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WithdrawnNCT04240587INTACUpdated Nov 11, 2021

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

An interventional study of TrueTear™ intranasal neurostimulator (ITN) in Contact Allergy and Neuropathic Pain, sponsored by Tufts Medical Center. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-11-11.

Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Difficulty in enrollment of study participants
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Contact Allergy
  • Neuropathic Pain

Keywords

  • Contact Lens Discomfort
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

Browse Neuralgia studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    TrueTear™ intranasal neurostimulator (ITN) Active Arm

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

    Device: TrueTear™ intranasal neurostimulator (ITN)

  • Placebo comparator
    TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm

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

    Device: TrueTear™ intranasal neurostimulator (ITN)

Interventions

  • DeviceTrueTear™ intranasal neurostimulator (ITN)

    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.

06

What researchers measure

Primary outcomes

  1. To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment

    Time frame: 3 months

  2. To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment

    Time frame: 3 months

  3. To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.

    Time frame: 3 months

Secondary outcomes

  1. To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.

    Time frame: 3 months

  2. To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.

    Time frame: 3 months

07

Study locations

1 site
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04240587
Lead sponsor
Tufts Medical Center
Collaborators
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Jan 27, 2020
Start date
Mar 23, 2020
Primary completion
Nov 3, 2021
Completion
Nov 3, 2021
Last update
Nov 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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