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

NCT04240587 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • CooperVision, Inc.

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2021-11-03
Completion
2021-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240587 on ClinicalTrials.gov