Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC) (NCT04240587) | Clinical Trial Compass
WithdrawnNot Applicable
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Stopped: Difficulty in enrollment of study participants
United States0Started 2020-03-23
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
Timeframe: 3 months
2
To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
Timeframe: 3 months
3
To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.