<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/NCT03788486</url>
  </required_header>
  <id_info>
    <org_study_id>TCQ2019</org_study_id>
    <nct_id>NCT03788486</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Treatment Device</brief_title>
  <official_title>A Phase 4 Study to Assess the Clinical Efficacy and Safety of Meibomian Gland Dysfunction and Dry Eye With an LED Blue Light Treatment Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toyos Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toyos Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the efficacy and safety of application of LED light to meibomian glands&#xD;
      in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will test the efficacy and safety of application of LED light to meibomian glands&#xD;
      in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.&#xD;
&#xD;
      The primary objective of the study is to investigate the safety and efficacy of blue LED&#xD;
      light with meibomian gland expression of the upper and lower eyelids in dry eye disease by&#xD;
      change from baseline in subjective questionnaire and by measurement of non-invasive tear&#xD;
      break up time.&#xD;
&#xD;
      Primary Endpoint: Improvement of tear break up time over the length of the study&#xD;
&#xD;
      Secondary endpoint: subjective patient comfort over the length of the study using a validated&#xD;
      dry eye comfort questionnaire administered at each study visit, VAS, 0= no pain and 100 =&#xD;
      maximal discomfort, Improvement in the number of corneal SPK that stain with fluorescein.&#xD;
&#xD;
      20 study subjects 18-85 will be enrolled with male or female in the Nashville and Memphis, TN&#xD;
      areas who are generally healthy but have signs and symptoms of dry eye disease with Meibomian&#xD;
      gland dysfunction.&#xD;
&#xD;
      phase 4&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Covid&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Anticipated">October 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Single site prospective study with no control group to assess the safety and clinical efficacy of a low power LED light device on the signs and symptoms of dry eye disease.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of non invasive tear break up time over the course of the study</measure>
    <time_frame>one month</time_frame>
    <description>3 measurements of non invasive tear break up time by investigator with average recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire</measure>
    <time_frame>one month</time_frame>
    <description>patient completed questionnaire 10 mm in length minimum score 0=no pain and maximal score 100= maximal pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of number of corneal spk stained with fluorescein over the course of the study</measure>
    <time_frame>one month</time_frame>
    <description>manual counting of number of corneal spk</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>2-3 Joule light device for MGD/Dry eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who qualify for the study will receive interventional in office treatments with the light treatment device in the upper and lower lids for defined periods of time twice weekly for a total of one month. Non-invasive tear break up, subjective questionnaires and corneal fluorescein staining will be measured through the course of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2-3 Joule LED blue light device</intervention_name>
    <description>application of blue light LED light device for 2 minutes in the central lower lids, temporal lower lids and upper temporal lids twice weekly under observation for one month</description>
    <arm_group_label>2-3 Joule light device for MGD/Dry eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form and HIPPA authorization.&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          3. Male or female, aged 18 -85.&#xD;
&#xD;
          4. Diagnosed with mild to severe dry eye in one or both eyes with evidence of Meibomian&#xD;
             gland dysfunction: cloudy or thick secretions, lack of secretions or presence of&#xD;
             telengiectasias on the lower lid margin.&#xD;
&#xD;
          5. History of persistent symptoms despite use of artificial tears.&#xD;
&#xD;
          6. Tear break up time of 7 seconds or less&#xD;
&#xD;
          7. Have normal lid anatomy.&#xD;
&#xD;
          8. Subject is able and willing to comply with the treatment, follow up schedule and&#xD;
             requirements.&#xD;
&#xD;
          9. For females of reproductive potential: use of highly effective contraception for at&#xD;
             least 1 month prior to screening and agreement to use such a method during study&#xD;
             participation and for an additional 4 weeks after the end of the study.&#xD;
&#xD;
         10. For males of reproductive potential: use of condoms or other methods to ensure&#xD;
             effective contraception with partner&#xD;
&#xD;
         11. Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have&#xD;
             undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni- or bilateral&#xD;
             oophorectomy, or bilateral oophorectomy.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a known hypersensitivity or contraindication to the investigational product or&#xD;
             components.&#xD;
&#xD;
          2. Pregnancy or lactation&#xD;
&#xD;
          3. Subjects can be on the following medications if they have been on a stable dose for 12&#xD;
             weeks: topical cyclosporine, topical liftigrast and/or topical loteprednol etabonate.&#xD;
             Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants,&#xD;
             retinoids, systemic immunosuppressive agents including oral corticosteroids,&#xD;
             non-steroidals, antihistamines, or mast cell stabilizers, punctal plugs, contact lens&#xD;
             wear and glaucoma medications.&#xD;
&#xD;
          4. Subjects must be unwilling to abstain from eyelash growth medications for the duration&#xD;
             of the trial.&#xD;
&#xD;
          5. Subjects must not have had penetrating intraocular surgery, refractive surgery or&#xD;
             corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.&#xD;
&#xD;
          6. Febrile illness within one week.&#xD;
&#xD;
          7. Treatment with another investigational drug or other intervention within one month.&#xD;
&#xD;
          8. Subjects with a history of herpetic keratitis.&#xD;
&#xD;
          9. Have serious or severe disease or uncontrolled medical condition that in the judgement&#xD;
             of the investigator could confound study assessments or limit compliance.&#xD;
&#xD;
         10. Neuro-paralysis or pre-cancerous lesions in the area to be treated.&#xD;
&#xD;
         11. Radiation to the head or neck within past 12 months.&#xD;
&#xD;
         12. Planned radiation therapy or chemotherapy.&#xD;
&#xD;
         13. Anticipated relocation or extensive travel outside of the local study area preventing&#xD;
             compliance with study procedures.&#xD;
&#xD;
         14. Legally blind in either eye.&#xD;
&#xD;
         15. Facial IPL treatment within 3 months of treatment.&#xD;
&#xD;
         16. Expression of Meibomian glands within 3 months prior to treatment.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rolando Toyos, MD</last_name>
    <role>Study Chair</role>
    <affiliation>owner</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dry eye</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>non-identifying patient data available upon request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>one year beginning 6 months after study completion</ipd_time_frame>
    <ipd_access_criteria>scientific researcher</ipd_access_criteria>
  </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/NCT03788486
org study id: TCQ2019
nct id: NCT03788486
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will test the efficacy and safety of application of LED light to meibomian glands
      in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.
This study will test the efficacy and safety of application of LED light to meibomian glands
      in upper and lower eyelids in eyes of patients suffering with meibomian gland disease.

