Nasolacrimal Duct ObstructionPhase 3NCT05999630
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
A Phase 3 study testing Artificial Tears Methylcellulose in people with Nasolacrimal Duct Obstruction and Thyroid Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolacrimal Duct Obstruction, Thyroid Cancer
- What is being tested?
- Artificial Tears Methylcellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Radio-iodine therapy for thyroid cancer
- Radioiodine therapy ≥150 mCi
- Age 18 or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rachel Sobel, MD, 4152796578, rachel.k.sobel@vumc.org
Marybeth Carter, 615-936-1639, marybeth.l.carter@vumc.org
About this study
Official title: The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer
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
- Being tested
- Artificial Tears Methylcellulose
- Keywords
- Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer
- Medical subject headings
- Lacrimal Duct Obstruction, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Tears MethylcelluloseDrug
Participants will self-administer the artificial tears according to the schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start21 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Sobel, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999630
- Sponsor's protocol ID
- 230845
- Status last verified
- Nov 2026
- First submitted
- 13 Aug 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05999630
- Acronym / sponsor ID
- 230845
- Conditions
- Nasolacrimal Duct Obstruction, Thyroid Cancer
- Keywords
- Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (Artificial Tears) | Experimental | Drug: Artificial Tears MethylcelluloseParticipants 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 Artificial Tears) | No intervention | –Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radio-iodine therapy for thyroid cancer
- Radioiodine therapy ≥150 mCi
- Age 18 or older
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Tears MethylcelluloseParticipants will self-administer the artificial tears according to the schedule. | Drug | Experimental Arm (Artificial Tears) |
Primary outcome
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
Time frame: 2 years
The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artificial Tears Methylcellulose in people with Nasolacrimal Duct Obstruction and Thyroid Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marybeth Carter (615-936-1639, marybeth.l.carter@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.