<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/NCT04454983</url>
  </required_header>
  <id_info>
    <org_study_id>PEC-Sep2019-Lipi-iLux</org_study_id>
    <nct_id>NCT04454983</nct_id>
  </id_info>
  <brief_title>Lipiflow vs iLux Patient Acceptance and Comfort Study</brief_title>
  <official_title>Lipiflow vs iLux Patient Acceptance and Comfort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epstein, Arthur B., OD, FAAO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johnson &amp; Johnson Vision Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Epstein, Arthur B., OD, FAAO</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to compare patient acceptance, comfort, and preference between two&#xD;
      meibomian gland clearing devices (Lipiflow vs, iLux). Primary Objective was to compare&#xD;
      patient comfort as assessed by Likert-style scale questionnaire following each bilateral&#xD;
      procedure. Secondary Objective was to compare overall experience and treatment preference as&#xD;
      assessed by Likert-style questionnaire following each bilateral procedure. Both devices are&#xD;
      exempt from IDE regulations [21 CFR 812.2(c)].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Meibomian gland disease (MGD) is increasingly recognized as a primary cause or&#xD;
      contributor to tear instability and dry eye disease. Effective management of this disorder&#xD;
      often requires meibomian gland expression and clearance. A variety of devices which apply&#xD;
      pressure, heat or a combination of both to the glands have been used.&#xD;
&#xD;
      Two such devices that apply heat and pressure simultaneously are commercially available.&#xD;
      LipiFlow (JNJ Vision Care) is an automated computer-controlled device that uses vectored&#xD;
      thermal (hydraulic) pulsation applied by an activator device placed on the eye between the&#xD;
      globe and the eyelids to achieve gland clearance. The iLux System (Alcon) is an operator&#xD;
      controlled assisted manual device which applies heat generated by infrared LEDs and&#xD;
      expression through cam driven mechanical pressure applied to the lids.&#xD;
&#xD;
      Device Descriptions LipiFlow Thermal Pulsation System&#xD;
&#xD;
      The Lipiflow Thermal Pulsation System is a commercially available device used in the&#xD;
      treatment of MGD. It is cleared to be marketed by the United States Food and Drug&#xD;
      Administration. The LipiFlow Thermal Pulsation System is intended for the application of&#xD;
      localized heat and pressure therapy in adult patients with chronic cystic conditions of the&#xD;
      eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or&#xD;
      lipid deficiency dry eye.&#xD;
&#xD;
      The LipiFlow Console provides the user interface and control elements of the system,&#xD;
      including all software, algorithms and control elements. The Activator, a single-use sterile&#xD;
      device, delivers automated therapeutic energies to each meibomian gland. Its contoured design&#xD;
      vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43&#xD;
      degrees Celsius to reach glands from the inner eyelid, without damaging the eyelid or&#xD;
      delicate structures of the globe. Insulation protects the cornea from exceeding a safe 39.5&#xD;
      degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages.&#xD;
      Force equalization protects the globe from pressure transmission by focusing energy only on&#xD;
      the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ (VTP)&#xD;
      technology applies a combination of heat and pressure to the inner eyelid to safely remove&#xD;
      gland obstructions and stagnant gland content. Vectored heat and adaptive force equalization&#xD;
      target the pulse, heat, and pressure on the meibomian glands to maximize effectiveness.&#xD;
      Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.&#xD;
&#xD;
      iLux System&#xD;
&#xD;
      The iLux™ System is a medical device commercially available for use by Eye Care Professionals&#xD;
      (ECP) to apply localized heat and pressure therapy to a patient's eyelids. It is cleared to&#xD;
      be marketed by the United States Food and Drug Administration. The system consists of a&#xD;
      handheld instrument coupled to a single-use, sterile disposable component that is positioned&#xD;
      to bridge the eyelid. The iLux device allows an ECP to view the eyelid margin through a&#xD;
      magnifier, then warm the eyelid tissue to a range of 40 to 42˚C, and then apply force-limited&#xD;
      compression to the eyelid in order to express melted meibum from obstructed glands. The iLux&#xD;
      System is indicated for the application of localized heat and pressure therapy in adult&#xD;
      patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction&#xD;
      (MGD), also known as evaporative dry eye.&#xD;
&#xD;
      The iLux Instrument is a handheld, electronic instrument used together with the iLux&#xD;
      disposable to apply heating and pressure to the eyelid. The Instrument includes electronic&#xD;
      circuits that read sensors in the Inner and Outer Eyelid Pads to measure temperatures&#xD;
      representative of inner and outer eyelid temperature, respectively. Warming is accomplished&#xD;
      using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear&#xD;
      window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm)&#xD;
      and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply&#xD;
      pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure&#xD;
      applied to the Compression Control button. The force applied to the Compression Control is&#xD;
      measured by a sensor in this mechanism. A graphic Screen displays information for operating&#xD;
      the Instrument during a treatment.&#xD;
&#xD;
      Study Purpose / Objectives This study is designed to compare patient acceptance, comfort, and&#xD;
      preference between two meibomian gland clearing devices. Both devices are exempt from IDE&#xD;
      regulations [21 CFR 812.2(c)]. Primary Objective is to compare patient comfort as assessed by&#xD;
      Likert-style scale questionnaire following each bilateral procedure. Secondary Objective is&#xD;
      to compare overall experience and treatment preference as assessed by Likert-style&#xD;
      questionnaire following each bilateral procedure.&#xD;
&#xD;
      Background &quot;Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland&#xD;
