Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Completed · Not applicable

Conditions studied: Dry Eye Syndrome, Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT02798289

Run by

Oculeve, Inc.

People needed

55

Starts

2016-06-01

Expected to finish

2016-08-01

Last updated by the study team

2017-10-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• Aesthetic Eyecare Institute — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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