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Artificial Tears for Radioactive Iodine Treatment in Thyroid Cancer
Phase 2
Waitlist Available
Led By Rachel Sobel, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test whether using artificial tears without preservatives will lower the level of radioactivity in patients' tears and decrease the chance of developing a blockage in the tear ducts.
Who is the study for?
This trial is for thyroid cancer patients undergoing radioiodine therapy of at least 100mCi and who wear soft contact lenses. It's not for those using other eye drops, with a history of tear duct trauma or disease, prior radiation treatment, chemotherapy use, or conditions like Sarcoid that lead to narrow tear ducts.Check my eligibility
What is being tested?
The study tests if preservative-free artificial tears can reduce the level of radioiodine in the nasolacrimal duct system after radioiodine therapy for thyroid cancer, potentially lowering the risk of blockages caused by radioactive iodine.See study design
What are the potential side effects?
While specific side effects are not listed for artificial tears, they are generally considered safe. However, participants should be aware of potential mild irritation or discomfort in the eyes upon application.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Level of Radioactive Iodine in Tears
Secondary outcome measures
Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections
Trial Design
1Treatment groups
Experimental Treatment
Group I: Preservative free artificial tearsExperimental Treatment1 Intervention
Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artificial Tears
2016
Completed Phase 4
~640
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,924 Total Patients Enrolled
Rachel Sobel, MD4.25 ReviewsPrincipal Investigator - Vanderbilt Medical Center
Vanderbilt-Ingram Cancer Center
5Patient Review
She is one of the most excellent physicians I have encountered and I would HIGHLY recommend her.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You wear soft contact lenses on both eyes.You are not using any eye drops except for artificial tears.You have had an injury around your eye that affected your tear duct or lacrimal gland.You have a history of problems with tear drainage, like canaliculitis or dacryocystitis.You have had radiation treatment in the past.You have had radio-iodine therapy for thyroid cancer.You have used or are currently using certain chemotherapy drugs like 5-fluorouracil or docetaxel.You have certain medical conditions that can lead to narrowing of the bile ducts.You have received a specific type of radiation therapy called radioiodine therapy at a high dose.
Research Study Groups:
This trial has the following groups:- Group 1: Preservative free artificial tears
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA endorse Artificial Tears as an acceptable treatment?
"Based on the Phase 2 trial results, which indicate some safety is established but no efficacy data exists yet, Artificial Tears received a score of 2."
Answered by AI
What is the enrollment size of this clinical investigation?
"Affirmative. As per data hosted on clinicaltrials.gov, this medical experiment is actively enrolling participants and was initially posted on October 5th 2020. The trial seeks to recruit 15 individuals from a single location, with the details last updated in December 2021."
Answered by AI
Is enrollment still open for participants in this trial?
"Affirmative. Per the information on clinicaltrials.gov, this medical experiment is currently looking for participants. It was first made available to the public on October 5th 2020 and has been modified as recently as December 30 2021. A total of 15 patients are needed from one trial site."
Answered by AI
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