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Artificial Tears for Blocked Tear Duct After Thyroid Cancer Treatment
Phase 3
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Radioiodine therapy ≥150 mCi
Radio-iodine therapy for thyroid cancer
Must not have
Prior radiotherapy
History of periocular trauma with tear duct involvement/lacrimal gland trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will study if using artificial tears after radioactive iodine therapy for thyroid cancer reduces the chance of tear duct blockage.
Who is the study for?
This trial is for adults over 18 who are undergoing radio-iodine therapy for thyroid cancer with a dose of at least 150 mCi. It's not suitable for those with existing tear duct blockage, use of eye drops other than artificial tears, history of trauma or disease affecting the tear ducts, prior radiation treatments, chemotherapy drug usage, or conditions that cause narrow tear ducts.
What is being tested?
The study tests if using artificial tears after radioactive iodine treatment can prevent blocked tear ducts in thyroid cancer patients. Researchers believe that these tears might reduce inflammation and fibrosis caused by radioactivity in the nasolacrimal duct over two years.
What are the potential side effects?
Artificial tears are generally safe but may occasionally cause mild irritation or discomfort in the eyes. Since they're used to manage dryness and protect against blockages here, significant side effects are not expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received radioiodine therapy of 150 mCi or more.
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I have received radio-iodine therapy for thyroid cancer.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone radiotherapy before.
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I have had an injury near my eye that affected my tear duct.
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I have used chemotherapy drugs like 5-fluorouracil or docetaxel.
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I have had infections in my tear ducts.
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I use eye drops that are not just for dry eyes.
Select...
I have a blocked tear duct.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm (Artificial Tears)Experimental Treatment1 Intervention
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)
Group II: No Intervention (No Artificial Tears)Active Control1 Intervention
Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
907 Previous Clinical Trials
934,487 Total Patients Enrolled