<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/NCT03265652</url>
  </required_header>
  <id_info>
    <org_study_id>LUM-VBU-IPL-M22-17-02</org_study_id>
    <secondary_id>0171-17-SZMC</secondary_id>
    <nct_id>NCT03265652</nct_id>
  </id_info>
  <brief_title>IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD</brief_title>
  <official_title>Intense Pulsed Light and Meibomian Gland Expression (MGX) Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to Meibomian Gland Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lumenis Be Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lumenis Be Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study is to examine the contribution of intense pulsed light (IPL) for&#xD;
      relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL&#xD;
      will be examined in a study designed as a randomized controlled trial. In the study arm,&#xD;
      subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by&#xD;
      expression of the meibomian glands. In the control arm, subjects will undergo the same&#xD;
      treatments, except that the IPL pulses will be disabled. For each subject, the duration of&#xD;
      the study will be 10 weeks, as explained in the detailed description,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment,&#xD;
      number of meibomian glands yielding liquid secretion in lower eyelid , meibography,&#xD;
      self-assessed symptoms and close up photos of the lid margins) will be measured at baseline.&#xD;
      All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a&#xD;
      subject allocated to the study group will be treated with IPL administered in the malar&#xD;
      region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately&#xD;
      following the IPL administration, the meibomian glands will be manually expressed from both&#xD;
      eyelids. Subjects in the control arm will receive exactly the same treatment, except that the&#xD;
      IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline&#xD;
      (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome&#xD;
      measures will be evaluated, and compared between the two arms.&#xD;
&#xD;
      For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd&#xD;
      treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment&#xD;
      at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).&#xD;
&#xD;
      Statistically significant differences between the two arms will support the study hypothesis&#xD;
      that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Actual">April 18, 2019</completion_date>
  <primary_completion_date type="Actual">April 18, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects in the study arm will receive a series of IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of baseline TBUT</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of Tear break up time in the study eye, from baseline to follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline MGA</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline OSDI</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline MGYLS</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of the number of meibomian glands yielding liquid secretion, from baseline to the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline TFO</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of the tear film osmolarity, from baseline to the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Meiboscore</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change of the Meiboscore evaluated with meibography, from baseline to the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of study eyes with normal TBUT</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage of study eyes with TBUT &gt; 10 seconds at the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of subjects with normal OSDI</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage of subjects with OSDI &lt; 23 at the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of subjects with normal MGA</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage of eyes with MGA &gt; 12 at the follow-up</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative assessment of eyelid appearance</measure>
    <time_frame>10 weeks</time_frame>
    <description>High resolution photos of the upper and lower eyelids in both eyes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Dry Eye</condition>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>Intense Pulsed Light (IPL) therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Pulsed Light (IPL) therapy</intervention_name>
    <description>Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.</description>
    <arm_group_label>Intense Pulsed Light (IPL) therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham therapy</intervention_name>
    <description>Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.</description>
    <arm_group_label>Sham therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is able to read, understand and sign an Informed Consent (IC) form&#xD;
&#xD;
          2. Subject is 18 years or older&#xD;
&#xD;
          3. Subject has Fitzpatrick skin type I to IV&#xD;
&#xD;
          4. SPEED questionnaire equal or more than 10&#xD;
&#xD;
          5. OSDI questionnaire equal or more than 23&#xD;
&#xD;
          6. In both eyes, at least 5 non-atrophied meibomian glands on the lower eyelid.&#xD;
&#xD;
          7. In both eyes, Tear break up time equal or less than 7 seconds&#xD;
&#xD;
          8. In both eyes, MGA (the total meibomian gland score for 15 glands of the lower eyelid)&#xD;
             is smaller or equal to 12&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contact lens wear within the month prior to screening&#xD;
&#xD;
          2. Unwilling to discontinue use of contact lenses for the duration of the study&#xD;
&#xD;
          3. Ocular surgery or eyelid surgery within 6 months prior to screening&#xD;
&#xD;
          4. Neuro-paralysis in the planned treatment area within 6 months prior to screening&#xD;
&#xD;
          5. Other uncontrolled eye disorders affecting the ocular surface, for example active&#xD;
             allergies&#xD;
&#xD;
          6. Current use of punctal plugs&#xD;
&#xD;
          7. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area&#xD;
&#xD;
          8. Uncontrolled infections or uncontrolled immunosuppressive diseases&#xD;
&#xD;
          9. Subjects with ocular infections within 6 months prior to screening&#xD;
&#xD;
         10. Prior history of cold sores or rashes in the perioral area or in the planned treatment&#xD;
             area that could be stimulated by light at a wavelength of 560 nm to 1200 nm (e.g.,&#xD;
             Herpes simplex 1 &amp; 2, Systemic Lupus erythematosus, porphyria)&#xD;
&#xD;
         11. Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200&#xD;
             nm light exposure, such as Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort&#xD;
             within 3 months prior to screening&#xD;
&#xD;
         12. Over exposure to sun within 4 weeks prior to screening, in the judgment of the&#xD;
