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

Tufts Medical Center1 site in 1 countryMarch 23, 2020

ConditionsContact Allergy Neuropathic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contact Allergy
Sponsor: Tufts Medical Center
Locations: 1
Primary Endpoint: To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 23, 2020

End Date

November 3, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tufts Medical Center

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.

Time Frame: 3 months

To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment

Time Frame: 3 months

To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment

Time Frame: 3 months

Secondary Outcomes

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)