Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)

Study Overview
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Brief Summary
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To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.

Official Title
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Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)

Conditions
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Contact Allergy, Neuropathic Pain

Intervention / Treatment
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* Device: TrueTear™ intranasal neurostimulator (ITN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years of age at screening visit Ocular Surface Disease Index (OSDI) score of less than 12 (without contact lens wear) Contact Lens Dry Eye Questionnaire (CLDEQ)-8 score of greater than 12.18 Regular contact lens wearer who wears them less than 6 hours per day due to discomfort The presence of at least one microneuroma on in vivo confocal microscopy Self-reported good compliance with healthy contact lens regimen (replace contact lenses per manufacturer's recommendations, use of multipurpose or hydrogen peroxide contact lens solution nightly) Have had an eye exam within the last two years that included dispense of a contact lens prescription Proparacaine drops relieve at least 75% of ocular symptoms to ensure that patients do not have centralized neuropathic corneal pain If a soft lens wearer, use a contact lens that was released within the last 15 years Exclusion Criteria: Use of topical drops other than artificial tear substitutes Ocular surgery or other ocular disease within 3 months prior to study enrollment Concurrent ocular disease that may impact results Have dry eye (as defined by 2 or more of the parameters below) Schirmer's wetting test < 10mm TBUT <7sec NEI scale corneal staining of 4 out of 15 at the time of enrollment Improper CL fit No microneuroma by in vivo confocal microscopy Overnight wear within 1 month of screening visit Use of colored or cosmetic lenses Contra-indication to ITN Chronic or recurrent epistaxis, coagulation disorders. Nasal or sinus surgery or significant trauma to the nose. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck. Chronic or recurrent nosebleeds Bleeding disorder Known hypersensitivity (allergy) to the hydrogel material Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device. History of migraines Under 21 years of age

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TrueTear™ intranasal neurostimulator (ITN) Active Arm<br>TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve. | Device: TrueTear™ intranasal neurostimulator (ITN)<br>* The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN active arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN sham arm will receive tips without the current.<br>|
| Placebo Comparator: TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm<br>TrueTear™ intranasal neurostimulator (ITN) with sham tips - The sham tips and do not properly carry the current. | Device: TrueTear™ intranasal neurostimulator (ITN)<br>* The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN active arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN sham arm will receive tips without the current.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment |  | 3 months | 
| To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment |  | 3 months | 
| To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment. |  | 3 months | 
| To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens Discomfort