Artificial Tears for Blocked Tear Duct After Thyroid Cancer Treatment

Overseen By Marybeth Carter

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanderbilt University Medical Center

Must not be taking: Chemotherapy drugs

Disqualifiers: Eye drops, Periocular trauma, Radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether artificial tears can prevent blocked tear ducts after radioactive iodine treatment for thyroid cancer. Radioactive iodine treatment sometimes causes tear duct problems, and researchers aim to determine if artificial tears can reduce this risk. Participants will be divided into two groups: one will use artificial tears after treatment, while the other will not. This trial suits individuals who have undergone radioactive iodine therapy for thyroid cancer and do not currently use other eye drops or have a history of tear duct issues. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you do not use any eye drops other than artificial tears. Additionally, if you are currently or have previously used chemotherapy drugs like 5-fluorouracil or docetaxel, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that artificial tears are generally safe for use. People with dry eyes commonly use these eye drops, which are available without a prescription. Although they are usually well-tolerated, some individuals might experience mild side effects, such as temporary blurred vision or a slight burning sensation when first applied.

Studies have found that artificial tears can help reduce certain side effects of thyroid cancer treatment. Specifically, they can lower the amount of radioactive material in tears after radioiodine therapy, which benefits those wanting to avoid tear duct issues after such treatments.

Overall, artificial tears are considered safe for most people. However, if discomfort or unusual symptoms occur, consulting a healthcare professional is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for blocked tear ducts after thyroid cancer treatment don't focus on immediate symptom relief, but artificial tears are different because they provide rapid, localized moisture to the eye's surface. Unlike other treatments that might take longer to alleviate symptoms, artificial tears can offer quick comfort by soothing irritation and dryness right after radioactive iodine therapy. Researchers are excited because this approach could significantly improve patient comfort during the critical days following treatment, potentially setting a new standard for managing this condition effectively and swiftly.

What evidence suggests that artificial tears might be an effective treatment for blocked tear ducts after thyroid cancer treatment?

Research shows that artificial tears can help manage blocked tear ducts after thyroid cancer treatment. In this trial, participants in the experimental arm will use preservative-free artificial tears during the 4 days immediately following radioactive iodine therapy. One study found that preservative-free artificial tears reduced the amount of radioactive iodine in the tears of patients who underwent radioiodine therapy. This reduction is important because radioactive iodine in tears can cause inflammation and block tear ducts. By lowering these levels, artificial tears may help prevent blockages. This suggests that artificial tears could effectively reduce the risk of blocked tear ducts after thyroid treatment. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing radio-iodine therapy for thyroid cancer with a dose of at least 150 mCi. It's not suitable for those with existing tear duct blockage, use of eye drops other than artificial tears, history of trauma or disease affecting the tear ducts, prior radiation treatments, chemotherapy drug usage, or conditions that cause narrow tear ducts.

Inclusion Criteria

I have received radioiodine therapy of 150 mCi or more.

I have received radio-iodine therapy for thyroid cancer.

Exclusion Criteria

I have undergone radiotherapy before.

I have a condition like sarcoidosis that can lead to narrowed tear ducts.

I have had an injury near my eye that affected my tear duct.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radioactive Iodine Treatment

Participants receive radioactive iodine therapy for thyroid cancer

1 day

1 visit (in-person)

Artificial Tears Administration

Participants in the experimental arm receive artificial tears for 4 days following radioactive iodine therapy

4 days

No additional visits required

Follow-up

Participants are monitored for nasolacrimal duct obstruction over a period of 2 years

2 years

Regular follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Artificial Tears

Trial Overview The study tests if using artificial tears after radioactive iodine treatment can prevent blocked tear ducts in thyroid cancer patients. Researchers believe that these tears might reduce inflammation and fibrosis caused by radioactivity in the nasolacrimal duct over two years.

How Is the Trial Designed?

Group I: Experimental Arm (Artificial Tears) Experimental Treatment 1 Intervention

Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows: Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening)

Group II: No Intervention (No Artificial Tears) Active Control 1 Intervention

Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Artificial tears are effective in improving symptoms of dry eye disease within a month of regular use, but it may take several months for signs of improvement to appear, highlighting the importance of consistent application (about four times a day).

