NCT04327999

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

March 4, 2020

Results QC Date

November 18, 2023

Last Update Submit

January 12, 2024

Conditions

Thyroid CarcinomaRadioactive Iodine Level

Outcome Measures

Primary Outcomes (1)

  • Change in Level of Radioactive Iodine in Tears

    The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.

    Over a 4 day period

Study Arms (1)

Preservative free artificial tears

EXPERIMENTAL

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.

Drug: Artificial Tears

Interventions

Artificial TearsDRUG

Self-Administered - utilizing eye drop preservative free vials

Preservative free artificial tears

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Lee IT, Grice JV, Ji X, Chen Q, Bischoff LA, Jessop AC, Barahimi B, Codere F, Mawn LA, Sobel RK. A Pilot Nonrandomized Controlled Trial Examining the Use of Artificial Tears on the Radioactivity of Tears After Radioactive Iodine Treatment for Thyroid Cancer. Thyroid. 2024 Jan;34(1):82-87. doi: 10.1089/thy.2023.0338. Epub 2023 Dec 11.

    PMID: 37917111DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Teresa Melton
Organization
Vanderbilt-Ingram Cancer Center
teresa.melton@vumc.org
615-936-7423

Study Officials

  • Rachel Sobel, MD

    Vanderbilt Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 31, 2020

Study Start

October 5, 2020

Primary Completion

September 25, 2023

Study Completion

September 25, 2023

Last Updated

January 18, 2024

Results First Posted

January 18, 2024

Record last verified: 2024-01

Locations

US(1)