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/NCT05984290</url>
    </required_header>
    <id_info>
      <org_study_id>918</org_study_id>
      <nct_id>NCT05984290</nct_id>
    </id_info>
    <brief_title>Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens</brief_title>
    <official_title>Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (Oprifocon A) Shaping Lens in the Arise Orthokeratology Lens Design With Non-spherical Posterior Peripheral Curves</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bausch &amp; Lomb Incorporated</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bausch &amp; Lomb Incorporated</source>
    <oversight_info>
      <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>
        The objective of this orthokeratology study is to evaluate the safety and effectiveness of&#xD;
        the Arise Orthokeratology Lens with non-spherical posterior peripheral curves&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry orthokeratology&#xD;
        design that includes a base curve/treatment curve, a reverse curve, alignment curves and&#xD;
        peripheral curves. The base curve is used to only flatten the cornea and is not considered a&#xD;
        fitting curve. The parameters of the Arise Orthokeratology Lens are controlled to be within&#xD;
        the bounds determined by the spherical posterior curves of other lens designs prescribed for&#xD;
        the Bausch + Lomb Vision Shaping Treatment. The term peripheral curves excludes the base&#xD;
        curve and includes the zones defined as the reverse curve, alignment curves and peripheral&#xD;
        curves. Peripheral curves are designed to help control centration of the lens. When there are&#xD;
        elevation differences between the flat and steep meridians on the cornea (e.g., corneal&#xD;
        toricity), spherical peripheral curves, including the reverse curve, alignment curves and&#xD;
        peripheral curves, may not align completely to the cornea and can result in a lens with&#xD;
        sub-optimal centration. Aspheric curves and toric (e.g., dual axis) peripheral curves on&#xD;
        reverse geometry lenses for overnight orthokeratology have been available in the US market&#xD;
        for more than 10 years for fitting lenses. The intent of the Arise Orthokeratology Lens is to&#xD;
        provide a stable and centered lens that helps ensure the treatment zone of the lens is well&#xD;
        positioned in relation to the pupil and is shaping the central portion of the cornea for&#xD;
        optimal results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rate of serious adverse events at the subject and eye levels</measure>
      <time_frame>overnight over 3 months</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Astigmatism</condition>
    <arm_group>
      <arm_group_label>Safety and effectiveness of the Arise Orthokeratology Lens</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment effect of overnight orthokeratology over a 3-month period</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>orthokeratology lens</intervention_name>
      <description>Each subject will wear the study lenses in both eyes overnight for approximately 3 months.</description>
      <arm_group_label>Safety and effectiveness of the Arise Orthokeratology Lens</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants should be12 years or older on the date the Informed Consent Form (ICF) is&#xD;
               signed and, as subject or parent or legal guardian of a minor subject, have capacity&#xD;
               to read, understand and provide written voluntary informed consent on the IRB approved&#xD;
               ICF and provide authorization as appropriate for local privacy.&#xD;
  &#xD;
               regulations.&#xD;
  &#xD;
            2. orthokeratology lens naïve.&#xD;
  &#xD;
            3. Spherical refractive error no greater than -5.00D.&#xD;
  &#xD;
            4. Astigmatism no greater than 1.50D.&#xD;
  &#xD;
            5. Corneal topography sagittal height differential of ≥ 30 microns between the two main&#xD;
               meridians (flat and steep) at an 8mm chord.&#xD;
  &#xD;
            6. Participants should have keratometric readings from 39.00 to 48.00D.&#xD;
  &#xD;
            7. Participants should have a clear and undistorted Mire Reflex.&#xD;
  &#xD;
            8. Participants should be willing and able to comply with all treatment and follow-up&#xD;
               study visits and procedures.&#xD;
  &#xD;
            9. Participants must be willing to refrain from wearing habitual soft contact lenses&#xD;
               during the study period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject is considered by the Investigator, to not be a suitable candidate for&#xD;
               participation or it is not in the best interest of the subject to participate in the&#xD;
               study.&#xD;
  &#xD;
            2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30&#xD;
               days or who have worn polymethylmethacrylate (PMMA) lenses within the last three&#xD;
               months.&#xD;
  &#xD;
            3. Prior eyelid, strabismus, intraocular, or refractive surgery.&#xD;
  &#xD;
            4. Keratoconus or an irregular cornea.&#xD;
  &#xD;
            5. Subjects with any systemic disease currently affecting ocular health or in the&#xD;
               Investigator's opinion may have an effect on ocular health during the course of the&#xD;
               study.&#xD;
  &#xD;
            6. Subjects using any systemic or topical medications that will, in the Investigator's&#xD;
               opinion, affect ocular physiology or lens performance.&#xD;
  &#xD;
            7. A known allergy to fluorescein, benoxinate, or proparacaine.&#xD;
  &#xD;
            8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,&#xD;
               corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections.&#xD;
  &#xD;
            9. Subjects with an active ocular disease or who are using any ocular medication.&#xD;
  &#xD;
           10. Subjects with any Grade 2 or greater finding during the slit lamp examination.&#xD;
               Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to Appendix&#xD;
