<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/NCT02992392</url>
  </required_header>
  <id_info>
    <org_study_id>2016-007</org_study_id>
    <nct_id>NCT02992392</nct_id>
  </id_info>
  <brief_title>Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome</brief_title>
  <official_title>Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been&#xD;
      developed in which phospholipid liposomes are delivered to the tear film via the surface of&#xD;
      the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte&#xD;
      application on the lipid and stability of the tear film in dry eye patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>scale of Schirmer I test</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>scale of corneal fluorescein staining</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>scale of noninvasive tear breakup time</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>scale of tear meniscus height</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>lipid layer grade</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>questionnaire of ocular surface disease index</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective comfort</measure>
    <time_frame>up to 3 months after tear substitutes apply</time_frame>
    <description>Subjective comfort was established at each time-point by asking subjects, firstly, to relate their comfort to baseline in each eye (more comfortable/no different/less comfortable) . secondly, to express a preference for their more comfortable eye (right eye/left eye/no difference)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Liposic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liposic was applied to one eye of patients in this group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tears Naturale Forte</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tears Naturale Forte was applied to one eye of patients in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liposic</intervention_name>
    <description>one eye of the participant recieved Lipoic</description>
    <arm_group_label>Liposic</arm_group_label>
    <other_name>Carbomer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tears Naturale Forte</intervention_name>
    <description>the other eye of the participant recieved Tears Naturale Forte</description>
    <arm_group_label>Tears Naturale Forte</arm_group_label>
    <other_name>DEXTRAN/HYPROMELLOSE/GLYCERIN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of 20 years(range from 20 year to 25 years)&#xD;
&#xD;
          -  The value of OSDI is over 12&#xD;
&#xD;
          -  NBUT is less 5 seconds&#xD;
&#xD;
          -  Schirmer 1 test is less 10mm&#xD;
&#xD;
          -  The basical lipid layer grade is 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular&#xD;
             infection; photophobia that may cause reflex tearing or difficulty in evaluating the&#xD;
             patient's lipid layer;&#xD;
&#xD;
          -  Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale&#xD;
             Forte&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xingwu Zhong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chi Zhang, MD,PhD</last_name>
    <email>mike0946@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingwu Zhong, MD,PhD</last_name>
      <phone>+86(898)68628481</phone>
      <email>zhongxwu@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xingwu Zhong, MD PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Tear film</keyword>
  <keyword>Lipid layer</keyword>
  <keyword>Liposic</keyword>
  <keyword>Tears Naturale Forte</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dextrans</mesh_term>
  </intervention_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/NCT02992392
org study id: 2016-007
nct id: NCT02992392
lead sponsor: 
has dmc: No
With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been
      developed in which phospholipid liposomes are delivered to the tear film via the surface of
      the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte
      application on the lipid and stability of the tear film in dry eye patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: scale of Schirmer I test
time frame: up to 3 months after tear substitutes apply
measure: scale of corneal fluorescein staining
time frame: up to 3 months after tear substitutes apply
measure: scale of noninvasive tear breakup time
time frame: up to 3 months after tear substitutes apply
measure: scale of tear meniscus height
time frame: up to 3 months after tear substitutes apply
measure: lipid layer grade
time frame: up to 3 months after tear substitutes apply
measure: questionnaire of ocular surface disease index
time frame: up to 3 months after tear substitutes apply
measure: subjective comfort
time frame: up to 3 months after tear substitutes apply
description: Subjective comfort was established at each time-point by asking subjects, firstly, to relate their comfort to baseline in each eye (more comfortable/no different/less comfortable) . secondly, to express a preference for their more comfortable eye (right eye/left eye/no difference)
arm group label: Liposic
arm group type: Experimental
description: Liposic was applied to one eye of patients in this group
arm group label: Tears Naturale Forte
arm group type: Experimental
description: Tears Naturale Forte was applied to one eye of patients in this group
intervention type: Drug
intervention name: Liposic
description: one eye of the participant recieved Lipoic
arm group label: Liposic
other name: Carbomer
intervention type: Drug
intervention name: Tears Naturale Forte
description: the other eye of the participant recieved Tears Naturale Forte
arm group label: Tears Naturale Forte
other name: DEXTRAN/HYPROMELLOSE/GLYCERIN
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xingwu Zhong
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
last name: Chi Zhang, MD,PhD
email: mike0946@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xingwu Zhong, MD PhD
investigator title: Professor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Dextrans