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

Primary Purpose

Thyroid Carcinoma, Radioactive Iodine Level

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Artificial Tears
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preservative free artificial tears

Arm 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.

Outcomes

Primary Outcome Measures

Reduction in level of radioactive iodine in tears
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
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.

Full Information

First Posted
March 4, 2020
Last Updated
January 25, 2023
Sponsor
Vanderbilt-Ingram Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04327999
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Radioactive Iodine Level

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preservative free artificial tears
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Artificial Tears
Intervention Description
Self-Administered - utilizing eye drop preservative free vials
Primary Outcome Measure Information:
Title
Reduction in level of radioactive iodine in tears
Description
Radioactive iodine level will be measured using a well counter through the Nuclear medicine department
Time Frame
about 7 days
Secondary Outcome Measure Information:
Title
Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Sobel, MD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org

12. IPD Sharing Statement

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

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