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Funding ended
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Tears | Drug | Self-Administered - utilizing eye drop preservative free vials |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Sobel, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917111 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Geometric Mean | 95% Confidence Interval | Becquerel | Over a 4 day period |
|
Approximately 32 months and 15 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early vasovagal response | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Melton | Vanderbilt-Ingram Cancer Center | 615-936-7423 | teresa.melton@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2020 | Dec 18, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2022 | Nov 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |