NCT05999630 Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
| NCT ID | NCT05999630 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Nasolacrimal Duct Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2023-08-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05999630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasolacrimal Duct Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05999630 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT05999630 currently recruiting?
Yes, NCT05999630 is actively recruiting participants. Contact the research team at marybeth.l.carter@vumc.org for enrollment information.
Where is the NCT05999630 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05999630 clinical trial?
NCT05999630 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 100 participants.