iTEAR100 Device for Dry Eye Syndrome

Overseen By Michael Gertner, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Olympic Ophthalmics, Inc.

Disqualifiers: Mental illness, Dementia, Severe agitation, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the ease and effectiveness of using a new device called iTEAR100 (a neurostimulator) with a special cover accessory to assist those with dry eye syndrome. Dry eye syndrome can cause irritation, blurry vision, and discomfort in daily life. Participants will use this device and cover to determine if it provides relief. Those already using iTEAR and NuLids treatments might find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the iTEAR100 device is safe for treating dry eye syndrome?

Research has shown that the iTEAR100 device, designed to help with dry eye syndrome, has been studied for safety and effectiveness. Previous studies found that most patients tolerated the device well. Some experienced minor side effects, such as a burning sensation at the application site, but these were uncommon. The iTEAR100 works by using energy to stimulate nerves outside the nose, helping to relieve dry eyes. Although the device is still under testing, the current phase of the trial suggests it demonstrated some safety in earlier tests, but more research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iTEAR100 device is unique because it offers a non-invasive way to stimulate tear production for those suffering from dry eye syndrome. Unlike traditional treatments like artificial tears or prescription eye drops, iTEAR100 uses a gentle mechanical stimulation method applied to the eyelids with its iLIDS100 accessory. This approach aims to provide a more natural and continuous relief by encouraging the eyes to produce their own tears, potentially reducing the need for frequent reapplication associated with conventional treatments. Researchers are excited about this innovative device as it could offer a convenient and long-lasting solution for managing dry eyes.

What evidence suggests that the iTEAR100 device is effective for dry eye syndrome?

Research has shown that the iTEAR100 device can help people with dry eye syndrome produce more tears. One study demonstrated a noticeable increase in tear production, with participants experiencing an average rise of 14.12 mm in tear volume. This increase occurs through neurostimulation, where small electrical signals gently stimulate the nerves responsible for tear production. In this trial, participants in the therapeutic iLIDS arm will use the iTEAR100 device with the iLIDS100 accessory. The device is small and easy to carry, making it convenient for daily use. These findings suggest that iTEAR100 could be a promising option for those dealing with dry eyes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This clinical trial is for individuals who are experiencing Dry Eye Syndrome or Blepharitis. The study aims to assess the usability of a new device and its disposable cover, but specific eligibility criteria have not been provided.

Inclusion Criteria

I am currently using iTEAR and NuLids.

Exclusion Criteria

Have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the iTEAR100 device with the iLIDS100 accessory for usability evaluation

4 weeks

Participants maintain their same treatment regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iTEAR100

Trial Overview The trial is testing the iTEAR100 generation 2 device with an added component called iLIDS100. This combination is designed for eyelid cleaning (microblepharoexfoliation) and nerve stimulation to potentially help with eye conditions.

How Is the Trial Designed?

Group I: Therapeutic iLIDS arm Experimental Treatment 1 Intervention

Subjects apply iTEAR100 device with iLIDS100 accessory

Who Is Running the Clinical Trial?

Olympic Ophthalmics, Inc.

Lead Sponsor

Trials

4

Recruited

370+

Published Research Related to This Trial

The Rexon-Eye device, using Quantum Molecular Resonance electrotherapy, significantly improved symptoms and clinical signs of mixed-type dry eye disease in 18 patients over 4 weeks, with notable improvements in subjective assessments and objective measures like tear break-up time and meibomian gland function.

No adverse events were reported, indicating that the treatment is safe, and it effectively reduced inflammation markers, suggesting a potential mechanism for its therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. Trivli, A., Karmiris, E., Dalianis, G., et al.[2023]

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]

The intranasal tear neurostimulator (ITN), approved in April 2017, has shown promising results in increasing tear production and improving symptoms of dry eye disease (DED) based on multiple pilot studies and randomized controlled trials.

The ITN is a noninvasive device that not only enhances aqueous tear volume but may also positively affect the composition of tears, including mucin and lipid levels, indicating its potential as a new treatment option for DED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurostimulation for tear production. Park, JK., Cremers, S., Kossler, AL.[2019]

The iTEAR device, a portable sonic neuromodulation tool, significantly improved tear production and symptoms in patients with dry eye disease, with a notable increase in the Schirmer index and a reduction in Ocular Surface Disease Index scores after 30 days of use.

The study involved 101 participants and demonstrated both safety and efficacy, with only two mild adverse events reported, indicating that iTEAR could be a viable treatment option for dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Extranasal Tear Stimulation: Pivotal Study Results. Ji, MH., Moshfeghi, DM., Periman, L., et al.[2022]

Transdermal electrical stimulation (TdES) has previously shown safety and efficacy in improving visual functions in patients with retinitis pigmentosa, with no adverse events reported during follow-up.

A new clinical trial is set to compare the effectiveness of TdES against a sham treatment in 50 patients over 24 weeks, focusing on changes in visual acuity and other visual function metrics, ensuring rigorous ethical standards and oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy and safety of transdermal electrical stimulation on the visual functions of patients with retinitis pigmentosa: a clinical trial protocol for a prospective, multicentre, randomised, double-masked and sham-controlled design (ePICO trial). Miura, G., Ozawa, Y., Shiko, Y., et al.[2022]

The FDA has classified the intranasal electrostimulation device for treating dry eye symptoms as a class II device, indicating it meets specific safety and effectiveness standards.

This classification aims to enhance patient access to innovative treatments while also reducing regulatory burdens for manufacturers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms. Final order. [2018]

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 54 patients with severe dry eye syndrome, the SmartPlug showed significant long-term efficacy, with 60.4% of patients reporting decreased use of lubricant eye drops and 75.8% experiencing symptom improvement after an average follow-up of 13 months.

While the SmartPlug is effective, there are potential complications, including canaliculitis in 6.6% of cases, highlighting the need for long-term monitoring of patients after insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SmartPlug in the management of severe dry eye syndrome. Chen, SX., Lee, GA.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06525961

iTear Single-center, Open-label, Single-arm Study This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7683850/

Novel Extranasal Tear Stimulation: Pivotal Study Results To evaluate the efficacy and safety of iTEAR, a novel, portable, sonic external neuromodulation device, for the treatment of dry eye disease (DED).

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN190026.pdf

iTEAR100 Neurostimulator - accessdata.fda.gov All 4 subjects' vision returned to baseline during the follow-up period. The investigators believed that the alterations in vision were due to temporary ...

4. withpower.com withpower.com/trial/phase-1-dry-eye-syndromes-2024-7100d

iTEAR100 Device for Dry Eye Syndrome Intranasal tear neurostimulation significantly improved tear production in patients with dry eye disease, as evidenced by a mean increase of 14.12 mm in ...

5. olympicophthalmics.com olympicophthalmics.com/clinical-data/press-releases/

Press Releases Dry Eye: The Nose Knows. Learn how neurostimulation is becoming a viable treatment option for patients who have exhausted their options.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC467035/

Efficacy and safety of trigeminal parasympathetic pathway ... This study aimed to investigate the efficacy and safety of trigeminal parasympathetic pathway (TPP) stimulation in the treatment of dry eye.

7. olympicophthalmics.com olympicophthalmics.com/itear-100/

iTEAR®100 iTEAR®100 is a patented technology that uses focused oscillatory energy designed to activate only the external nasal nerve from the outside of your nose.

8. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S465143

Tolerability of Current Treatments for Dry Eye Disease An open-label phase 4 study found similar safety events, with the most commonly reported ocular AEs including instillation-site burn (3/40 [7.5%]), instillation ...