<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/NCT02992535</url>
  </required_header>
  <id_info>
    <org_study_id>TLEUROPE1</org_study_id>
    <nct_id>NCT02992535</nct_id>
  </id_info>
  <brief_title>Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity</brief_title>
  <official_title>Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carones Ophthalmology Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carones Ophthalmology Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment&#xD;
      with IPL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective study design among subjects with MGD and qualifying for IPL therapy.&#xD;
&#xD;
      Study testing done at baseline visit when subjects are scheduled for IPL therapy.&#xD;
      Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL&#xD;
      setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).&#xD;
&#xD;
      Subjects willing to come for follow up visits as scheduled and may not have instilled any&#xD;
      artificial tears 2 hours prior to study measurements.&#xD;
&#xD;
      No history of ocular infection or corneal degeneration/dystrophy No history of corneal&#xD;
      refractive surgery and/or change in ocular medications in the last 2 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear film osmolarity change</measure>
    <time_frame>Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense pulse light therapy (E-Schwin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Pulse Light Energy delivery (IPL)</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dry eye&#xD;
&#xD;
          -  MGD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No history of ocular infection or corneal degeneration/dystrophy&#xD;
&#xD;
          -  No history of corneal refractive surgery&#xD;
&#xD;
          -  No change in ocular medications in the last 2 months&#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_contact>
    <last_name>Francesco Carones, MD</last_name>
    <phone>+390276318174</phone>
    <email>fcarones@carones.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02992535
org study id: TLEUROPE1
nct id: NCT02992535
lead sponsor: 
has dmc: No
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment
      with IPL.
Prospective study design among subjects with MGD and qualifying for IPL therapy.

      Study testing done at baseline visit when subjects are scheduled for IPL therapy.
      Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL
      setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).

      Subjects willing to come for follow up visits as scheduled and may not have instilled any
      artificial tears 2 hours prior to study measurements.

      No history of ocular infection or corneal degeneration/dystrophy No history of corneal
      refractive surgery and/or change in ocular medications in the last 2 months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tear film osmolarity change
time frame: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
arm group label: Single arm
arm group type: Experimental
description: Intense pulse light therapy (E-Schwin)
intervention type: Device
intervention name: Intense Pulse Light Energy delivery (IPL)
arm group label: Single arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Francesco Carones, MD
phone: +390276318174
email: fcarones@carones.com
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: Undecided