaucoma.&#xD;
&#xD;
               -  Ocular Hypertension, defined as IOP of &gt;21 mmHg, is on medications to treat&#xD;
                  hypertension or has a history of IOP spikes in either eye including&#xD;
                  steroid-related IOP increases.&#xD;
&#xD;
               -  Presence of nasolacrimal duct obstruction or history of cauterization of the&#xD;
                  Punctum.&#xD;
&#xD;
               -  Active epiphora or clinically significant dry eye syndrome.&#xD;
&#xD;
               -  Know allergy or sensitivity to the investigational product or its components.&#xD;
&#xD;
               -  The Investigator determines that the subject should not be included for reasons&#xD;
                  not already specified (e.g, systemic or other ocular disease/abnormality) if the&#xD;
                  health of the subject or the validity of the study outcomes may be compromised by&#xD;
                  the subject's enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eye Associates of Vineland</name>
      <address>
        <city>Vineland</city>
        <state>New Jersey</state>
        <zip>08361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prism Vision Group</investigator_affiliation>
    <investigator_full_name>Dr. Sydney Tyson</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>Cataract</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>
  <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/NCT04479748
org study id: DEXTENZA
nct id: NCT04479748
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators seek to assess the effect of pre-operative and continued post-operative
      corticosteroid use on pain, patient preference, visual outcomes, and change in objective
      quantifiable biological parameters in patients undergoing bilateral cataract surgery with
      premium intraocular lens implantation with or without baseline ocular surface disease.

      Patient's first eye scheduled for surgery will receive an intracanalicular insertion of
      DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The
      fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID,
      QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in
      patient baseline demographic and systemic characteristics.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Scale
time frame: 30 days
description: Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30.
Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.
arm group label: Dextenza insert
arm group type: Other
description: Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye).
arm group label: Fellow-eye
arm group type: Other
description: The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.
intervention type: Drug
intervention name: Dexamethasone
description: Treatment of pain and inflammation following ophthalmic surgery
arm group label: Dextenza insert
intervention type: Drug
intervention name: Prednisolone Acetate 1% Oph Susp
description: Topical steroid
arm group label: Fellow-eye
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Prism Vision Group
investigator full name: Dr. Sydney Tyson
investigator title: Principal Investigator
mesh term: Cataract
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
sharing ipd: No