<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/NCT03280069</url>
  </required_header>
  <id_info>
    <org_study_id>OCLI-RFE-10D</org_study_id>
    <nct_id>NCT03280069</nct_id>
  </id_info>
  <brief_title>Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region</brief_title>
  <official_title>Evaluation of Ocular Surface Changes Following RF Electrocoagulation Treatment of the Periorbital Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ophthalmic Consultants of Long Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ophthalmic Consultants of Long Island</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol will evaluate THERMIeyes® for its ability to treat periorbital skin laxity and&#xD;
      wrinkles and monitor ocular surface changes and their effect on evaporative dry eye&#xD;
      associated with MGD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with skin laxity and evaporative dry eye will be recruited for enrollment in this&#xD;
      study. Subjects must present with subjective and objective indicators for periorbital skin&#xD;
      laxity and wrinkle grade of 2 or greater out of a 4 point scale. To qualify, subjects must&#xD;
      present with high symptoms score on subjective Ocular Surface Disease Index© (OSDI©)&#xD;
      Questionnaires (scores≥ 15); Rapid Tear Break up (&lt; 5 seconds) and Grade ≥ 1 of Flourescein&#xD;
      Staining in one area of the cornea. Each of these parameters are to be assessed prior to&#xD;
      treatment and at each follow up visit. Treatment is to be performed on periorbital skin only&#xD;
      around one eye of the subject using the THERMIeyes® standard protocol. This may result in&#xD;
      some redness of the periorbital skin. Subjects are to be seen and treated 2-3 weeks apart for&#xD;
      a total of 3 treatments. Subjects will be followed at 6 and 12 weeks after the final&#xD;
      treatment. A Validated Grading Scale for Crow's Feet will be used to evaluate changes in skin&#xD;
      wrinkles and dry eye signs and symptoms scores will be compared with pre-treatment findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skin Laxity</measure>
    <time_frame>5 Months</time_frame>
    <description>Subjective and Objective improvement in skin laxity and wrinkles using the validation Grading Scale for Crow's Feet&#xD;
• To identify an improvement in the signs of dry eye defined as a decrease in total corneal staining after treatment compared with pre-treatment findings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface changes</measure>
    <time_frame>3 Months</time_frame>
    <description>Improvement in dry eye symptoms defined by a decrease in the OSDI score by 25% and decrease in total corneal staining</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Skin Laxity</condition>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>Subjects between the ages of 40 - 70</arm_group_label>
    <description>Subjects who present with signs of skin laxity &amp; evaporation dry eye will receive 3 treatments with the THERMIeyes® 20 RF System and monitored for improvements in the conditions for which they have presented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>THERMIeyes® 20 RF System</intervention_name>
    <description>The masked evaluating physician will be blinded as to which eye is treated. The evaluation on all visits will be performed on both eyes by the masked physician who will not know which eye has been treated with the THERMIeyes® 20 RF System. The treating technician will be aware of the treated eye so as to ensure all treatments are performed to the same eye.</description>
    <arm_group_label>Subjects between the ages of 40 - 70</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects presenting with a Crow Feet Grading score of 2 or greater for skin laxity around&#xD;
        their periorbital area and an OSDI score of 15 or greated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be 40-70 Inclusive; Male or Female&#xD;
&#xD;
          -  Subjects must demonstrate subjective and objective indicators for periorbital skin&#xD;
             laxity and wrinkle grade of 2 or greater out of a 4 point scale&#xD;
&#xD;
          -  Subjects must have an OSDI© score of ≥ 15,&#xD;
&#xD;
          -  Subjects must have a Grade 1 or higher staining pattern with fluorescein stain in any&#xD;
             area of the cornea.&#xD;
&#xD;
          -  The subjects may continue their current treatment for dry eye including the use of&#xD;
             artificial tears, gels or ointments. They are to continue any topical medications for&#xD;
             dry eye such as Cyclosporin or Lifitegrast. Subjects may continue to take chronic&#xD;
             medications systemically including anti-inflammatory medications (aspirin, NSAIDS,&#xD;
             Prednisone) as long as the dose and frequency is not changed throughout the study.&#xD;
&#xD;
          -  Subjects may be included if they have punctual plugs present in any tear duct. If a&#xD;
             plug comes out during the study it may be re-inserted so that the Subject is returned&#xD;
             to their pre-treatment baseline state.&#xD;
&#xD;
          -  Women of childbearing years should have pregnancy testing performed to ensure that&#xD;
             pregnancy has not occurred during the study. Urine pregnancy screening will be&#xD;
