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Trial record 1 of 10 for:    neurostimulation and tears
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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

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: NCT02385292
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 11, 2015
Last Update Posted Date April 11, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
Fluorescein tear clearance with application [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2015)
  • Level of tear proteins pre and post administration [ Time Frame: 1 day ]
  • Level of inflammatory mediators pre and post administration [ Time Frame: 1 day ]
  • Goblet cell count following application [ Time Frame: 1 day ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
Official Title  ICMJE Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
Brief Summary

The objectives of this study are:

  • To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
  • To compare the goblet cell count following application between the intranasal and extranasal applications
  • To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications
Detailed Description

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

  • Active intranasal device application
  • Active extranasal device application
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE Device: Oculeve Intranasal Lacrimal Neurostimulator
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
Study Arms  ICMJE
  • Experimental: Intranasal application of the device
    Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator
    Intervention: Device: Oculeve Intranasal Lacrimal Neurostimulator
  • Active Comparator: Extranasal application of the device
    Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator
    Intervention: Device: Oculeve Intranasal Lacrimal Neurostimulator
Publications * Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2015)
35
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Bilateral dry eyes
  • Capable of providing written informed consent

Exclusion Criteria:

  • Chronic or recurring epistaxis (nosebleeds)
  • Blood coagulation disorder
  • Uncontrolled or poorly controlled diabetes
  • Heart or pulmonary disease
  • Females who are pregnant, planning a pregnancy or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02385292
Other Study ID Numbers  ICMJE OCUN-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oculeve, Inc.
Study Sponsor  ICMJE Oculeve, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Lewis, MD Grutzmacher, Lewis & Sierra
PRS Account Oculeve, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP