Clinical trial NCT04240587: Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Official title: Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contact Allergy
Neuropathic Pain
Keywords: Contact Lens Discomfort
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: CooperVision, Inc.
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
timeFrame: 3 months
measure: To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
timeFrame: 3 months
measure: To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
timeFrame: 3 months
Secondary outcomes:
measure: To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.
timeFrame: 3 months
measure: To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: