- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327999
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Self-Administered - utilizing eye drop preservative free vials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Level of Radioactive Iodine in Tears
Time Frame: Over a 4 day period
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections
Time Frame: 2 years
|
Patients will be monitored over time for development of nasolacrimal duct stenosis symptoms, such as epiphora or tear duct infections.
Patients will be be assessed in clinic every 8 months for 2 years after radioactive iodine.
They will asked about symptoms related to nasolacrimal duct stenosis and will also received tear duct irrigation.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rachel Sobel, MD, Vanderbilt Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC HN 2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingPoorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Squamous Cell Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8United States
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National Cancer Institute (NCI)CompletedRefractory Differentiated Thyroid Gland Carcinoma | Unresectable Thyroid Gland Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Refractory Thyroid Gland Hurthle Cell CarcinomaUnited States, Canada
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedPoorly Differentiated Thyroid Gland Carcinoma | Recurrent Differentiated Thyroid Gland Carcinoma | Columnar Cell Variant Thyroid Gland Papillary Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Metastatic Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Papillary... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingPoorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Anaplastic Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVA Thyroid Gland...United States
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National Cancer Institute (NCI)Active, not recruitingPoorly Differentiated Thyroid Gland Carcinoma | Refractory Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Differentiated Thyroid Gland Carcinoma | Thyroid... and other conditionsUnited States
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Grupo Espanol de Tumores NeuroendocrinosMFARActive, not recruitingMetastatic Thyroid Cancer | Metastatic Thyroid Papillary Carcinoma | Metastatic Thyroid Follicular CarcinomaSpain
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Gland Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Stage IV Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Follicular Carcinoma | Stage IV Thyroid Gland Follicular CarcinomaUnited States
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M.D. Anderson Cancer CenterRecruitingRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Anaplastic Carcinoma | Thyroid Gland Squamous Cell Carcinoma | Thyroid Gland Medullary Carcinoma | Thyroid Gland Papillary Carcinoma | Malignant Thyroid Gland NeoplasmUnited States
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