Combination formulations of artificial tears are generally more effective than those with a single active ingredient, with polyethylene glycol-based tears showing superior efficacy compared to carboxymethylcellulose and hydroxypropyl methylcellulose, particularly for patients with evaporative dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Tears: A Systematic Review. Semp, DA., Beeson, D., Sheppard, AL., et al.[2023]

In a study involving 16 patients with moderate-to-severe dry eye, the 0.3% hyaluronic acid artificial tear (Visaid) demonstrated significant improvements in ocular symptoms and signs compared to the 0.9% saline solution after one month of use.

Both solutions were found to be safe, with no significant differences in safety parameters, but Visaid 0.3% showed better results in the Ocular Surface Disease Index and tear breakup time, indicating its potential as a more effective treatment for dry eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease. López-de la Rosa, A., Pinto-Fraga, J., Blázquez Arauzo, F., et al.[2022]

In a study involving 16 mild dry eye patients, the artificial tear solution containing 0.2% hyaluronic acid (Visaid) significantly improved symptoms, as indicated by a 19.5% decrease in Ocular Surface Disease Index (OSDI) scores, compared to a worsening of 19.2% with 0.9% saline solution.

The use of Visaid 0.2% also led to significant improvements in ocular health markers, such as reduced corneal and conjunctival staining, and increased patient satisfaction, while showing no significant safety concerns compared to the saline solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease. Pinto-Fraga, J., López-de la Rosa, A., Blázquez Arauzo, F., et al.[2022]

In a study using scanning electron microscopy on rabbit eyes, preservative-free artificial tears (Hypotears PF and Refresh) showed normal corneal epithelial characteristics and minimal damage even with exaggerated use, indicating their safety for frequent use.

Both preservative-free artificial tear solutions caused significantly less epithelial damage compared to 0.02% benzalkonium chloride, highlighting their efficacy as safer alternatives to preserved eye drops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservative-free artificial tear preparations. Assessment of corneal epithelial toxic effects. Berdy, GJ., Abelson, MB., Smith, LM., et al.[2019]

This study reviewed various artificial tear formulations available in the U.S., categorizing them by active ingredients and highlighting the presence of biologically active excipients that help protect and mimic natural tears.

Most artificial tears use safer preservatives like purite or sodium perborate, and many are also available in preservative-free options, providing healthcare providers with a comprehensive formulary to guide treatment for dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Categorization of Marketed Artificial Tear Formulations Based on Their Ingredients: A Rational Approach for Their Use. Kathuria, A., Shamloo, K., Jhanji, V., et al.[2021]

In a study involving 30 eyes treated with 0.3% carboxymethylcellulose (CMC) tear substitute four times daily, significant improvements were observed in all clinical measures of dry eye disease, including a reduction in symptoms and enhanced tear film stability over 12 weeks.

The treatment showed high compliance at 94.3% and reported only transient adverse events, suggesting that 0.3% CMC is a safe and effective option for managing dry eye disease, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Effects of 0.3% Carboxymethylcellulose Tear Substitute Treatment on Symptoms and Signs of Dry Eye Disease in Elderly Population: A Prospective Longitudinal Study. Ballesteros-Sánchez, A., Sánchez-González, JM., Tedesco, GR., et al.[2023]

In a study of 118 cataract patients with dry eyes, the combination of artificial tears and recombinant bovine basic fibroblast growth factor significantly improved ocular surface function and reduced inflammation after surgery compared to artificial tears alone.

Patients receiving the combined treatment showed greater improvements in clinical symptoms and various ocular function tests, indicating that this approach may enhance recovery and comfort for cataract patients with dry eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the preoperative use of artificial tears combined with recombinant bovine basic fibroblast growth factor on cataract patients complicated with dry eyes. Xiao, W., Huang, P.[2023]

In a pilot study involving eight patients undergoing radioactive iodine (RAI) therapy for thyroid cancer, the use of preservative-free artificial tears (PFATs) significantly reduced the levels of 131I activity in tears by 26% on the first day and by 23% over four days, suggesting a potential preventive measure against nasolacrimal duct obstruction (NLDO).

