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

Sponsor

Vanderbilt-Ingram Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04327999

Collaborator

(none)

Enrollment

Location

Arm

44.8

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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 obstruction.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Carcinoma Radioactive Iodine Level	Drug: Artificial Tears	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction in level of radioactive iodine in tears [about 7 days]
Radioactive iodine level will be measured using a well counter through the Nuclear medicine department

Secondary Outcome Measures

Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

Investigators

Principal Investigator: Rachel Sobel, MD, Vanderbilt Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rachel Sobel, Principal Investigator, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT04327999

Other Study ID Numbers:

VICC HN 2018

First Posted:

Mar 31, 2020

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carcinoma

Thyroid Neoplasms

Lubricant Eye Drops

Study Results

No Results Posted as of Jan 3, 2022