Nasal Stimulation for Dry Eye Syndrome

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Artificial tears, Topical corticosteroids

Disqualifiers: Glaucoma, Macular degeneration, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with dry eye disease by gently stimulating the inside of the nose with a cotton swab, known as Cotton Swab Nasal Stimulation. Researchers aim to determine if this simple technique can boost natural tear production. Individuals who have experienced dry eye issues in the past year and have used or considered using artificial tears may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance dry eye treatment options.

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 prior data suggests that this nasal stimulation is safe for dry eye syndrome?

Research has shown that stimulating the tear duct system safely and effectively increases tear production for people with dry eye disease. Past studies have demonstrated that methods like using a cotton swab in the nose can safely boost tear production. However, specific safety data for using cotton swabs in this manner is unavailable.

Similar methods, such as the OC-01 nasal spray, have been well-tolerated in other studies. These treatments have significantly improved dry eye symptoms without major safety issues. Although detailed safety data for the cotton swab method is lacking, positive results from similar treatments suggest it might also be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nasal stimulation for dry eye syndrome because it uses a unique approach to trigger natural tear production. Unlike standard treatments like artificial tears or medicated eye drops, this method involves gently probing the nasal cavities with a cotton swab to stimulate reflex tearing. This technique could offer a more natural, drug-free solution for dry eyes by leveraging the body's own tear production mechanisms.

What evidence suggests that nasal stimulation is effective for dry eye syndrome?

Research has shown that stimulating the inside of the nose can increase tear production in people with dry eye disease (DED). This trial will investigate the effectiveness of nasal stimulation using cotton swabs, a process known as neurostimulation, which past studies have proven safe and effective. Evidence suggests that it can quickly and lastingly improve tear production and relieve dry eye symptoms. Overall, nasal stimulation appears promising for those dealing with dry eyes. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

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

Other protocol-specified inclusion criteria may apply

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

Exclusion Criteria

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

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

Other protocol-specified exclusion criteria may apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo nasal stimulation with cotton swabs to evaluate reflex tear production

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Cotton Swab Nasal Stimulation

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.

How Is the Trial Designed?

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.

Cotton Swab Nasal Stimulation is already approved in United States for the following indications:

Approved in United States as Cotton Swab Nasal Stimulation for:

• Dry Eye Disease

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

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4862385/

A nonrandomized, open-label study to evaluate the effect of ...

Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1542012418302714

Characterization of tear production in subjects with dry eye ...

These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED).

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30472141/

Results From Two Pivotal Clinical Trials

These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED).

4.

withpower.com

withpower.com/trial/phase-dry-eye-syndrome-des-9-2024-2be1c

Nasal Stimulation for Dry Eye Syndrome · Info for Participants

Yes, Cotton Swab Nasal Stimulation is a promising treatment for Dry Eye Syndrome. Research shows that nasal stimulation can effectively improve tear production ...

5.

tandfonline.com

tandfonline.com/doi/full/10.2147/OPTH.S312108

Efficacy of an Intranasal Tear Neurostimulator in Sjögren ...

Intranasal application of the ITN device significantly increased tear production in a subset of SS patients compared to baseline and was more effective than ...

6.

journals.lww.com

journals.lww.com/corneajrnl/fulltext/2022/10000/onset_1_phase_2b_randomized_trial_to_evaluate_the.3.aspx

ONSET-1 Phase 2b Randomized Trial to Evaluate the ...

OC-01 nasal spray administered BID at 0.03 and 0.06 mg resulted in significant improvements in signs and symptoms of dry eye disease, was well tolerated,

7.

aaojournal.org

aaojournal.org/article/S0161-6420(21)00836-8/fulltext

Efficacy and Safety of OC-01 (Varenicline Solution) Nasal ...

Herein, we report the efficacy and safety outcomes of a phase 3 study (ONSET-2) investigating the efficacy and safety of OC-01 VNS (0.03 mg and 0.06 mg, ...