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

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.

Study Overview

• Status: Withdrawn
• Conditions: Neuropathic Pain; Contact Allergy
• Intervention / Treatment: Device: TrueTear™ intranasal neurostimulator (ITN)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2020
• Primary Completion (ACTUAL): November 3, 2021
• Study Completion (ACTUAL): November 3, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Contact Lens Discomfort
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Neuralgia; Dermatitis, Allergic Contact
• Other Study ID Numbers: STUDY00000080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No