<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/NCT04418999</url>
  </required_header>
  <id_info>
    <org_study_id>19027</org_study_id>
    <nct_id>NCT04418999</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus</brief_title>
  <official_title>Safety and Efficacy of Intracanalicular Dexamethasone Insert Compared to Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Illinois College of Optometry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Illinois College of Optometry</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>
      Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow&#xD;
      patients to eliminate topical medications which are generally associated with lack of&#xD;
      compliance, difficulty of use and requiring help from family members. These delivery systems&#xD;
      can be applied easily in office, and patients do not have to worry about drop insertion in&#xD;
      their post-operative regimen.&#xD;
&#xD;
      The results of this research project should help to answer the following question: Does the&#xD;
      use of a physician administered intracanalicular dexamethasone insert improve the signs and&#xD;
      symptoms of ocular allergy and dry eye disease in KC patients compared to the use of topical&#xD;
      loteprednol etabonate ophthalmic gel 0.38%?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have allergies</measure>
    <time_frame>90 days</time_frame>
    <description>For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, IOP will be taken at each visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have dry eye</measure>
    <time_frame>90 days</time_frame>
    <description>For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Keratoconus</condition>
  <condition>Dry Eye</condition>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>Dexamethasone insert</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loteprednol etabonate ophthalmic gel 0.38%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use</intervention_name>
    <description>Experimental</description>
    <arm_group_label>Dexamethasone insert</arm_group_label>
    <other_name>Dextenza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly</intervention_name>
    <description>Active Comparator</description>
    <arm_group_label>Loteprednol etabonate ophthalmic gel 0.38%</arm_group_label>
    <other_name>Lotemax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Bilateral Keratoconus&#xD;
&#xD;
          -  Bilateral RGP contact lenses&#xD;
&#xD;
          -  Bilateral allergic conjunctivitis as determined by the Papillae Efron Scale score of&#xD;
             at least 1 and symptoms of itching&#xD;
&#xD;
          -  Bilateral underlying dry eye disease as determined by the NEI Fluorescein Staining&#xD;
             Scale score of at least 1 and a TBUT of less than 10 and must correlate with dryness&#xD;
             on OSDI&#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 Patients with&#xD;
             severe disease that warrants critical attention, deemed unsafe for the study by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Illinois Eye Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 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>Keratoconus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 1, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04418999
org study id: 19027
nct id: NCT04418999
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow
      patients to eliminate topical medications which are generally associated with lack of
      compliance, difficulty of use and requiring help from family members. These delivery systems
      can be applied easily in office, and patients do not have to worry about drop insertion in
      their post-operative regimen.

      The results of this research project should help to answer the following question: Does the
      use of a physician administered intracanalicular dexamethasone insert improve the signs and
      symptoms of ocular allergy and dry eye disease in KC patients compared to the use of topical
      loteprednol etabonate ophthalmic gel 0.38%?
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have allergies
time frame: 90 days
description: For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, IOP will be taken at each visit
measure: To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have dry eye
time frame: 90 days
description: For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit
arm group label: Dexamethasone insert
arm group type: Experimental
description: Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum.
arm group label: Loteprednol etabonate ophthalmic gel 0.38%
arm group type: Active Comparator
description: Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper
intervention type: Drug
intervention name: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
description: Experimental
arm group label: Dexamethasone insert
other name: Dextenza
intervention type: Drug
intervention name: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
description: Active Comparator
arm group label: Loteprednol etabonate ophthalmic gel 0.38%
other name: Lotemax
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Loteprednol Etabonate
mesh term: Dexamethasone
sharing ipd: No
submitted: August 1, 2023