<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/NCT03006978</url>
  </required_header>
  <id_info>
    <org_study_id>05429</org_study_id>
    <nct_id>NCT03006978</nct_id>
  </id_info>
  <brief_title>Pilot Study of the TearCare System</brief_title>
  <official_title>Pilot Study of the TearCare System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sight Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sight Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of&#xD;
      the TearCare™ System compared to standardized warm compress therapy for the application of&#xD;
      controlled, localized heat therapy in adult patients with dry eye syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear Breakup Time</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Meibomian Gland Assessment</measure>
    <time_frame>Day 1, Week 2, Week 4, 3 Month, 6 Month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dry Eye Symptoms and Quality of Life</measure>
    <time_frame>Week 2, Week 4, 3 Month, 6 Month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Use</measure>
    <time_frame>Day 1, Week 2, Week 4, 3 Month, 6 Month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>TearCare</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warm Compress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TearCare</intervention_name>
    <arm_group_label>TearCare</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Warm Compress</intervention_name>
    <arm_group_label>Warm Compress</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dry eye symptoms within 30 months of the screening exam with a SPEED score &gt;=6&#xD;
&#xD;
          -  Schirmer 1 value of &lt;010 mm in at least one eye or a Tear Breakup time &lt;10 seconds in&#xD;
             at least one eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active ocular or peri-ocular infection or inflammation&#xD;
&#xD;
          -  Recurrent eye inflammation within the past 3 months&#xD;
&#xD;
          -  Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes&#xD;
             Zoster&#xD;
&#xD;
          -  Ocular surface abnormalities that may affect tear film distribution or treatment&#xD;
&#xD;
          -  Abnormal eyelid function in either eye&#xD;
&#xD;
          -  Diminished or abnormal facial, periocular, ocular or corneal sensation&#xD;
&#xD;
          -  Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal&#xD;
             dystrophies&#xD;
&#xD;
          -  Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)&#xD;
&#xD;
          -  Allergies to silicone tissue adhesives&#xD;
&#xD;
          -  An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).&#xD;
&#xD;
          -  Unwillingness to abstain for the duration of the study from systemic medication known&#xD;
             to cause ocular dryness (e.g. Accutane, antihistamines, etc.)&#xD;
&#xD;
          -  Anyone who requires chronic use (i.e. for any portion of the study) of topical&#xD;
             ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who&#xD;
             has been on any of these medications within the past 30 days.&#xD;
&#xD;
          -  Unwillingness to washout and remain off certain dry eye medications for the duration&#xD;
             of the study.&#xD;
&#xD;
          -  Participation in another ophthalmic clinical trial within the past 30 days&#xD;
&#xD;
          -  Co-existing conditions that could interfere with the assessment of safety or efficacy&#xD;
             of treatment (e.g. macular disease, pregnancy, nursing, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Central Eye Care, Ltd.</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</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/NCT03006978
org study id: 05429
nct id: NCT03006978
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of
      the TearCare™ System compared to standardized warm compress therapy for the application of
      controlled, localized heat therapy in adult patients with dry eye syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tear Breakup Time
time frame: 4 weeks
measure: Meibomian Gland Assessment
time frame: Day 1, Week 2, Week 4, 3 Month, 6 Month
measure: Dry Eye Symptoms and Quality of Life
time frame: Week 2, Week 4, 3 Month, 6 Month
measure: Change in Medication Use
time frame: Day 1, Week 2, Week 4, 3 Month, 6 Month
measure: Adverse Events
time frame: Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month
arm group label: TearCare
arm group type: Experimental
description: Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
arm group label: Warm Compress
arm group type: Active Comparator
description: Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
intervention type: Device
intervention name: TearCare
arm group label: TearCare
intervention type: Device
intervention name: Warm Compress
arm group label: Warm Compress
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
sharing ipd: No