Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

Completed · Not applicable

Conditions studied: Dry Eye Syndromes, Keratoconjunctivitis Sicca

In brief

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Key facts

Study ID

NCT02526290

Run by

Oculeve, Inc.

People needed

97

Starts

2015-08-31

Expected to finish

2016-04-30

Last updated by the study team

2017-10-31

Who can join

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

You may qualify if…

• Subjects with moderate to severe 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
• Diagnosis of epilepsy
• 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

• Cornea & Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Total Eye Care — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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