      Dysfunction&quot; listed on ClincalTrials.gov looked at a 4-week efficacy comparison between the&#xD;
      two treatment devices. Pain and discomfort data were collected regarding the two procedures&#xD;
      but was not analyzed for significance due to no pre-trial hypothesis. The raw data shows&#xD;
      lower pain and discomfort scores immediately following the procedure for the Lipiflow as&#xD;
      compared to iLux with similar pre-treatment and one-day post post-treatment scores (Thornhill&#xD;
      2019). There is currently no published research on the patient acceptance, comfort, and&#xD;
      preference comparing any meibomian gland emptying devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2020</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This study is an open-label, single site, crossover trial comparing LipiFlow Thermal Pulsation System to the iLux System based on patient acceptance, comfort, and preference.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure Comfort</measure>
    <time_frame>5 minutes</time_frame>
    <description>Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 1 Question</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure Experience</measure>
    <time_frame>5 minutes</time_frame>
    <description>Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 4 Questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Preference</measure>
    <time_frame>5 minutes</time_frame>
    <description>Questionnaire: Lipiflow, iLux, No Preference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Lipiflow - All Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iLux - All Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipiflow Thermal Pulsation System</intervention_name>
    <description>The LipiFlow Console provides the user interface and control elements of the system, including all software, algorithms and control elements. The Activator, a single-use sterile device, delivers automated therapeutic energies to each meibomian gland. Its contoured design vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43 degrees Celsius to reach glands from the inner eyelid. Insulation protects the cornea from exceeding a safe 39.5 degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages. Force equalization protects the globe from pressure transmission by focusing energy only on the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.</description>
    <arm_group_label>Lipiflow - All Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iLux System</intervention_name>
    <description>The iLux™ System is used to apply localized heat and pressure to a patient's eyelids. The system consists of a handheld instrument coupled to a single-use, sterile disposable component that is positioned to bridge the eyelid. The iLux device allows view of the eyelid through a magnifier, then warms the eyelid to 40 to 42˚C, then force-limited compression is applied manually to express the melted meibum from obstructed glands. Warming is accomplished using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm) and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure applied to the Compression Control button. The force applied to the Compression Control is measured by a sensor in this mechanism.</description>
    <arm_group_label>iLux - All Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject can be of any gender or race&#xD;
&#xD;
          2. Subject must be 18 years of age or older at the time of informed consent&#xD;
&#xD;
        2. Subject must be able to understand and must sign an Informed Consent that has been&#xD;
        approved by an IRB 3. Subject must have confirmed diagnosis of Meibomian Gland Dysfunction&#xD;
        4. Subject must agree to not wear contact lenses the day of the Study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of intraocular or oculoplastic surgery within 6 months of Screening visit&#xD;
&#xD;
          2. History of ocular injury or trauma, chemical burns, or limbal stem cell deficiency&#xD;
             within 3 months of the Screening visit&#xD;
&#xD;
          3. Active ocular infection or active ocular inflammation (including allergic&#xD;
             conjunctivitis, vernal or giant papillary conjunctivitis) at time of Screening visit&#xD;
&#xD;
          4. History of ocular surface abnormality that may compromise corneal integrity&#xD;
&#xD;
          5. History of treatment with LipiFlow or iLux in either eye in the last 6 months&#xD;
&#xD;
          6. Allergy to topical proparacaine eye drops&#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>
  <overall_official>
    <last_name>Arthur B Epstein, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophthalmic Research Consultants of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Eye Care</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03055832</url>
    <description>Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Epstein, Arthur B., OD, FAAO</investigator_affiliation>
    <investigator_full_name>Dr. Arthur Epstein</investigator_full_name>
    <investigator_title>Director of Dry Eye and Ocular Surface Disease</investigator_title>
  </responsible_party>
  <keyword>meibomian gland dysfunction</keyword>
  <keyword>dry eye</keyword>
  <keyword>Lipiflow</keyword>
  <keyword>iLux</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>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04454983/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04454983
org study id: PEC-Sep2019-Lipi-iLux
nct id: NCT04454983
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study was designed to compare patient acceptance, comfort, and preference between two
      meibomian gland clearing devices (Lipiflow vs, iLux). Primary Objective was to compare
      patient comfort as assessed by Likert-style scale questionnaire following each bilateral
      procedure. Secondary Objective was to compare overall experience and treatment preference as
      assessed by Likert-style questionnaire following each bilateral procedure. Both devices are
      exempt from IDE regulations [21 CFR 812.2(c)].
Introduction Meibomian gland disease (MGD) is increasingly recognized as a primary cause or
      contributor to tear instability and dry eye disease. Effective management of this disorder
      often requires meibomian gland expression and clearance. A variety of devices which apply
      pressure, heat or a combination of both to the glands have been used.

