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

Primary Purpose

Contact Allergy, Neuropathic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueTear™ intranasal neurostimulator (ITN)
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Allergy focused on measuring Contact Lens Discomfort

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TrueTear™ intranasal neurostimulator (ITN) Active Arm

TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.
To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.

Full Information

First Posted
January 21, 2020
Last Updated
November 3, 2021
Sponsor
Tufts Medical Center
Collaborators
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04240587
Brief Title
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Acronym
INTAC
Official Title
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in enrollment of study participants
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Allergy, Neuropathic Pain
Keywords
Contact Lens Discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TrueTear™ intranasal neurostimulator (ITN) Active Arm
Arm Type
Active Comparator
Arm Description
TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve.
Arm Title
TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm
Arm Type
Placebo Comparator
Arm Description
TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current.
Intervention Type
Device
Intervention Name(s)
TrueTear™ intranasal neurostimulator (ITN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
Time Frame
3 months
Title
To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
Time Frame
3 months
Title
To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.
Time Frame
3 months
Title
To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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