      The primary objective of the study is to investigate the safety and efficacy of blue LED
      light with meibomian gland expression of the upper and lower eyelids in dry eye disease by
      change from baseline in subjective questionnaire and by measurement of non-invasive tear
      break up time.

      Primary Endpoint: Improvement of tear break up time over the length of the study

      Secondary endpoint: subjective patient comfort over the length of the study using a validated
      dry eye comfort questionnaire administered at each study visit, VAS, 0= no pain and 100 =
      maximal discomfort, Improvement in the number of corneal SPK that stain with fluorescein.

      20 study subjects 18-85 will be enrolled with male or female in the Nashville and Memphis, TN
      areas who are generally healthy but have signs and symptoms of dry eye disease with Meibomian
      gland dysfunction.

      phase 4
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single site prospective study with no control group to assess the safety and clinical efficacy of a low power LED light device on the signs and symptoms of dry eye disease.
primary purpose: Treatment
masking: None (Open Label)
measure: change of non invasive tear break up time over the course of the study
time frame: one month
description: 3 measurements of non invasive tear break up time by investigator with average recorded
measure: subjective patient comfort as measured by validated VAS (visual analog scale) dry eye comfort questionnaire
time frame: one month
description: patient completed questionnaire 10 mm in length minimum score 0=no pain and maximal score 100= maximal pain
measure: change of number of corneal spk stained with fluorescein over the course of the study
time frame: one month
description: manual counting of number of corneal spk
arm group label: 2-3 Joule light device for MGD/Dry eye
arm group type: Experimental
description: patients who qualify for the study will receive interventional in office treatments with the light treatment device in the upper and lower lids for defined periods of time twice weekly for a total of one month. Non-invasive tear break up, subjective questionnaires and corneal fluorescein staining will be measured through the course of the study.
intervention type: Device
intervention name: 2-3 Joule LED blue light device
description: application of blue light LED light device for 2 minutes in the central lower lids, temporal lower lids and upper temporal lids twice weekly under observation for one month
arm group label: 2-3 Joule light device for MGD/Dry eye
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rolando Toyos, MD
role: Study Chair
affiliation: owner
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Meibomian Gland Dysfunction
sharing ipd: Yes
ipd description: non-identifying patient data available upon request
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: one year beginning 6 months after study completion
ipd access criteria: scientific researcher