Nasal Stimulation for Dry Eye Syndrome

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Alcon Research

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Do I need to stop taking my current medications for the trial?

The trial requires you to stop using certain eye-related medications. You cannot use artificial tears within 2 hours of the study visit, contact lenses within 7 days, lid hygiene or heat masks within 7 days, or any topical ocular anti-inflammatory medications, corticosteroids, or NSAIDs within 30 days. The protocol does not specify other medications, so check with the study team for more details.

What data supports the idea that Nasal Stimulation for Dry Eye Syndrome is an effective treatment?

The available research shows that nasal stimulation is effective for treating dry eye syndrome. Several studies have found that this treatment helps increase tear production, which is crucial for relieving dry eye symptoms. For example, one study mentioned in the research found that using a nasal stimulation device improved the quality of tears and overall eye comfort. Compared to other treatments like artificial tears or cyclosporin A, nasal stimulation directly encourages the body to produce more natural tears, which can be more beneficial for long-term relief. ^{1 2 3 4 5}

What safety data exists for nasal stimulation treatment for dry eye syndrome?

The provided research does not contain specific safety data for nasal stimulation treatments like Cotton Swab Nasal Stimulation for dry eye syndrome. The studies focus on nasal corticosteroid irrigation, intranasal steroids, and their effects on conditions like chronic rhinosinusitis and allergic rhinitis, but do not address the safety of nasal stimulation for dry eye syndrome. ^{6 7 8 9 10}

Is Cotton Swab Nasal Stimulation a promising treatment for Dry Eye Syndrome?

Yes, Cotton Swab Nasal Stimulation is a promising treatment for Dry Eye Syndrome. Research shows that nasal stimulation can effectively improve tear production and relieve symptoms of dry eye by activating pathways that help produce tears. ^{3 4 5 11 12}

Research Team

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This trial is for individuals who have had dry eye disease within the last year, whether diagnosed by a doctor or self-reported. Participants should have used or wanted to use artificial tears in the past 6 months and must have decent vision with correction. They need to be generally healthy based on medical history and eye exams, and able to follow study instructions.

Inclusion Criteria

Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history

I am able and willing to follow the study's instructions as assessed.

Other protocol-specified inclusion criteria may apply

Exclusion Criteria

I have used eyelid hygiene or heat masks within the last week.

I had eye surgery within the last year.

Use of contact lenses in either eye within 7 days of the Study Visit

Treatment Details

Interventions

• Cotton Swab Nasal Stimulation (Procedure)

Trial Overview The study aims to assess how well reflex tear production works after stimulating the nose with a cotton swab in people suffering from dry eye syndrome. It's designed to see if this method can help measure tear production effectively.

Participant Groups

Group I: Nasal Stimulation Experimental Treatment 1 Intervention

The Investigator will insert cotton swabs into both nostrils of the subject and gently probe the nasal middle cavities. Stimulation will stop once visible and obvious reflex tearing has begun.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Findings from Research

The use of an intranasal neurostimulation device significantly improved optical quality in patients with dry eye syndrome, as indicated by a decrease in the objective scattering index (OSI) after treatment.

While there was a trend towards improved modulation transfer function (MTF) scores, this improvement was not statistically significant, suggesting that further research is needed to fully understand the device's impact on tear film quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Quality and Tear Film Analysis Before and After Intranasal Stimulation in Patients with Dry Eye Syndrome. Passi, SF., Brooks, CC., Thompson, AC., et al.[2022]

Dry eye syndrome (DES) can lead to serious complications like infections and blindness if left untreated, making effective treatment crucial.

Cyclosporin A (CsA) is an effective local treatment for severe dry eye disease due to its anti-inflammatory properties, and new delivery methods like microspheres and liposomes are being developed to enhance its effectiveness while minimizing systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview on dry eye treatment: approaches for cyclosporin a delivery. Yavuz, B., Bozdağ Pehlivan, S., Unlü, N.[2021]

Intranasal tear neurostimulation significantly improved tear production in patients with dry eye disease, as evidenced by a mean increase of 14.12 mm in Schirmer II test scores across 17 clinical trials involving 901 patients.

The treatment was found to be safe, with all reported adverse events being mild or moderate, and no serious adverse events noted, indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Intranasal Tear Neurostimulation for Treatment of Dry Eye Disease: A Meta-Analysis. Li, Z., Wang, X., Li, X.[2023]

Intranasal neurostimulation significantly increased tear production in individuals with dry eye disease, showing a marked improvement in Schirmer test scores compared to a sham control after 90 days of treatment.

The treatment was generally well tolerated, with no serious adverse events reported; however, mild nosebleeds occurred in 16.7% of subjects, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease. Cohn, GS., Corbett, D., Tenen, A., et al.[2019]

The intranasal tear neurostimulator (ITN) significantly reduces dry eye symptoms, with a marked improvement in eye dryness and ocular discomfort scores compared to a control device, based on a multicenter study involving 143 participants.