The findings indicate that frequent administration of PFATs starting on the day of RAI ingestion may help lower the risk of NLDO, warranting further investigation in larger multi-center clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Nonrandomized Controlled Trial Examining the Use of Artificial Tears on the Radioactivity of Tears After Radioactive Iodine Treatment for Thyroid Cancer. Lee, IT., Grice, JV., Ji, X., et al.[2023]

In a study of 20 patients with severe dry eye syndrome, autologous serum (AS) eye drops significantly improved tear film stability, as indicated by a higher tear film break-up time (TBUT) compared to preservative-free artificial tears (PFAT).

Patients using AS eye drops also reported a greater reduction in symptoms, with a 55.18% decrease in Ocular Surface Disease Index (OSDI) scores, compared to a 19.50% decrease with PFAT, highlighting AS drops' superior efficacy for symptomatic relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of autologous serum eye drops for severe dry eye syndrome: a randomized double-blind crossover study. Celebi, AR., Ulusoy, C., Mirza, GE.[2022]

In a study involving 230 patients who underwent photorefractive keratectomy (PRK), the use of preservative-free artificial tears (PFAT) significantly reduced postoperative discomfort and complications compared to no treatment, with lower rates of filamentous keratitis and recurrent corneal erosion.

There was no significant difference in outcomes between PFAT with hyaluronic acid and without it, indicating that while PFAT improves recovery, adding hyaluronic acid does not provide additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of artificial tears with and without hyaluronic acid in controlling ocular discomfort following PRK: a randomized clinical trial. Mohammadpour, M., Khorrami-Nejad, M., Shakoor, D.[2021]

The study evaluated the efficacy of plasma rich in growth factors (PRGF) added to standard treatment for dry eye disease (DED) in 102 patients, showing that PRGF significantly improved symptoms and reduced ocular inflammation compared to standard treatment alone.

After 3 months, the PRGF group experienced greater reductions in ocular redness and improved tear stability, with no adverse events reported, indicating that PRGF is a safe and effective addition to DED treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Plasma Rich in Growth Factors (PRGF) Eye Drops on Ocular Redness and Symptomatology in Patients with Dry Eye Disease. Lozano-Sanroma, J., Barros, A., Alcalde, I., et al.[2023]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/thy.2023.0338

A Pilot Nonrandomized Controlled Trial Examining the Use ... Nasolacrimal duct obstruction (NLDO) is an adverse effect of high dose radioactive iodine (RAI) therapy for thyroid carcinoma.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37917111/

A Pilot Nonrandomized Controlled Trial Examining the Use ... This study assesses whether preservative free artificial tears (PFATs) can decrease the 131 I sodium iodide ( 131 I) activity in the tears of patients ...

3. withpower.com withpower.com/trial/phase-3-thyroid-neoplasms-8-2023-078ac

Artificial Tears for Blocked Tear Duct After Thyroid Cancer ... Trial Overview The study tests if using artificial tears after radioactive iodine treatment can prevent blocked tear ducts in thyroid cancer patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05999630

Artificial Tears to Prevent Nasolacrimal Duct Obstruction in ... The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of ...

5. vumc.org vumc.org/ophthalmology/oculoplastics-clinical-trials-study

Oculoplastics Clinical Trials Study This study aims to identify a potential preventative measure for decreasing the incidence of developing a blocked tear duct after radioactive iodine therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5045033/

Over the counter (OTC) artificial tear drops for dry eye syndrome Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1367048424000468

Lipid-based eye drop formulations for the management of ... These findings suggest that the medium chain triglycerides-based eye drops can effectively alleviate dry eye symptoms and improve ocular surface health, ...

8. researchgate.net researchgate.net/publication/335774641_Effectiveness_of_using_preservative-free_artificial_tears_versus_preserved_lubricants_for_the_treatment_of_dry_eyes_a_systematic_review

Effectiveness of using preservative-free artificial tears ... PDF | This systematic review aimed to assess the effectiveness of using preservative-free artificial tears versus preserved lubricants for the treatment.

9. malacards.org malacards.org/card/lacrimal_duct_obstruction

Lacrimal Duct Obstruction The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated with Radioactive Iodine for Thyroid Cancer, Recruiting ...