Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2023-09-25

Brief Summary

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The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

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Detailed Description

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Primary Objective:

\- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma.

Secondary Objective:

\- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Conditions

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Thyroid Carcinoma Radioactive Iodine Level

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Preservative free artificial tears

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.

Group Type EXPERIMENTAL

Artificial Tears

Intervention Type DRUG

Self-Administered - utilizing eye drop preservative free vials

Interventions

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Artificial Tears

Self-Administered - utilizing eye drop preservative free vials

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Radio-iodine therapy for thyroid cancer
* Radioiodine therapy ≥100mCi
* Patient wears soft contacts on both eyes

Exclusion Criteria

* 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

* Sarcoid
* Granulomatosis with polyangiitis
* Chronic lymphocytic leukemia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No