      Two such devices that apply heat and pressure simultaneously are commercially available.
      LipiFlow (JNJ Vision Care) is an automated computer-controlled device that uses vectored
      thermal (hydraulic) pulsation applied by an activator device placed on the eye between the
      globe and the eyelids to achieve gland clearance. The iLux System (Alcon) is an operator
      controlled assisted manual device which applies heat generated by infrared LEDs and
      expression through cam driven mechanical pressure applied to the lids.

      Device Descriptions LipiFlow Thermal Pulsation System

      The Lipiflow Thermal Pulsation System is a commercially available device used in the
      treatment of MGD. It is cleared to be marketed by the United States Food and Drug
      Administration. The LipiFlow Thermal Pulsation System is intended for the application of
      localized heat and pressure therapy in adult patients with chronic cystic conditions of the
      eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or
      lipid deficiency dry eye.

      The LipiFlow Console provides the user interface and control elements of the system,
      including all software, algorithms and control elements. The Activator, a single-use sterile
      device, delivers automated therapeutic energies to each meibomian gland. Its contoured design
      vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43
      degrees Celsius to reach glands from the inner eyelid, without damaging the eyelid or
      delicate structures of the globe. Insulation protects the cornea from exceeding a safe 39.5
      degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages.
      Force equalization protects the globe from pressure transmission by focusing energy only on
      the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ (VTP)
      technology applies a combination of heat and pressure to the inner eyelid to safely remove
      gland obstructions and stagnant gland content. Vectored heat and adaptive force equalization
      target the pulse, heat, and pressure on the meibomian glands to maximize effectiveness.
      Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.

      iLux System

      The iLux™ System is a medical device commercially available for use by Eye Care Professionals
      (ECP) to apply localized heat and pressure therapy to a patient's eyelids. It is cleared to
      be marketed by the United States Food and Drug Administration. The system consists of a
      handheld instrument coupled to a single-use, sterile disposable component that is positioned
      to bridge the eyelid. The iLux device allows an ECP to view the eyelid margin through a
      magnifier, then warm the eyelid tissue to a range of 40 to 42˚C, and then apply force-limited
      compression to the eyelid in order to express melted meibum from obstructed glands. The iLux
      System is indicated for the application of localized heat and pressure therapy in adult
      patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction
      (MGD), also known as evaporative dry eye.

