Recruiting
Phase 3

Artificial Tears

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05999630

Conditions

Nasolacrimal Duct Obstruction

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Artificial Tears Methylcellulose

Study Details

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

Study ID

NCT05999630

Start date

Aug 21, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Radio-iodine therapy for thyroid cancer
2. Radioiodine therapy ≥150 mCi
3. Age 18 or older

Exclusion Criteria:

1. Use of eye drops, other than artificial tears
2. History of periocular trauma with tear duct involvement/lacrimal gland trauma
3. History of lacrimal drainage disease: canaliculitis, dacryocystitis
4. Prior radiotherapy
5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
7. Nasolacrimal duct obstruction at baseline

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental Arm (Artificial Tears)

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)

no intervention: No Intervention (No Artificial Tears)

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

Interventions

Artificial Tears Methylcellulose

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

Primary outcome measure

  • Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Marybeth Carter

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Rachel Sobel, MD

4152796578rachel.k.sobel@vumc.org

Marybeth Carter

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

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Nasolacrimal Duct Obstruction
  • Artificial Tears
  • Thyroid Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-10-28.