               B: Methods of Clinical Evaluation.&#xD;
  &#xD;
           11. Subjects with any &quot;Present&quot; finding during the slit lamp examination that, in the&#xD;
               Investigator's judgement, interferes with contact lens wear. Refer to Appendix B:&#xD;
               Methods of Clinical evaluation.&#xD;
  &#xD;
           12. Subjects with any scar or neovascularization within the central 6mm of the cornea.&#xD;
               Subjects with minor peripheral corneal scarring (that does not extend into the central&#xD;
               area), that in the Investigator's judgement, does not interfere with contact lens&#xD;
               wear, are eligible for this study.&#xD;
  &#xD;
           13. Subjects participating in any drug or device clinical investigation within 2 weeks&#xD;
               prior to entry into this study (Screening Visit) and/or planning to do so during the&#xD;
               period of study participation.&#xD;
  &#xD;
           14. Subjects who are amblyopic.&#xD;
  &#xD;
           15. Immediate family or close relative is a member of the office staff, including the&#xD;
               Investigator(s).&#xD;
  &#xD;
           16. Females of childbearing potential (those who are not surgically sterilized or&#xD;
               postmenopausal) if they meet any one of the following:&#xD;
  &#xD;
                 -  currently pregnant&#xD;
  &#xD;
                 -  plan to become pregnant during the study&#xD;
  &#xD;
                 -  breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Meg Swartzenberg</last_name>
      <phone>(585) 623-9588</phone>
      <email>Margaret.Swartzenberg@bausch.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Levenson Eye Associates</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32204</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Frank Mcdoland</last_name>
        <phone>904-366-3781</phone>
        <email>fwmcdonald@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Birmingham Vision Care P.C.</name>
        <address>
          <city>Bloomfield</city>
          <state>Michigan</state>
          <zip>48301</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patricia Poma-Nowinski</last_name>
        <phone>248-539-4800</phone>
        <email>drpoma@birminghamvision.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cornea and Contact Lens Institute of Minnesota</name>
        <address>
          <city>Edina</city>
          <state>Minnesota</state>
          <zip>55436</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zachary Holland</last_name>
        <phone>952-300-2151</phone>
        <email>zachary.holland10@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Koetting Associates</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63144</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nick Castellano</last_name>
        <phone>314-863-0000</phone>
        <email>ncastellano@koettingassociates.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Optometric Physicians of Middle Tennessee</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Richard Durocher</last_name>
        <phone>615-519-6242</phone>
        <email>RD@OPMT.COM</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Speciality Eyecare Group</name>
        <address>
          <city>Kirkland</city>
          <state>Washington</state>
          <zip>98034</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>David Kading</last_name>
        <phone>425-821-8900</phone>
        <email>drdave@specialtyeye.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Astigmatism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05984290
  org study id: 918
  nct id: NCT05984290
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The objective of this orthokeratology study is to evaluate the safety and effectiveness of
        the Arise Orthokeratology Lens with non-spherical posterior peripheral curves
  The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry orthokeratology
        design that includes a base curve/treatment curve, a reverse curve, alignment curves and
        peripheral curves. The base curve is used to only flatten the cornea and is not considered a
        fitting curve. The parameters of the Arise Orthokeratology Lens are controlled to be within
        the bounds determined by the spherical posterior curves of other lens designs prescribed for
        the Bausch + Lomb Vision Shaping Treatment. The term peripheral curves excludes the base
        curve and includes the zones defined as the reverse curve, alignment curves and peripheral
        curves. Peripheral curves are designed to help control centration of the lens. When there are
        elevation differences between the flat and steep meridians on the cornea (e.g., corneal
        toricity), spherical peripheral curves, including the reverse curve, alignment curves and
        peripheral curves, may not align completely to the cornea and can result in a lens with
        sub-optimal centration. Aspheric curves and toric (e.g., dual axis) peripheral curves on
        reverse geometry lenses for overnight orthokeratology have been available in the US market
        for more than 10 years for fitting lenses. The intent of the Arise Orthokeratology Lens is to
        provide a stable and centered lens that helps ensure the treatment zone of the lens is well
        positioned in relation to the pupil and is shaping the central portion of the cornea for
        optimal results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The rate of serious adverse events at the subject and eye levels
  time frame: overnight over 3 months
  arm group label: Safety and effectiveness of the Arise Orthokeratology Lens
  arm group type: Experimental
  description: Treatment effect of overnight orthokeratology over a 3-month period
  intervention type: Device
  intervention name: orthokeratology lens
  description: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
  arm group label: Safety and effectiveness of the Arise Orthokeratology Lens
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meg Swartzenberg
  phone: (585) 623-9588
  email: Margaret.Swartzenberg@bausch.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Astigmatism
  sharing ipd: No