      The iLux Instrument is a handheld, electronic instrument used together with the iLux
      disposable to apply heating and pressure to the eyelid. The Instrument includes electronic
      circuits that read sensors in the Inner and Outer Eyelid Pads to measure temperatures
      representative of inner and outer eyelid temperature, respectively. Warming is accomplished
      using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear
      window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm)
      and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply
      pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure
      applied to the Compression Control button. The force applied to the Compression Control is
      measured by a sensor in this mechanism. A graphic Screen displays information for operating
      the Instrument during a treatment.

      Study Purpose / Objectives This study is designed to compare patient acceptance, comfort, and
      preference between two meibomian gland clearing devices. Both devices are exempt from IDE
      regulations [21 CFR 812.2(c)]. Primary Objective is to compare patient comfort as assessed by
      Likert-style scale questionnaire following each bilateral procedure. Secondary Objective is
      to compare overall experience and treatment preference as assessed by Likert-style
      questionnaire following each bilateral procedure.

      Background "Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland
      Dysfunction" listed on ClincalTrials.gov looked at a 4-week efficacy comparison between the
      two treatment devices. Pain and discomfort data were collected regarding the two procedures
      but was not analyzed for significance due to no pre-trial hypothesis. The raw data shows
      lower pain and discomfort scores immediately following the procedure for the Lipiflow as
      compared to iLux with similar pre-treatment and one-day post post-treatment scores (Thornhill
      2019). There is currently no published research on the patient acceptance, comfort, and
      preference comparing any meibomian gland emptying devices.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is an open-label, single site, crossover trial comparing LipiFlow Thermal Pulsation System to the iLux System based on patient acceptance, comfort, and preference.
primary purpose: Other
masking: None (Open Label)
measure: Procedure Comfort
time frame: 5 minutes
description: Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 1 Question
measure: Procedure Experience
time frame: 5 minutes
description: Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 4 Questions
measure: Patient Preference
time frame: 5 minutes
description: Questionnaire: Lipiflow, iLux, No Preference
arm group label: Lipiflow - All Subjects
arm group type: Experimental
description: Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.
arm group label: iLux - All Subjects
arm group type: Experimental
description: Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.
intervention type: Device
intervention name: Lipiflow Thermal Pulsation System
description: The LipiFlow Console provides the user interface and control elements of the system, including all software, algorithms and control elements. The Activator, a single-use sterile device, delivers automated therapeutic energies to each meibomian gland. Its contoured design vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43 degrees Celsius to reach glands from the inner eyelid. Insulation protects the cornea from exceeding a safe 39.5 degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages. Force equalization protects the globe from pressure transmission by focusing energy only on the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.
arm group label: Lipiflow - All Subjects
intervention type: Device
intervention name: iLux System
description: The iLux™ System is used to apply localized heat and pressure to a patient's eyelids. The system consists of a handheld instrument coupled to a single-use, sterile disposable component that is positioned to bridge the eyelid. The iLux device allows view of the eyelid through a magnifier, then warms the eyelid to 40 to 42˚C, then force-limited compression is applied manually to express the melted meibum from obstructed glands. Warming is accomplished using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm) and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure applied to the Compression Control button. The force applied to the Compression Control is measured by a sensor in this mechanism.
arm group label: iLux - All Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur B Epstein, OD
role: Principal Investigator
affiliation: Ophthalmic Research Consultants of Arizona
facility: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT03055832
description: Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
responsible party type: Principal Investigator
investigator affiliation: Epstein, Arthur B., OD, FAAO
investigator full name: Dr. Arthur Epstein
investigator title: Director of Dry Eye and Ocular Surface Disease
mesh term: Dry Eye Syndromes
mesh term: Meibomian Gland Dysfunction
sharing ipd: No
ipd description: There is not a plan to make IPD available.
provided document: 