Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
NCT ID: NCT04240587
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-03-23
2021-11-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TrueTear™ intranasal neurostimulator (ITN) Active Arm
TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve.
TrueTear™ intranasal neurostimulator (ITN)
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.
TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm
TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current.
TrueTear™ intranasal neurostimulator (ITN)
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.
Interventions
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TrueTear™ intranasal neurostimulator (ITN)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Tufts Medical Center
OTHER
Responsible Party
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Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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STUDY00000080
Identifier Type: -
Identifier Source: org_study_id