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

NCT04240587 | Withdrawn FDA Device

• 1 other identifier: STUDY00000080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Allergy; Neuropathic Pain

Keywords

Contact Lens Discomfort

Outcome Measures

Primary Outcomes (3)

• 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

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

  3 months

Secondary Outcomes (2)

• To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.

  3 months

• To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.

  3 months

Study Arms (2)

TrueTear™ intranasal neurostimulator (ITN) Active Arm

ACTIVE COMPARATOR

TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve.

Device: TrueTear™ intranasal neurostimulator (ITN)

TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm

PLACEBO COMPARATOR

TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current.

Device: TrueTear™ intranasal neurostimulator (ITN)

Interventions

TrueTear™ intranasal neurostimulator (ITN) DEVICE

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) Active Arm; TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• CooperVision, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Neuralgia

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: March 23, 2020
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)