Back to resultsIntranasal 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Withdrawn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
About this trial
This is an interventional treatment trial for Contact Allergy focused on measuring Contact Lens Discomfort
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
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
NCT ID
NCT04240587
First Posted
January 21, 2020
Last Updated
November 3, 2021
Sponsor
Tufts Medical Center
Collaborators
Coopervision, Inc.
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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