iTEAR100 Device for Dry Eye Syndrome

Overseen By Michael Gertner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Olympic Ophthalmics, Inc.

Disqualifiers: Mental illness, Dementia, Severe agitation, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.

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 data supports the effectiveness of the iTEAR100 treatment for Dry Eye Syndrome?

Research shows that the iTEAR100 device, which uses external neuromodulation (a technique to stimulate nerves), is effective in treating dry eye disease by improving tear production. Similar devices, like the intranasal tear neurostimulator, have also been shown to improve dry eye symptoms, suggesting that this type of treatment can be beneficial. ^{1 2 3 4 5}

Is the iTEAR100 device safe for humans?

The iTEAR100 device, also known as the intranasal tear neurostimulator, has been evaluated for safety in studies for dry eye disease. The FDA has classified it as a class II device, which means it has special controls to ensure its safety and effectiveness. ^{1 3 6 7 8}

How does the iTEAR100 treatment for dry eye syndrome differ from other treatments?

The iTEAR100 device is unique because it uses a portable, sonic external neuromodulation approach to stimulate tear production, unlike traditional treatments that may involve eye drops or medications. This method targets the nerves responsible for tear production, offering a novel way to manage dry eye symptoms. ^{1 2 3 4 6}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• iTEAR100 (Procedure)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Novel Extranasal Tear Stimulation: Pivotal Study Results. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. [2023]

3. 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]

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

Neurostimulation for tear production. [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

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

SmartPlug in the management of severe dry eye syndrome. [2018]

7. England 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). [2022]

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

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