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/NCT06037850</url>
    </required_header>
    <id_info>
      <org_study_id>MCOK-01</org_study_id>
      <nct_id>NCT06037850</nct_id>
    </id_info>
    <brief_title>Clinical Trial of Orthokeratology Lens (MCOK-01)</brief_title>
    <official_title>Clinical Trial of Orthokeratology Lens (MCOK-01)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Menicon Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Menicon Co., Ltd.</source>
    <oversight_info>
      <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>
        A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The test product is the orthokeratology lens, and the control product is a commercially&#xD;
        available orthokeratology lens. The number of enrolled subjects is 390, and clinical&#xD;
        observation is performed for 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 29, 2022</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual acuity</measure>
      <time_frame>1 year</time_frame>
      <description>uncorrected visual acuity measured using logMAR chart</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Axial length</measure>
      <time_frame>1 year</time_frame>
      <description>axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Refraction</measure>
      <time_frame>1 year</time_frame>
      <description>spherical and cylinder power in diopter for best corrected visual acuity measured subjectively</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>1 year</time_frame>
      <description>Adverse events are classified into moderate, middle, or severe.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">390</enrollment>
    <condition>Myopia</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized to Treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Randomized to Control</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Test orthokeratology lens</intervention_name>
      <description>Randomized to test orthokeratology lens worn during sleep every night</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Control orthokeratology lens</intervention_name>
      <description>Randomized to control orthokeratology lens worn during sleep every night</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with myopia and myopic astigmatism&#xD;
  &#xD;
            2. Those who are not willing to wear glasses in daily life&#xD;
  &#xD;
            3. Fully understand of the purpose of the clinical trial and agree to sign the informed&#xD;
               consent form to participate in clinical trials, based on his/her willingness&#xD;
  &#xD;
            4. Those who can visit the institution on scheduled dates&#xD;
  &#xD;
            5. Those who can receive guidance and tests as required by the investigator&#xD;
  &#xD;
            6. Those who fully understand and follow the instructions of the lenses for this clinical&#xD;
               trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          &lt;At screening&gt;&#xD;
  &#xD;
            1. Best corrected vision acuity of less than 0.8 with spectacles&#xD;
  &#xD;
            2. Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D&#xD;
               or astigmatism greater than 1.5D&#xD;
  &#xD;
            3. Patients in need of treatment for eye disease other than refractive error (excluding&#xD;
               those receiving artificial tears eye drops due to the wearing of corneal contact&#xD;
               lenses)&#xD;
  &#xD;
            4. The medical history of intraocular surgery that may affect the effect of wearing the&#xD;
               lens for this clinical trial (those with corneal transplantation, Retinal detachment,&#xD;
               etc.)&#xD;
  &#xD;
            5. The medical history of refractive corneal surgery&#xD;
  &#xD;
            6. Those in need of a strength out of the scope of lens for this clinical trial&#xD;
  &#xD;
            7. Having eye allergic diseases that may cause disorders in wearing the lenses for this&#xD;
               clinical trial&#xD;
  &#xD;
            8. All Corneal abnormalities including keratoconus, corneal dystrophy, previous history&#xD;
               of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.&#xD;
  &#xD;
            9. Pregnant (judgment according to her known information) or those who plan to become&#xD;
               pregnant during clinical trial, or those who are breast feeding&#xD;
  &#xD;
           10. Those who are participating in other clinical trials or have participated in other&#xD;
               clinical trial in the past 30 days&#xD;
  &#xD;
           11. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft&#xD;
               lenses within the previous 3 days&#xD;
  &#xD;
           12. Prior experience with myopia control treatment (e.g. atropine, orthokeratology,&#xD;
               multifocal soft contact lenses)&#xD;
  &#xD;
           13. Minor/adult subjects who lack mental capacity&#xD;
  &#xD;
           14. Other not suitable for this clinical trial at investigator's discretion &lt;At the&#xD;
               beginning of the wearing&gt;&#xD;
  &#xD;
          (1) Those who are determined to be unable to obtain good centralized positioning even&#xD;
          though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing&#xD;
          the clinical trial at investigator's discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stan Isaacs</last_name>
      <role>Study Director</role>
      <affiliation>I &amp; Vision Research Centre Pte. Ltd.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>I&amp;VISION Research Centre</name>
        <address>
          <city>Singapore</city>
          <zip>248649</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Myopia Specialist Centre</name>
        <address>
          <city>Singapore</city>
          <zip>248649</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Stan Isaacs</name>
        <address>
          <city>Singapore</city>
          <zip>248649</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myopia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06037850
  org study id: MCOK-01
  nct id: NCT06037850
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
  The test product is the orthokeratology lens, and the control product is a commercially
        available orthokeratology lens. The number of enrolled subjects is 390, and clinical
        observation is performed for 12 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual acuity
  time frame: 1 year
  description: uncorrected visual acuity measured using logMAR chart
  measure: Axial length
  time frame: 1 year
  description: axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
  measure: Refraction
  time frame: 1 year
  description: spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
  measure: Adverse Events
  time frame: 1 year
  description: Adverse events are classified into moderate, middle, or severe.
  arm group label: Treatment
  arm group type: Experimental
  description: Randomized to Treatment
  arm group label: Control
  arm group type: Active Comparator
  description: Randomized to Control
  intervention type: Device
  intervention name: Test orthokeratology lens
  description: Randomized to test orthokeratology lens worn during sleep every night
  arm group label: Treatment
  intervention type: Device
  intervention name: Control orthokeratology lens
  description: Randomized to control orthokeratology lens worn during sleep every night
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stan Isaacs
  role: Study Director
  affiliation: I & Vision Research Centre Pte. Ltd.
  facility: 
  facility: 
  facility: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Myopia