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Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

NCT ID: NCT02798289

Last Updated: 2017-10-25

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-08-31

Brief Summary

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The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Detailed Description

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This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Conditions

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Dry Eye Syndrome Keratoconjunctivitis Sicca

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active - Device

The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.

Group Type EXPERIMENTAL

Oculeve Intranasal Neurostimulator

Intervention Type DEVICE

Neurostimulation device

Interventions

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Oculeve Intranasal Neurostimulator

Neurostimulation device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with dry eye disease
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
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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Neil Friedman, MD

Role: STUDY_DIRECTOR

Mid-Peninsula Ophthalmology Medical Group

Locations

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Sall Research Medical Center

Artesia, California, United States

Site Status

Aesthetic Eyecare Institute

Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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OCUN-014

Identifier Type: -

Identifier Source: org_study_id