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

Tufts University

Status: Withdrawn

Conditions: Contact Allergy; Neuropathic Pain

Treatments: Device: TrueTear™ intranasal neurostimulator (ITN)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04240587

STUDY00000080

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

TrueTear™ intranasal neurostimulator (ITN) Active Arm

Active Comparator group

Description:

TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve.

Treatment:

Device: TrueTear™ intranasal neurostimulator (ITN)

TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm

Placebo Comparator group

Description:

TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current.

Treatment:

Device: TrueTear™ intranasal neurostimulator (ITN)