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/NCT05973409</url>
    </required_header>
    <id_info>
      <org_study_id>SEC-P052021</org_study_id>
      <nct_id>NCT05973409</nct_id>
    </id_info>
    <brief_title>Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye</brief_title>
    <official_title>Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Coopervision, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Coopervision, Inc.</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>
        This study is being conducted to determine if scleral lenses coated with Hydra-PED improve&#xD;
        comfort and dryness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of the study is to determine if scleral lenses with and scleral lenses without&#xD;
        Hydra-PEG coating provide positive improvement in ocular comfort and dryness scores.&#xD;
  &#xD;
        The effect of the study lenses and the coating, will be compared in a group of symptomatic&#xD;
        soft lens wearers, and also in a group of symptomatic non contact lens wearers.&#xD;
  &#xD;
        The primary outcome variable for this study is &quot;overall ocular comfort&quot; reported at the&#xD;
        screening visit for the habitual vision correction, and at the 4-week follow-up visits for&#xD;
        each of the two study lenses. using a 0-10 scale (0.5 steps).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>At the fitting visit, only uncoated lenses will be used to determine the parameters of the lenses to be ordered. At both dispense visits, participants and investigators will be masked to the lens type dispensed. In order to achieve this, unmasked study personnel will determine the order of lens wear according to the randomization schedule and they will not share the lens labels or packs with the investigator. Instead, the lenses will be transferred to an unmarked case/container prior to being provided at the Dispense visit.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>overall ocular comfort</measure>
      <time_frame>4 weeks</time_frame>
      <description>reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Dry Eye</condition>
    <arm_group>
      <arm_group_label>Habitual Soft Lens Wearers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non Contact Lens Wearers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>scleral lens</intervention_name>
      <description>scleral lens with and without hydra-peg coating</description>
      <arm_group_label>Habitual Soft Lens Wearers</arm_group_label>
      <arm_group_label>Non Contact Lens Wearers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Are at least 17 years of age and have full legal capacity to volunteer;&#xD;
  &#xD;
            2. Have read and signed an information consent letter;&#xD;
  &#xD;
            3. Are willing and able to follow instructions and maintain the appointment schedule;&#xD;
  &#xD;
            4. Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;&#xD;
  &#xD;
            5. Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than&#xD;
               -3.00DC in each eye;&#xD;
  &#xD;
            6. Have best corrected visual acuity of 20/40 or better in each eye with the study&#xD;
               lenses;&#xD;
  &#xD;
            7. Demonstrate an acceptable fit with the study lenses;&#xD;
  &#xD;
            8. Have no active ocular disease or inflammation;&#xD;
  &#xD;
            9. Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;&#xD;
  &#xD;
           10. Group 2: Have not worn contact lenses for 6 months;&#xD;
  &#xD;
           11. Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;&#xD;
  &#xD;
           12. Group 2: Non contact lens wearers should score ≥13 on OSDI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Are participating in any concurrent clinical or research study, or have done so within&#xD;
               the past 30 days;&#xD;
  &#xD;
            2. Cannot achieve a successful lens fit or vision with the study lens;&#xD;
  &#xD;
            3. Have been diagnosed with keratoconus or corneal distortion;&#xD;
  &#xD;
            4. Have any known active* ocular condition, disease and/or infection;&#xD;
  &#xD;
            5. Have a systemic or ocular condition that in the opinion of the investigator may affect&#xD;
               a study outcome variable e.g. pingueculae;&#xD;
  &#xD;
            6. Are using any systemic or topical medications that in the opinion of the investigator&#xD;
               may affect a study outcome variable;&#xD;
  &#xD;
            7. Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either&#xD;
               corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#;&#xD;
  &#xD;
            8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;&#xD;
  &#xD;
            9. Are pregnant, lactating or planning a pregnancy^ at the time of enrolment, by self&#xD;
               report;&#xD;
  &#xD;
           10. Have undergone refractive error surgery;&#xD;
  &#xD;
           11. Are listed on the Delegation Log for this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lyndon Jones, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Director, Centre for Ocular Research and Education</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jose Vega, OD, MSc, PhD</last_name>
      <phone>925-621-3761</phone>
      <email>jvega2@coopervision.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>School of Optometry &amp; Vision Sciences</name>
        <address>
          <city>Waterloo</city>
          <state>Ontario</state>
          <zip>N2L 3G1</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</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/NCT05973409
  org study id: SEC-P052021
  nct id: NCT05973409
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study is being conducted to determine if scleral lenses coated with Hydra-PED improve
        comfort and dryness.
  The objective of the study is to determine if scleral lenses with and scleral lenses without
        Hydra-PEG coating provide positive improvement in ocular comfort and dryness scores.
  
        The effect of the study lenses and the coating, will be compared in a group of symptomatic
        soft lens wearers, and also in a group of symptomatic non contact lens wearers.
  
        The primary outcome variable for this study is "overall ocular comfort" reported at the
        screening visit for the habitual vision correction, and at the 4-week follow-up visits for
        each of the two study lenses. using a 0-10 scale (0.5 steps).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  masking description: At the fitting visit, only uncoated lenses will be used to determine the parameters of the lenses to be ordered. At both dispense visits, participants and investigators will be masked to the lens type dispensed. In order to achieve this, unmasked study personnel will determine the order of lens wear according to the randomization schedule and they will not share the lens labels or packs with the investigator. Instead, the lenses will be transferred to an unmarked case/container prior to being provided at the Dispense visit.
  measure: overall ocular comfort
  time frame: 4 weeks
  description: reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps)
  arm group label: Habitual Soft Lens Wearers
  arm group type: Experimental
  description: Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.
  arm group label: Non Contact Lens Wearers
  arm group type: Experimental
  description: Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.
  intervention type: Device
  intervention name: scleral lens
  description: scleral lens with and without hydra-peg coating
  arm group label: Habitual Soft Lens Wearers
  arm group label: Non Contact Lens Wearers
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lyndon Jones, PhD
  role: Principal Investigator
  affiliation: Director, Centre for Ocular Research and Education
  last name: Jose Vega, OD, MSc, PhD
  phone: 925-621-3761
  email: jvega2@coopervision.com
  facility: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca