<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/NCT03804502</url>
  </required_header>
  <id_info>
    <org_study_id>06215</org_study_id>
    <nct_id>NCT03804502</nct_id>
  </id_info>
  <brief_title>Pilot Study of TearCare System - Long-Term Extension</brief_title>
  <official_title>Pilot Study of TearCare System - Long-Term Extension</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the long-term clinical utility, safety, and&#xD;
      effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye&#xD;
      syndrome who had previously been treated with the TearCare System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear Break-Up Time</measure>
    <time_frame>1 month</time_frame>
    <description>Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Meibomian Gland Secretion Score</measure>
    <time_frame>1 month</time_frame>
    <description>This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPEED II Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSDI Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal staining</measure>
    <time_frame>1 month</time_frame>
    <description>This measures the degree of staining on the surface of the cornea using the NEI scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival staining</measure>
    <time_frame>1 month</time_frame>
    <description>This measures the degree of staining on the surface of the conjunctival using the NEI scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 month</time_frame>
    <description>All device-related and ocular adverse events will be collected.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>TearCare</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one TearCare treatment at the baseline visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TearCare</intervention_name>
    <description>The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.</description>
    <arm_group_label>TearCare</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously enrolled in the TearCare arm of the TearCare Pilot Study&#xD;
&#xD;
          -  Reports dry eye symptoms within 3 months of the baseline examination with a Standard&#xD;
             Patient Evaluation for Dryness (SPEED) score ≥ 6&#xD;
&#xD;
          -  TBUT of &lt;10 seconds in at least one eye&#xD;
&#xD;
          -  Willing to comply with the study, procedures, and follow-up&#xD;
&#xD;
          -  Willing and able to provide consent&#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</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>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 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/NCT03804502
org study id: 06215
nct id: NCT03804502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of the study is to evaluate the long-term clinical utility, safety, and
      effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye
      syndrome who had previously been treated with the TearCare System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tear Break-Up Time
time frame: 1 month
description: Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.
measure: Meibomian Gland Secretion Score
time frame: 1 month
description: This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.
measure: SPEED II Questionnaire
time frame: 1 month
description: The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.
measure: OSDI Questionnaire
time frame: 1 month
description: The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.
measure: Corneal staining
time frame: 1 month
description: This measures the degree of staining on the surface of the cornea using the NEI scale.
measure: Conjunctival staining
time frame: 1 month
description: This measures the degree of staining on the surface of the conjunctival using the NEI scale.
measure: Adverse Events
time frame: 1 month
description: All device-related and ocular adverse events will be collected.
arm group label: TearCare
arm group type: Experimental
description: Subjects will receive one TearCare treatment at the baseline visit
intervention type: Device
intervention name: TearCare
description: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
arm group label: TearCare
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