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

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

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 obstruction.

Study Overview

• Status: Terminated
• Conditions: Thyroid Carcinoma; Radioactive Iodine Level
• Intervention / Treatment: Drug: Artificial Tears

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Preservative free artificial tears; 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.

Drug: Artificial Tears; Self-Administered - utilizing eye drop preservative free vials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Level of Radioactive Iodine in Tears	The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.	Over a 4 day period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections	Patients will be monitored over time for development of nasolacrimal duct stenosis symptoms, such as epiphora or tear duct infections. Patients will be be assessed in clinic every 8 months for 2 years after radioactive iodine. They will asked about symptoms related to nasolacrimal duct stenosis and will also received tear duct irrigation.	2 years

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Investigators: Principal Investigator: Rachel Sobel, MD, Vanderbilt Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 28, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Carcinoma; Thyroid Neoplasms; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: VICC HN 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No