             performed prior to any treatment and on follow up visits until the study is completed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject must meet the inclusion criteria as listed&#xD;
&#xD;
          -  During the study they cannot have any new medications started that are&#xD;
             anti-inflammatory in nature. This includes topical steroids, Lifitegrast, cyclosporine&#xD;
             or systemic medications such as steroids, NSAIDS, aspirin, Doxycyline or other&#xD;
             Macrolid antibiotics.&#xD;
&#xD;
          -  Subjects cannot have a punctual plug inserted into a tear duct that has not had a plug&#xD;
             present prior to the start of the study.&#xD;
&#xD;
          -  Participation in other clinical trials during the course of this study is not&#xD;
             permitted.&#xD;
&#xD;
          -  Women who are pregnant or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard D'Aversa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophthalmic Consultants of Long Island</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carla DelCastillo</last_name>
    <phone>516-593-4026</phone>
    <email>cdelcastillo@ocli.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Long Island</name>
      <address>
        <city>Lynbrook</city>
        <state>New York</state>
        <zip>11563</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carla DelCastillo</last_name>
      <phone>516-593-4026</phone>
      <email>cdelcastillo@ocli.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ophthalmic Consultants of Long Island</investigator_affiliation>
    <investigator_full_name>Gerard D'Aversa, 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>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not be sharing individual participant data with other researchers but do plan to present the total findings of the study.</ipd_description>
  </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/NCT03280069
org study id: OCLI-RFE-10D
nct id: NCT03280069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This protocol will evaluate THERMIeyes® for its ability to treat periorbital skin laxity and
      wrinkles and monitor ocular surface changes and their effect on evaporative dry eye
      associated with MGD.
Subjects with skin laxity and evaporative dry eye will be recruited for enrollment in this
      study. Subjects must present with subjective and objective indicators for periorbital skin
      laxity and wrinkle grade of 2 or greater out of a 4 point scale. To qualify, subjects must
      present with high symptoms score on subjective Ocular Surface Disease Index© (OSDI©)
      Questionnaires (scores≥ 15); Rapid Tear Break up (< 5 seconds) and Grade ≥ 1 of Flourescein
      Staining in one area of the cornea. Each of these parameters are to be assessed prior to
      treatment and at each follow up visit. Treatment is to be performed on periorbital skin only
      around one eye of the subject using the THERMIeyes® standard protocol. This may result in
      some redness of the periorbital skin. Subjects are to be seen and treated 2-3 weeks apart for
      a total of 3 treatments. Subjects will be followed at 6 and 12 weeks after the final
      treatment. A Validated Grading Scale for Crow's Feet will be used to evaluate changes in skin
      wrinkles and dry eye signs and symptoms scores will be compared with pre-treatment findings.
observational model: Case-Only
time perspective: Prospective
measure: Skin Laxity
time frame: 5 Months
description: Subjective and Objective improvement in skin laxity and wrinkles using the validation Grading Scale for Crow's Feet
• To identify an improvement in the signs of dry eye defined as a decrease in total corneal staining after treatment compared with pre-treatment findings.
measure: Ocular Surface changes
time frame: 3 Months
description: Improvement in dry eye symptoms defined by a decrease in the OSDI score by 25% and decrease in total corneal staining
arm group label: Subjects between the ages of 40 - 70
description: Subjects who present with signs of skin laxity & evaporation dry eye will receive 3 treatments with the THERMIeyes® 20 RF System and monitored for improvements in the conditions for which they have presented.
intervention type: Device
intervention name: THERMIeyes® 20 RF System
description: The masked evaluating physician will be blinded as to which eye is treated. The evaluation on all visits will be performed on both eyes by the masked physician who will not know which eye has been treated with the THERMIeyes® 20 RF System. The treating technician will be aware of the treated eye so as to ensure all treatments are performed to the same eye.
arm group label: Subjects between the ages of 40 - 70
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerard D'Aversa, MD
role: Principal Investigator
affiliation: Ophthalmic Consultants of Long Island
last name: Carla DelCastillo
phone: 516-593-4026
email: cdelcastillo@ocli.net
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ophthalmic Consultants of Long Island
investigator full name: Gerard D'Aversa, MD
investigator title: Principal Investigator
mesh term: Meibomian Gland Dysfunction
sharing ipd: No
ipd description: We will not be sharing individual participant data with other researchers but do plan to present the total findings of the study.