Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Learn more about:
Related Clinical Trial
Three-dimensional Ultrasonography Thyroid Volume Measurement. Oral AMXT 1501 Dicaprate in Combination With IV DFMO Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule Optimising Molecular Radionuclide Therapy Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer Function Integrity of Neck Anatomy in Thyroid Surgery An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System Evaluation of a New CZT System Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain A Study Into the Effect of Seprafilm in Open Total Thyroidectomy Lenvatinib and Pembrolizumab in DTC Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer Influence of Thyroid Hormones on the Woundhealing Process ctDNA in Patients With Thyroid Nodules Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine Trial of LBH589 in Metastatic Thyroid Cancer Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma Thyroid Cancer and Sunitinib Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients Lipid Metabolic Status in Thyroid Carcinoma

Brief Title

Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Official Title

Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma

Brief Summary

      The purpose of this study is to explore whether administration of preservative free
      artificial tears will decrease the level of detectable radioiodine in the tears and
      nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and
      thus decrease the risk of developing radioactive iodine associated nasolacrimal duct

Detailed Description

      Primary Objective:

      - To assess whether use of preservative free artificial tears following radioactive iodine
      administration will lower the level of radioactive iodine in the tears of patients treated
      with radioactive iodine for thyroid carcinoma.

      Secondary Objective:

      - To evaluate whether artificial tears would be an effective preventative intervention to
      decrease the risk of developing nasolacrimal duct stenosis, which has been associated with
      radioactive iodine administration.

Study Phase

Phase 2

Study Type


Primary Outcome

Reduction in level of radioactive iodine in tears

Secondary Outcome

 Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections


Thyroid Carcinoma


Artificial Tears

Study Arms / Comparison Groups

 Preservative free artificial tears
Description:  Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 5, 2020

Completion Date

July 2024

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Radio-iodine therapy for thyroid cancer

          -  Radioiodine therapy ≥100mCi

          -  Patient wears soft contacts on both eyes

        Exclusion Criteria:

          -  Use of eye drops, other than artificial tears

          -  History of periocular trauma with tear duct involvement/lacrimal gland trauma

          -  History of lacrimal drainage disease: canaliculitis, dacryocystitis

          -  Prior radiotherapy

          -  Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)

          -  Medical conditions that predispose to NLD stenosis

               -  Sarcoid

               -  Granulomatosis with polyangiitis

               -  Chronic lymphocytic leukemia




18 Years - N/A

Accepts Healthy Volunteers



Rachel Sobel, MD, 800-811-8480, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

VICC HN 2018

Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt-Ingram Cancer Center

Study Sponsor

Rachel Sobel, MD, Principal Investigator, Vanderbilt Medical Center

Verification Date

December 2021