Artificial Tears for Blocked Tear Duct After Thyroid Cancer Treatment

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Vanderbilt University Medical Center

Must not be taking: Chemotherapy drugs

Disqualifiers: Eye drops, Periocular trauma, Radiotherapy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal duct obstruction has been well documented in the medical literature. Prior case reports have documented radioactive iodine detection in the tears of patients following radioiodine therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time. A recent study has shown that the administration of artificial tears decreases the level of detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid cancer. The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct obstruction in the two years following radioactive iodine treatment.

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.

What data supports the effectiveness of the treatment Artificial Tears, Preservative-Free Artificial Tears, PFATs for blocked tear duct after thyroid cancer treatment?

Research shows that preservative-free artificial tears (PFATs) can help reduce discomfort and improve eye health in conditions like dry eye disease and after eye surgeries, suggesting they might also be beneficial for blocked tear ducts after thyroid cancer treatment. ^{1 2 3 4 5}

Is it safe to use preservative-free artificial tears?

Research shows that preservative-free artificial tears are generally safe for use, causing minimal damage to the eye surface even with frequent use, and are less harmful than solutions with preservatives. ^{3 4 6 7 8}

How do artificial tears help with blocked tear ducts after thyroid cancer treatment?

Artificial tears, specifically preservative-free ones, are unique in that they may help reduce the radioactivity in tears after radioactive iodine therapy for thyroid cancer, potentially lowering the risk of blocked tear ducts. This approach is novel as there are currently no established preventive measures for this condition. ^{3 8 9 10 11}

Research Team

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Artificial Tears (Other)

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.

Participant Groups

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+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Findings from Research

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]

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 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 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]

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 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]

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 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]

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]

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 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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease. [2022]

3. Brazil 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. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Role of artificial tears with and without hyaluronic acid in controlling ocular discomfort following PRK: a randomized clinical trial. [2021]

5. Switzerland 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preservative-free artificial tear preparations. Assessment of corneal epithelial toxic effects. [2019]

7. United States 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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The efficacy of autologous serum eye drops for severe dry eye syndrome: a randomized double-blind crossover study. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Artificial Tears: A Systematic Review. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Categorization of Marketed Artificial Tear Formulations Based on Their Ingredients: A Rational Approach for Their Use. [2021]

11. United States 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. [2023]