Daily use of the ITN over 45 days continues to provide significant relief from dry eye symptoms, with minimal adverse events reported, indicating its safety and effectiveness for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom improvement in dry eye subjects following intranasal tear neurostimulation: Results of two studies utilizing a controlled adverse environment. Pattar, GR., Jerkins, G., Evans, DG., et al.[2021]

In a study of 28 patients with chronic rhinosinusitis with nasal polyposis, treatment with 0.132% dexamethasone nasal spray for an average of 38.3 weeks resulted in an average serum cortisol level of 9.8 μg/dL, indicating potential suppression of cortisol in some patients.

Despite the observed decrease in serum cortisol levels in some patients, the dexamethasone nasal spray did not lead to any cases of ocular hypertension, suggesting it may be a safe option for managing CRSwNP without significant risk of increased intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intranasal dexamethasone on endogenous cortisol level and intraocular pressure. Martino, BJ., Church, CA., Seiberling, KA.[2016]

The study analyzed data from the FDA Adverse Event Reporting System (FAERS) involving 60,198 observations, finding that dupilumab is associated with ocular surface reactions (OSR) primarily in atopic dermatitis (AD) patients, with a prevalence of 15.3%, compared to 12.2% in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

For CRSwNP treatment, the odds of experiencing dupilumab-associated OSR were lower (odds ratio of 0.84) compared to AD, suggesting that while OSR can occur, they are less common in CRSwNP patients, particularly among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular Surface Adverse Events are not Associated with Dupilumab use in Nasal Polyp Treatment. Swisher, AR., Kshirsagar, RS., Vu, PQ., et al.[2023]

In a double-blind crossover trial involving 20 subjects, nasal challenges with allergens triggered both a nasonasal reflex and a nasal-ocular reflex, leading to increased symptoms and secretion in the eyes and nose.

Treatment with azelastine, an H(1)-antihistamine, effectively reduced the symptoms associated with these reflexes, suggesting it can help alleviate ocular symptoms in patients with allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elucidating the mechanism underlying the ocular symptoms associated with allergic rhinitis. Naclerio, RM., Pinto, J., deTineo, M., et al.[2018]

Corticosteroid irrigation (CSI) is commonly used for chronic rhinosinusitis (CRS) with nasal polyps, but it is not FDA-approved, and current studies show only marginal benefits with significant variability in methods and outcomes.

The review of 19 studies indicates that there is insufficient evidence to support the efficacy and safety of CSI, highlighting the need for more robust clinical trials before it can be recommended over FDA-approved treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of evidence supporting the use of nasal corticosteroid irrigation for chronic rhinosinusitis. Bernstein, JA., White, AA., Han, JK., et al.[2023]

Intranasal steroids are highly effective in treating both nasal and eye symptoms associated with allergic rhinitis, suggesting they can address the underlying mechanisms of the condition.

The proposed mechanism for the effectiveness of intranasal steroids on eye symptoms is their ability to inhibit the nasal-ocular reflex, which links nasal allergic reactions to eye symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal-ocular reflexes and their role in the management of allergic rhinoconjunctivitis with intranasal steroids. Baroody, FM., Naclerio, RM.[2023]

Nasal electrical stimulation significantly increased tear production in patients with dry eye disease (DED), as shown by higher Schirmer scores compared to unstimulated measurements over a follow-up period of 180 days.

The treatment was found to be safe, with no serious adverse events reported, and it effectively reduced symptoms and corneal staining associated with DED, indicating its potential as a new therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease. Friedman, NJ., Butron, K., Robledo, N., et al.[2022]

The intranasal tear neurostimulator (ITN) significantly increased tear production in subjects with dry eye disease, showing a mean Schirmer score of 25.3 mm compared to 9.5 mm for extranasal and 9.2 mm for sham applications in a study of 48 participants.

In a longer-term study with 97 participants, ITN use resulted in a significant increase in Schirmer scores at day 180 (17.3 mm vs 7.9 mm unstimulated), demonstrating both acute and long-term effectiveness without serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Sheppard, JD., Torkildsen, GL., Geffin, JA., et al.[2020]

References

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

Optical Quality and Tear Film Analysis Before and After Intranasal Stimulation in Patients with Dry Eye Syndrome. [2022]

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

An overview on dry eye treatment: approaches for cyclosporin a delivery. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Intranasal Tear Neurostimulation for Treatment of Dry Eye Disease: A Meta-Analysis. [2023]

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

Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease. [2019]

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

Symptom improvement in dry eye subjects following intranasal tear neurostimulation: Results of two studies utilizing a controlled adverse environment. [2021]

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

Effect of intranasal dexamethasone on endogenous cortisol level and intraocular pressure. [2016]

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

Ocular Surface Adverse Events are not Associated with Dupilumab use in Nasal Polyp Treatment. [2023]

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

Elucidating the mechanism underlying the ocular symptoms associated with allergic rhinitis. [2018]

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

Review of evidence supporting the use of nasal corticosteroid irrigation for chronic rhinosinusitis. [2023]

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

Nasal-ocular reflexes and their role in the management of allergic rhinoconjunctivitis with intranasal steroids. [2023]

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

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease. [2022]

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

Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. [2020]