Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:10/27/2017
Start Date:June 2016
End Date:August 2016

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A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

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.

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

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
We found this trial at
2
sites
Newport Beach, California 92663
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
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Artesia, CA
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