<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/NCT02229955</url>
  </required_header>
  <id_info>
    <org_study_id>HL_TSPR_302</org_study_id>
    <nct_id>NCT02229955</nct_id>
  </id_info>
  <brief_title>Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease</brief_title>
  <acronym>HL_TSPR_302</acronym>
  <official_title>A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanlim Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanlim Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic&#xD;
      solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12&#xD;
      weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety&#xD;
      in Moderate to Severe Dry Eye Disease.&#xD;
&#xD;
      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),&#xD;
      Non-anesthetic Schirmer test&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal staining test</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corneal staining test</measure>
    <time_frame>4, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular surface disease index (OSDI)</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear break up time (TBUT)</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-anesthetic Schirmer test</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival staining</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>T-sporin eye drop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restasis eye drop</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine ophthalmic solution</intervention_name>
    <description>1 drop twice/day for 12 weeks to both eyes</description>
    <arm_group_label>Restasis eye drop</arm_group_label>
    <arm_group_label>T-sporin eye drop</arm_group_label>
    <other_name>Restasis Eye Drops</other_name>
    <other_name>Tisporin Eye Drops</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        [Patients with moderate-to-severe ocular dry eye]&#xD;
&#xD;
          1. The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)&#xD;
&#xD;
          2. Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score&#xD;
             (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye,&#xD;
             Schirmer test value ≥ 3mm/5min)&#xD;
&#xD;
          3. Tear break-up time is 10 seconds or less&#xD;
&#xD;
          4. Screening both eyes, the corrected visual acuity is 0.2 or more&#xD;
&#xD;
          5. Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye&#xD;
             drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant,&#xD;
             etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Screening visits in the previous 3 months (12 weeks) who participated in the clinical&#xD;
             trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.&#xD;
&#xD;
          2. The patients with systemic or ocular disorders affected the test results (ocular&#xD;
             surgery, trauma, or disease)&#xD;
&#xD;
               1. Abnormal eyelid function : Disoders of the eyelids or eyelashes&#xD;
&#xD;
               2. Ocular allergies or currently under the treatment of allergic diseases of the eye&#xD;
                  (topical ocular mast cell stabilizer, antihistamine use, etc.)&#xD;
&#xD;
               3. Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival&#xD;
                  scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid),&#xD;
                  pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis,&#xD;
                  keratoconus, corneal transplantation&#xD;
&#xD;
          3. current or recent patients used dry eye syndrome medications (topical or systemic)&#xD;
             that may affect the status&#xD;
&#xD;
          4. The use in clinical trials of drug hypersensitivity reactions in patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The catholic university of Korea seoul st. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-Ku</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye Syndromes</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>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Cyclosporins</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/NCT02229955
org study id: HL_TSPR_302
nct id: NCT02229955
lead sponsor: 
has dmc: No
The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic
      solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12
      weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety
      in Moderate to Severe Dry Eye Disease.

      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),
      Non-anesthetic Schirmer test
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Corneal staining test
time frame: 12 weeks
measure: Corneal staining test
time frame: 4, 8 weeks
measure: Ocular surface disease index (OSDI)
time frame: 4, 8, 12 weeks
measure: Tear break up time (TBUT)
time frame: 4, 8, 12 weeks
measure: Non-anesthetic Schirmer test
time frame: 4, 8, 12 weeks
measure: Conjunctival staining
time frame: 4, 8, 12 weeks
arm group label: T-sporin eye drop
arm group type: Experimental
description: Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
arm group label: Restasis eye drop
arm group type: Active Comparator
description: Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
intervention type: Drug
intervention name: Cyclosporine ophthalmic solution
description: 1 drop twice/day for 12 weeks to both eyes
arm group label: Restasis eye drop
arm group label: T-sporin eye drop
other name: Restasis Eye Drops
other name: Tisporin Eye Drops
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Cyclosporine
mesh term: Ophthalmic Solutions
mesh term: Cyclosporins