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

Neuropathic Pain Clinical Trial

— INTAC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04240587
• Other study ID #: STUDY00000080
• Status: Withdrawn
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: November 3, 2021

Study information

• Verified date: November 2021
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Allergy
• Dermatitis, Allergic Contact
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment		3 months
Primary	To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment		3 months
Primary	To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.		3 months
Secondary	To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.		3 months
Secondary	To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.		3 months