<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/NCT03769324</url>
  </required_header>
  <id_info>
    <org_study_id>IPCT201810</org_study_id>
    <nct_id>NCT03769324</nct_id>
  </id_info>
  <brief_title>Validation of Osmolarity System: Clinical Usability Study</brief_title>
  <official_title>Validation of Osmolarity System: Clinical Usability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I-MED Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I-MED Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      Confirmatory trial to validate usability of a new portable osmolarity testing device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing&#xD;
      device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2019</start_date>
  <completion_date type="Anticipated">February 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2019</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>Osmolarity Level</measure>
    <time_frame>Baseline</time_frame>
    <description>Osmolarity Level</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Normal Eye Group</arm_group_label>
    <description>Normal eye receiving Osmolarity Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DED Group</arm_group_label>
    <description>Dry Eye Disease receiving Osmolarity Test</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Osmolarity Test</intervention_name>
    <description>Osmolarity Test</description>
    <arm_group_label>DED Group</arm_group_label>
    <arm_group_label>Normal Eye Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Dry Eye Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ocular pathology (other than Dry Eye)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilan Hofmann, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>I-MED Pharma, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilan Hofmann, PhD</last_name>
    <phone>514-758-9998</phone>
    <email>ilan@imedpharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omid Khodai, OD</last_name>
    <phone>949-735-4727</phone>
    <email>omid@drkhodai.com</email>
  </overall_contact_backup>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</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>
  <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/NCT03769324
org study id: IPCT201810
nct id: NCT03769324
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Confirmatory trial to validate usability of a new portable osmolarity testing device.
Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing
      device.
observational model: Cohort
time perspective: Prospective
measure: Osmolarity Level
time frame: Baseline
description: Osmolarity Level
arm group label: Normal Eye Group
description: Normal eye receiving Osmolarity Test
arm group label: DED Group
description: Dry Eye Disease receiving Osmolarity Test
intervention type: Diagnostic Test
intervention name: Osmolarity Test
description: Osmolarity Test
arm group label: DED Group
arm group label: Normal Eye Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ilan Hofmann, PhD
role: Study Chair
affiliation: I-MED Pharma, Inc.
last name: Ilan Hofmann, PhD
phone: 514-758-9998
email: ilan@imedpharma.com
last name: Omid Khodai, OD
phone: 949-735-4727
email: omid@drkhodai.com
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
sharing ipd: No