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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

NCT ID: NCT02385292

Last Updated: 2021-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intranasal then Extranasal Application

Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Group Type EXPERIMENTAL

Oculeve Intranasal Lacrimal Neurostimulator

Intervention Type DEVICE

The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Extranasal then Intranasal Application

Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Group Type ACTIVE_COMPARATOR

Oculeve Intranasal Lacrimal Neurostimulator

Intervention Type DEVICE

The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Interventions

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Oculeve Intranasal Lacrimal Neurostimulator

The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oculeve, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Grutzmacher, Lewis & Sierra

Locations

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Grutzmacher, Lewis & Sierra

Sacramento, California, United States

Site Status

Baylor College of Medicine, Department of Ophthalmology

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28302532 (View on PubMed)

Other Identifiers

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OCUN-003

Identifier Type: -

Identifier Source: org_study_id