<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/NCT04442464</url>
  </required_header>
  <id_info>
    <org_study_id>18-004974</org_study_id>
    <nct_id>NCT04442464</nct_id>
  </id_info>
  <brief_title>Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear</brief_title>
  <official_title>Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if short-term wear of a spherical rigid contact&#xD;
      lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular Pressure (IOP)</measure>
    <time_frame>Baseline, every half hour for 4 hours</time_frame>
    <description>Change in intraocular pressure measured in millimeters of mercury (mm Hg)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Study Eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One eye will be randomly selected to wear the scleral lenses to be worn during study measurements</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Eye</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-lens wearing eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scleral Lens</intervention_name>
    <description>15.0 mm diagnostic spherical rigid contact lens</description>
    <arm_group_label>Study Eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of ocular hypertension (IOP &gt;22 in each eye during at least two visits over&#xD;
             the previous 3 years)&#xD;
&#xD;
          -  May have had cataract extraction and IOL&#xD;
&#xD;
          -  Not on topical medication for glaucoma&#xD;
&#xD;
          -  No History of ALT/SLT&#xD;
&#xD;
          -  Any Age, 18 years or older&#xD;
&#xD;
          -  History of contact lens wear (except scleral lenses), as long as they are willing to&#xD;
             not wear their lenses the day of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On topical medication for glaucoma&#xD;
&#xD;
          -  Eye disease&#xD;
&#xD;
          -  Inability to wear scleral lenses&#xD;
&#xD;
          -  Any intraocular surgery other than uncomplicated cataract extraction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cherie Nau, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cherie Nau, OD</last_name>
      <phone>507-284-3614</phone>
      <email>nau.cherie@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Cherie B. Nau</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Hypertension</mesh_term>
  </condition_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/NCT04442464
org study id: 18-004974
nct id: NCT04442464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if short-term wear of a spherical rigid contact
      lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Intraocular Pressure (IOP)
time frame: Baseline, every half hour for 4 hours
description: Change in intraocular pressure measured in millimeters of mercury (mm Hg)
arm group label: Study Eye
arm group type: Experimental
description: One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
arm group label: Control Eye
arm group type: No Intervention
description: Non-lens wearing eye
intervention type: Device
intervention name: Scleral Lens
description: 15.0 mm diagnostic spherical rigid contact lens
arm group label: Study Eye
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cherie Nau, OD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Cherie B. Nau
investigator title: Principal Investigator
mesh term: Ocular Hypertension
sharing ipd: No