<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/NCT04426240</url>
  </required_header>
  <id_info>
    <org_study_id>2019-11-203</org_study_id>
    <nct_id>NCT04426240</nct_id>
  </id_info>
  <brief_title>The Effect of Cyclosporin Before Cataract Surgery</brief_title>
  <official_title>A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of&#xD;
      post cataract surgery dry eye syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">January 26, 2022</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal florescence staining score</measure>
    <time_frame>1 month</time_frame>
    <description>Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tear break-up time</measure>
    <time_frame>1 month</time_frame>
    <description>Time to break tear film</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer test</measure>
    <time_frame>1 montn</time_frame>
    <description>Tear secretion test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>Cyclosporine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-Cyclosporine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subject who use only hyaluronate eye drop 1 month before cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine microemulsion</intervention_name>
    <description>Intervention group receives topical cyclosporine dry eye treatment before cataract surgery</description>
    <arm_group_label>Cyclosporine</arm_group_label>
    <other_name>Cyporin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 21+ adult men and women&#xD;
&#xD;
          2. Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract&#xD;
&#xD;
          3. Corneal fluorescein staining score (Oxford) is II or less&#xD;
&#xD;
          4. Preoperative MMP-9 positive&#xD;
&#xD;
          5. Those who have not used the trial and the test (cyclosporine) for at least 1 month&#xD;
             before surgery.&#xD;
&#xD;
          6. Those who have voluntarily written consent to participate in this clinical trial&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Those who have used systemic or topical cyclosporine within 4 weeks&#xD;
&#xD;
          2. Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation /&#xD;
             infection, etc.) other than the current dry eye syndromes&#xD;
&#xD;
          3. Patients who have systemic or ocular disorders or conditions (eye surgery, trauma,&#xD;
             disease) that can influence the results of this trial.&#xD;
&#xD;
          4. Abnormal eyelid function&#xD;
&#xD;
          5. An eye disease that can impair the function of the corneal sensation: herpes&#xD;
             keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium,&#xD;
             pinguecula, diabetic keratitis, keratoconus , corneal transplant status&#xD;
&#xD;
          6. Patients with active eye infections&#xD;
&#xD;
          7. Patients with conflicts with this clinical trial&#xD;
&#xD;
          8. Pregnant and lactating mothers&#xD;
&#xD;
          9. Patients who are determined to be inappropriate by other investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tae-Young Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>tae-young chung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <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>Cyclosporine</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/NCT04426240
org study id: 2019-11-203
nct id: NCT04426240
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of
      post cataract surgery dry eye syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Corneal florescence staining score
time frame: 1 month
description: Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points.
measure: tear break-up time
time frame: 1 month
description: Time to break tear film
measure: Schirmer test
time frame: 1 montn
description: Tear secretion test
arm group label: Cyclosporine
arm group type: Active Comparator
description: Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery
arm group label: non-Cyclosporine
arm group type: No Intervention
description: Subject who use only hyaluronate eye drop 1 month before cataract surgery
intervention type: Drug
intervention name: Cyclosporine microemulsion
description: Intervention group receives topical cyclosporine dry eye treatment before cataract surgery
arm group label: Cyclosporine
other name: Cyporin
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Tae-Young Chung
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: tae-young chung
investigator title: Professor
mesh term: Cataract
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Cyclosporine
mesh term: Cyclosporins