<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/NCT04401865</url>
  </required_header>
  <id_info>
    <org_study_id>PXL-330</org_study_id>
    <nct_id>NCT04401865</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of the PXL-Platinum 330 System</brief_title>
  <official_title>Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado Eye Consultants/Cornea Consultants of Colorado</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado Eye Consultants/Cornea Consultants of Colorado</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing&#xD;
      corneal cross-linking (CXL) for the treatment of ectatic disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for&#xD;
      post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal&#xD;
      crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery.&#xD;
      Patients will undergo monitoring for 1 year, with serial measurements of corneal topography,&#xD;
      visual acuity, intraocular pressure, and pachymetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corrected distance visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uncorrected visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Change in UCVA at 6 months, compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratometry</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Kmax, compared to baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Corneal Ectasia</condition>
  <condition>Keratoconus</condition>
  <condition>Pellucid Marginal Corneal Degeneration</condition>
  <arm_group>
    <arm_group_label>Pulsed, Accelerated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>PXL-330 Platinum device for crosslinking with Peschke riboflavin solution</intervention_name>
    <description>Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea</description>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_label>Pulsed, Accelerated</arm_group_label>
    <other_name>Corneal cross-linking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid&#xD;
             marginal degeneration, forme fruste pellucid marginal degeneration, history of radial&#xD;
             keratotomy with fluctuating vision, Terrien's marginal degeneration.&#xD;
&#xD;
          2. Must have provided informed consent, documented it in writing, and have been given a&#xD;
             copy of the signed informed consent form.&#xD;
&#xD;
          3. Must be willing and able to return for scheduled treatment and follow-up examinations&#xD;
             for the duration of the study.&#xD;
&#xD;
          4. Must be at least 8 years of age.&#xD;
&#xD;
          5. Non-consenting/impaired individuals with a LAR's signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Corneal thickness &lt; 300 microns measured by ultrasound or Pentacam.&#xD;
&#xD;
          2. Contraindications or sensitivities to any study medications or their components.&#xD;
&#xD;
          3. Pregnancy or breastfeeding.&#xD;
&#xD;
          4. Any history of Herpes simplex corneal disease in an eye to be treated.&#xD;
&#xD;
          5. Nystagmus or any other condition that would, in the judgement of the investigator,&#xD;
             prevent a steady gaze during the treatment.&#xD;
&#xD;
          6. Inability to cooperate with diagnostic tests.&#xD;
&#xD;
          7. Current enrollment in another ophthalmic clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>S. Lance Forstot, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado Eye Consultants/Corneal Consultants of Colorado</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shivam Patel, BS</last_name>
    <phone>720-709-7523</phone>
    <email>spatel@corneaonline.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wendy Bigger</last_name>
    <phone>720-709-7533</phone>
    <email>wbigger@corneaonline.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Colorado Eye Consultants/Corneal Consultants of Colorado</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shivam Patel, BS</last_name>
      <phone>720-709-7523</phone>
      <email>spatel@corneaonline.com</email>
    </contact>
    <contact_backup>
      <last_name>Wendy Bigger</last_name>
      <phone>720-709-7533</phone>
      <email>wbigger@corneaonline.com</email>
    </contact_backup>
    <investigator>
      <last_name>S. Lance Forstot, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert I Fish, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karen M Repine, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chicago Cornea Consultants, Ltd.</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Eye Clinic</name>
      <address>
        <city>Brecksville</city>
        <state>Ohio</state>
        <zip>44141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Kus-Kreidler</last_name>
      <phone>216-503-6535</phone>
      <email>ekus-kreidler@clevelandeyeclinic.com</email>
    </contact>
    <investigator>
      <last_name>Shamik Bafna, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>William Wiley, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kathleen Jee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffrey Augustine, OD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kayla Karpuk, OD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</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>Keratoconus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04401865
org study id: PXL-330
nct id: NCT04401865
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing
      corneal cross-linking (CXL) for the treatment of ectatic disorders.
Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for
      post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal
      crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery.
      Patients will undergo monitoring for 1 year, with serial measurements of corneal topography,
      visual acuity, intraocular pressure, and pachymetry.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Corrected distance visual acuity
time frame: 6 months
description: Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.
measure: Uncorrected visual acuity
time frame: 6 months
description: Change in UCVA at 6 months, compared to baseline.
measure: Keratometry
time frame: 12 months
description: Change in Kmax, compared to baseline.
arm group label: Pulsed, Accelerated
arm group type: Experimental
description: 5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
arm group label: Conventional
arm group type: Active Comparator
description: 4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
intervention type: Combination Product
intervention name: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
description: Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
arm group label: Conventional
arm group label: Pulsed, Accelerated
other name: Corneal cross-linking
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: S. Lance Forstot, M.D.
role: Principal Investigator
affiliation: Colorado Eye Consultants/Corneal Consultants of Colorado
last name: Shivam Patel, BS
phone: 720-709-7523
email: spatel@corneaonline.com
last name: Wendy Bigger
phone: 720-709-7533
email: wbigger@corneaonline.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Riboflavin
sharing ipd: No