<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/NCT01712022</url>
  </required_header>
  <id_info>
    <org_study_id>200-48071</org_study_id>
    <nct_id>NCT01712022</nct_id>
  </id_info>
  <brief_title>Evaluation of Corneal Epithelial Thickness Mapping</brief_title>
  <official_title>Evaluation of Corneal Epithelial Thickness Mapping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optovue</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Optovue</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of&#xD;
      the study is to evaluate the accuracy and repeatability of the epithelial thickness&#xD;
      measurement. Consented subjects will undergo a series of cornea measurements using optical&#xD;
      coherence tomography (OCT) that will be used for analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>corneal epithelial thickness</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Dry Eye and Contact Lens Wear</condition>
  <arm_group>
    <arm_group_label>Dry Eye</arm_group_label>
    <description>clinical diagnosis of dry eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contact Lens</arm_group_label>
    <description>routine wear of contact lens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>Not having history of dry eye or contact lens wear or corneal pathology or surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        seeing eye doctor for routine or follow-up care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able and willing to provide consent&#xD;
&#xD;
          -  Able and willing to complete the required examinations&#xD;
&#xD;
          -  DRY EYE GROUP ONLY: Clinical diagnosis of dry eye&#xD;
&#xD;
          -  CONTACT LENS GROUP ONLY: Regular contact lens wear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular surgery&#xD;
&#xD;
          -  History of laser refractive surgery&#xD;
&#xD;
          -  History of cataract surgery&#xD;
&#xD;
          -  DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye&#xD;
&#xD;
          -  CONTACT LENS GROUP ONLY: Corneal pathology including dry eye&#xD;
&#xD;
          -  NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fishman Vision</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon-Weiss-Schanzlin Vision Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brass Eye Center</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</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>
  </condition_browse>
  <!-- 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/NCT01712022
org study id: 200-48071
nct id: NCT01712022
lead sponsor: 
has dmc: No
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of
      the study is to evaluate the accuracy and repeatability of the epithelial thickness
      measurement. Consented subjects will undergo a series of cornea measurements using optical
      coherence tomography (OCT) that will be used for analysis.
observational model: Cohort
time perspective: Prospective
measure: corneal epithelial thickness
time frame: Day 1
arm group label: Dry Eye
description: clinical diagnosis of dry eye
arm group label: Contact Lens
description: routine wear of contact lens
arm group label: Normal
description: Not having history of dry eye or contact lens wear or corneal pathology or surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes