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

Thyroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04327999
• Other study ID #: VICC HN 2018
• Status: Terminated
• Phase: Phase 2
• Start date: October 5, 2020
• Est. completion date: September 25, 2023

Study information

• Verified date: January 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 obstruction.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Radioactive Iodine Level
• Thyroid Carcinoma
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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