Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Not Applicable
Withdrawn
- Conditions
- Neuropathic PainContact Allergy
- Interventions
- Device: TrueTear™ intranasal neurostimulator (ITN)
- Registration Number
- NCT04240587
- Lead Sponsor
- Tufts Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm TrueTear™ intranasal neurostimulator (ITN) TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current. TrueTear™ intranasal neurostimulator (ITN) Active Arm TrueTear™ intranasal neurostimulator (ITN) TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve.
- Primary Outcome Measures
Name Time Method To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN. 3 months 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
- Secondary Outcome Measures
Name Time Method To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit. 3 months To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment. 3 months
Trial Locations
- Locations (1)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States