             investigator&#xD;
&#xD;
         13. Administration of prescription eye drops for dry eye within 7 days prior to screening,&#xD;
             excluding artificial tears and glaucoma drops&#xD;
&#xD;
         14. Radiation therapy to the head or neck within 12 months prior to screening, or planned&#xD;
             radiation therapy within 8 weeks after completion of all IPL treatments&#xD;
&#xD;
         15. Treatment with chemotherapeutic agent within 8 weeks prior to screening, or planned&#xD;
             chemotherapy within 8 weeks after completion of all IPL treatments&#xD;
&#xD;
         16. New topical treatments within the area to be treated, or oral therapies within 3&#xD;
             months prior to screening, except over-the-counter acetaminophen-based analgesics&#xD;
             (such as Extra Strength Tylenol®) for pain management after study treatment, new oral&#xD;
             omega 3 fatty acid supplements and topical artificial tears&#xD;
&#xD;
         17. Change in dosage of any systemic medication within 3 months prior to screening&#xD;
&#xD;
         18. Anticipated relocation or extensive travel outside of the local study area preventing&#xD;
             compliance with follow-up over the study period&#xD;
&#xD;
         19. Legally blind in either or both eyes&#xD;
&#xD;
         20. History of migraines, seizures or epilepsy&#xD;
&#xD;
         21. IPL treatment within 12 months prior to screening&#xD;
&#xD;
         22. Lipiflow treatment, or any other thermal treatment of the eyelids, within 6 months&#xD;
             prior to screening&#xD;
&#xD;
         23. Expression of the meibomian glands within 6 months prior to screening&#xD;
&#xD;
         24. Any condition revealed during the eligibility screening process whereby the&#xD;
             investigator deems the subject inappropriate for this study&#xD;
&#xD;
         25. Women below the age of menopause (50 years of age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Zadok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaarei Zedek Hospital ( Jerusalem)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shaare Zedek</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intense Pulsed Light</keyword>
  <keyword>Meibomian Gland Dysfunction</keyword>
  <keyword>Dry Eye Disease</keyword>
  <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>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>At this point it is not yet decided if and how to share IPD with other researchers</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/NCT03265652
org study id: LUM-VBU-IPL-M22-17-02
secondary id: 0171-17-SZMC
nct id: NCT03265652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the current study is to examine the contribution of intense pulsed light (IPL) for
      relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL
      will be examined in a study designed as a randomized controlled trial. In the study arm,
      subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by
      expression of the meibomian glands. In the control arm, subjects will undergo the same
      treatments, except that the IPL pulses will be disabled. For each subject, the duration of
      the study will be 10 weeks, as explained in the detailed description,
Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment,
      number of meibomian glands yielding liquid secretion in lower eyelid , meibography,
      self-assessed symptoms and close up photos of the lid margins) will be measured at baseline.
      All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a
      subject allocated to the study group will be treated with IPL administered in the malar
      region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately
      following the IPL administration, the meibomian glands will be manually expressed from both
      eyelids. Subjects in the control arm will receive exactly the same treatment, except that the
      IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline
      (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome
      measures will be evaluated, and compared between the two arms.

      For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd
      treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment
      at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).

      Statistically significant differences between the two arms will support the study hypothesis
      that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
primary purpose: Treatment
masking: Single (Participant)
masking description: Subjects in the study arm will receive a series of IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort
measure: Change of baseline TBUT
time frame: 10 weeks
description: Change of Tear break up time in the study eye, from baseline to follow-up
measure: Change from baseline MGA
time frame: 10 weeks
description: Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes
measure: Change from baseline OSDI
time frame: 10 weeks
description: Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes
measure: Change from baseline MGYLS
time frame: 10 weeks
description: Change of the number of meibomian glands yielding liquid secretion, from baseline to the follow-up
measure: Change from baseline TFO
time frame: 10 weeks
description: Change of the tear film osmolarity, from baseline to the follow-up
measure: Change from baseline Meiboscore
time frame: 10 weeks
description: Change of the Meiboscore evaluated with meibography, from baseline to the follow-up
measure: Percentage of study eyes with normal TBUT
time frame: 10 weeks
description: Percentage of study eyes with TBUT > 10 seconds at the follow-up
measure: Percentage of subjects with normal OSDI
time frame: 10 weeks
description: Percentage of subjects with OSDI < 23 at the follow-up
measure: Percentage of subjects with normal MGA
time frame: 10 weeks
description: Percentage of eyes with MGA > 12 at the follow-up
measure: Qualitative assessment of eyelid appearance
time frame: 10 weeks
description: High resolution photos of the upper and lower eyelids in both eyes
arm group label: Intense Pulsed Light (IPL) therapy
arm group type: Experimental
description: Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.
arm group label: Sham therapy
arm group type: Placebo Comparator
description: Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.
intervention type: Device
intervention name: Intense Pulsed Light (IPL) therapy
description: Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
arm group label: Intense Pulsed Light (IPL) therapy
intervention type: Device
intervention name: Sham therapy
description: Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
arm group label: Sham therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Zadok, MD
role: Principal Investigator
affiliation: Shaarei Zedek Hospital ( Jerusalem)
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Meibomian Gland Dysfunction
sharing ipd: Undecided
ipd description: At this point it is not yet decided if and how to share IPD with other researchers