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

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status and phase

Terminated
Phase 2

Conditions

Radioactive Iodine Level
Thyroid Carcinoma

Treatments

Drug: Artificial Tears

Study type

Interventional

Funder types

Other

Identifiers

NCT04327999
VICC HN 2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Preservative free artificial tears
Experimental group
Description:
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:
Drug: Artificial Tears

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Vanderbilt-Ingram Service for Timely Access

Data sourced from clinicaltrials.gov

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