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RecruitingNCT05999630Updated Nov 3, 2026

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

A Phase 3 interventional study of Artificial Tears Methylcellulose in Nasolacrimal Duct Obstruction and Thyroid Cancer, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Vanderbilt University Medical Center · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasolacrimal Duct Obstruction
  • Thyroid Cancer

Keywords

  • Nasolacrimal Duct Obstruction
  • Artificial Tears
  • Thyroid Cancer
03

In context

Lacrimal Duct Obstruction

41 studies on the registry are indexed under Lacrimal Duct Obstruction; 8 are open to participants now.

This study's planned enrollment of 100 is above the median of 75 across 30 interventional studies indexed under Lacrimal Duct Obstruction.

Browse Lacrimal Duct Obstruction studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study 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)

    Drug: Artificial Tears Methylcellulose

  • 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

  • DrugArtificial Tears Methylcellulose

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

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05999630
Responsible party
Rachel Sobel (Associate Professor of Ophthalmology, Vanderbilt University Medical Center) — Principal investigator
First posted
Aug 21, 2023
Start date
Aug 21, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Marybeth Carter
Contact
marybeth.l.carter@vumc.org
615-936-1639

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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