xml: <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/NCT06034626</url>
    </required_header>
    <id_info>
      <org_study_id>2020-210</org_study_id>
      <nct_id>NCT06034626</nct_id>
    </id_info>
    <brief_title>Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction</brief_title>
    <acronym>MGD</acronym>
    <official_title>Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aier Eye Hospital, Wuhan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 aimed to determine the therapeutic effectiveness of different machines in intense&#xD;
        pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with&#xD;
        MGD underwent three sessions of IPL treatment in a control (M22) treatment group or&#xD;
        experimental (OPL-I) treatment group and were followed up three to four weeks after each&#xD;
        session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland&#xD;
        meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient&#xD;
        Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at&#xD;
        baseline and follow-up visits.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 3, 2020</start_date>
    <completion_date type="Actual">December 15, 2021</completion_date>
    <primary_completion_date type="Actual">August 10, 2021</primary_completion_date>
    <phase>Phase 3</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>The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Patients receiving IPL treatment were masked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>SPEED Scores</measure>
      <time_frame>Baseline, 1 month, 2 months, 3 months, 4 months</time_frame>
      <description>Standard Patient Evaluation of Eye Dryness questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CFS scores</measure>
      <time_frame>Baseline, 1 month, 2 months, 3 months, 4 months</time_frame>
      <description>corneal fluorescein staining scores</description>
    </primary_outcome>
    <primary_outcome>
      <measure>TBUT</measure>
      <time_frame>Baseline, 1 month, 2 months, 3 months, 4 months</time_frame>
      <description>Tear breakup time</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MGSS</measure>
      <time_frame>Baseline, 1 month, 2 months, 3 months, 4 months</time_frame>
      <description>Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MGMS</measure>
      <time_frame>Baseline, 1 month, 2 months, 3 months, 4 months</time_frame>
      <description>meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>BCVA</measure>
      <time_frame>Baseline, 4 months</time_frame>
      <description>best-corrected visual acuity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IOP</measure>
      <time_frame>Baseline, 4 months</time_frame>
      <description>intraocular pressure measurements</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">216</enrollment>
    <condition>MGD-Meibomian Gland Dysfunction</condition>
    <arm_group>
      <arm_group_label>OPL-I</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients treated with OPL-I with the dual filter system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>M22</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients treated with OPL-I with the single filter system</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intense pulsed light</intervention_name>
      <description>Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.</description>
      <arm_group_label>M22</arm_group_label>
      <arm_group_label>OPL-I</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.3% hyaluronic acid eye drops</intervention_name>
      <description>0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.</description>
      <arm_group_label>M22</arm_group_label>
      <arm_group_label>OPL-I</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance&#xD;
  &#xD;
            2. A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6&#xD;
  &#xD;
            3. Tear breakup time (TBUT) of ≤10 s in the studied eye&#xD;
  &#xD;
            4. Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this&#xD;
               criterion if the TBUT is ≤5 s)&#xD;
  &#xD;
            5. Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Use of prescription eye drops (excluding artificial tears) within 48 hours of&#xD;
               recruitment&#xD;
  &#xD;
            2. Facial IPL treatment within the prior 12 months&#xD;
  &#xD;
            3. Any surgery of the eye or eyelids within the prior six months&#xD;
  &#xD;
            4. Ocular surface and eyelid abnormalities&#xD;
  &#xD;
            5. Any systemic condition that might cause eye dryness&#xD;
  &#xD;
            6. Use of photosensitive drugs within the prior three months&#xD;
  &#xD;
            7. Precancerous lesions&#xD;
  &#xD;
            8. Skin cancer or pigmented lesions in the treatment area&#xD;
  &#xD;
            9. Overexposure to the sun within the previous month&#xD;
  &#xD;
           10. Ocular infections within the previous six months&#xD;
  &#xD;
           11. Uncontrolled infections or immunosuppressive diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiuming Jin, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hankou Aier Eye Hospital, Wuhan，Hubei Province</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Wuhan Aier Eye Hospital, Wuhan，Hubei Province</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>2nd Affiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.</citation>
      <PMID>25594770</PMID>
    </reference>
    <reference>
      <citation>Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, Huang X, Li J, Song W, Lin L, Cheng Y. The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Eye Contact Lens. 2021 Jan 1;47(1):45-53. doi: 10.1097/ICL.0000000000000711.</citation>
      <PMID>32452923</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>MGD</keyword>
    <keyword>IPL</keyword>
    <keyword>Non-inferiority analysis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Meibomian Gland Dysfunction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ophthalmic Solutions</mesh_term>
      <mesh_term>Hyaluronic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>For patients' privacy reasons</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034626
  org study id: 2020-210
  nct id: NCT06034626
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to determine the therapeutic effectiveness of different machines in intense
        pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with
        MGD underwent three sessions of IPL treatment in a control (M22) treatment group or
        experimental (OPL-I) treatment group and were followed up three to four weeks after each
        session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland
        meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient
        Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at
        baseline and follow-up visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Patients receiving IPL treatment were masked.
  measure: SPEED Scores
  time frame: Baseline, 1 month, 2 months, 3 months, 4 months
  description: Standard Patient Evaluation of Eye Dryness questionnaire
  measure: CFS scores
  time frame: Baseline, 1 month, 2 months, 3 months, 4 months
  description: corneal fluorescein staining scores
  measure: TBUT
  time frame: Baseline, 1 month, 2 months, 3 months, 4 months
  description: Tear breakup time
  measure: MGSS
  time frame: Baseline, 1 month, 2 months, 3 months, 4 months
  description: Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands.
  measure: MGMS
  time frame: Baseline, 1 month, 2 months, 3 months, 4 months
  description: meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum).
  measure: BCVA
  time frame: Baseline, 4 months
  description: best-corrected visual acuity
  measure: IOP
  time frame: Baseline, 4 months
  description: intraocular pressure measurements
  arm group label: OPL-I
  arm group type: Experimental
  description: Patients treated with OPL-I with the dual filter system
  arm group label: M22
  arm group type: Active Comparator
  description: Patients treated with OPL-I with the single filter system
  intervention type: Procedure
  intervention name: Intense pulsed light
  description: Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
  arm group label: M22
  arm group label: OPL-I
  intervention type: Drug
  intervention name: 0.3% hyaluronic acid eye drops
  description: 0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
  arm group label: M22
  arm group label: OPL-I
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xiuming Jin, PhD
  role: Study Director
  affiliation: Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
  facility: 
  facility: 
  facility: 
  country: China
  citation: Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.
  PMID: 25594770
  citation: Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, Huang X, Li J, Song W, Lin L, Cheng Y. The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Eye Contact Lens. 2021 Jan 1;47(1):45-53. doi: 10.1097/ICL.0000000000000711.
  PMID: 32452923
  responsible party type: Sponsor
  mesh term: Meibomian Gland Dysfunction
  mesh term: Ophthalmic Solutions
  mesh term: Hyaluronic Acid
  sharing ipd: No
  ipd description: For patients' privacy reasons