Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer

NCT05999630 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 230845
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal duct obstruction has been well documented in the medical literature. Prior case reports have documented radioactive iodine detection in the tears of patients following radioiodine therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time. A recent study has shown that the administration of artificial tears decreases the level of detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid cancer. The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct obstruction in the two years following radioactive iodine treatment.

Conditions

Nasolacrimal Duct Obstruction; Thyroid Cancer

Keywords

Nasolacrimal Duct Obstruction; Artificial Tears; Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)

  The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.

  2 years

Study Arms (2)

Experimental Arm (Artificial Tears)

EXPERIMENTAL

Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows: Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening)

Drug: Artificial Tears Methylcellulose

No Intervention (No Artificial Tears)

NO INTERVENTION

Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.

Interventions

Artificial Tears Methylcellulose DRUG

Participants will self-administer the artificial tears according to the schedule.

Experimental Arm (Artificial Tears)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radio-iodine therapy for thyroid cancer
• Radioiodine therapy ≥150 mCi
• Age 18 or older

You may not qualify if:

• 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 (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
• Nasolacrimal duct obstruction at baseline

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Lacrimal Duct Obstruction; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Marybeth Carter

CONTACT

615-936-1639; marybeth.l.carter@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)