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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

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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.

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Oculeve Intranasal Lacrimal Neurostimulator Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Intranasal application of the device
Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator
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.

Active Comparator: Extranasal application of the device
Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator
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.




Primary Outcome Measures :
  1. Fluorescein tear clearance with application [ Time Frame: 1 day ]

Other Outcome Measures:
  1. Level of tear proteins pre and post administration [ Time Frame: 1 day ]
  2. Level of inflammatory mediators pre and post administration [ Time Frame: 1 day ]
  3. Goblet cell count following application [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02385292


Locations
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United States, California
Grutzmacher, Lewis & Sierra
Sacramento, California, United States, 95815
United States, Texas
Baylor College of Medicine, Department of Ophthalmology
Houston, Texas, United States, 77030
Sponsors and Collaborators
Oculeve, Inc.
Investigators
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Principal Investigator: Richard Lewis, MD Grutzmacher, Lewis & Sierra

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT02385292     History of Changes
Other Study ID Numbers: OCUN-003
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases