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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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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.

0 / 9Eligibility criteria met