xml: <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/NCT05999630</url>
    </required_header>
    <id_info>
      <org_study_id>230845</org_study_id>
      <nct_id>NCT05999630</nct_id>
    </id_info>
    <brief_title>Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer</brief_title>
    <official_title>The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vanderbilt University Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal&#xD;
        duct obstruction has been well documented in the medical literature. Prior case reports have&#xD;
        documented radioactive iodine detection in the tears of patients following radioiodine&#xD;
        therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and&#xD;
        nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time.&#xD;
        A recent study has shown that the administration of artificial tears decreases the level of&#xD;
        detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid&#xD;
        cancer. The purpose of this study will be to assess whether administering tears after&#xD;
        radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct&#xD;
        obstruction in the two years following radioactive iodine treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)</measure>
      <time_frame>2 years</time_frame>
      <description>The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Nasolacrimal Duct Obstruction</condition>
    <condition>Thyroid Cancer</condition>
    <arm_group>
      <arm_group_label>Experimental Arm (Artificial Tears)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows:&#xD;
  Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Intervention (No Artificial Tears)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Artificial Tears Methylcellulose</intervention_name>
      <description>Participants will self-administer the artificial tears according to the schedule.</description>
      <arm_group_label>Experimental Arm (Artificial Tears)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Radio-iodine therapy for thyroid cancer&#xD;
  &#xD;
            2. Radioiodine therapy ≥150 mCi&#xD;
  &#xD;
            3. Age 18 or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Use of eye drops, other than artificial tears&#xD;
  &#xD;
            2. History of periocular trauma with tear duct involvement/lacrimal gland trauma&#xD;
  &#xD;
            3. History of lacrimal drainage disease: canaliculitis, dacryocystitis&#xD;
  &#xD;
            4. Prior radiotherapy&#xD;
  &#xD;
            5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)&#xD;
  &#xD;
            6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis&#xD;
               with polyangiitis, chronic lymphocytic leukemia)&#xD;
  &#xD;
            7. Nasolacrimal duct obstruction at baseline&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marybeth Carter</last_name>
      <phone>615-936-1639</phone>
      <email>marybeth.l.carter@vumc.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Rachel Sobel</investigator_full_name>
      <investigator_title>Associate Professor of Ophthalmology</investigator_title>
    </responsible_party>
    <keyword>Nasolacrimal Duct Obstruction</keyword>
    <keyword>Artificial Tears</keyword>
    <keyword>Thyroid Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Neoplasms</mesh_term>
      <mesh_term>Lacrimal Duct Obstruction</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lubricant Eye Drops</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999630
  org study id: 230845
  nct id: NCT05999630
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal
        duct obstruction has been well documented in the medical literature. Prior case reports have
        documented radioactive iodine detection in the tears of patients following radioiodine
        therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and
        nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time.
        A recent study has shown that the administration of artificial tears decreases the level of
        detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid
        cancer. The purpose of this study will be to assess whether administering tears after
        radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct
        obstruction in the two years following radioactive iodine treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
  time frame: 2 years
  description: The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.
  arm group label: Experimental Arm (Artificial Tears)
  arm group type: Experimental
  description: Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows:
  Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening)
  arm group label: No Intervention (No Artificial Tears)
  arm group type: No Intervention
  description: Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.
  intervention type: Drug
  intervention name: Artificial Tears Methylcellulose
  description: Participants will self-administer the artificial tears according to the schedule.
  arm group label: Experimental Arm (Artificial Tears)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marybeth Carter
  phone: 615-936-1639
  email: marybeth.l.carter@vumc.org
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Rachel Sobel
  investigator title: Associate Professor of Ophthalmology
  mesh term: Thyroid Neoplasms
  mesh term: Lacrimal Duct Obstruction
  mesh term: Thyroid Diseases
  mesh term: Lubricant Eye Drops
  sharing ipd: No