Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240587
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Coopervision, Inc.
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Contact Allergy Neuropathic Pain Device: TrueTear™ intranasal neurostimulator (ITN) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: 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.
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.

Placebo Comparator: TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm
TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current.
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.




Primary Outcome Measures :
  1. To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment [ Time Frame: 3 months ]
  2. To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment [ Time Frame: 3 months ]
  3. To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment. [ Time Frame: 3 months ]
  2. To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit. [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240587


Locations
Layout table for location information
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Coopervision, Inc.
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04240587    
Other Study ID Numbers: STUDY00000080
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tufts Medical Center:
Contact Lens Discomfort
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Dermatitis, Allergic Contact
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dermatitis, Contact
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases