A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Dry Eye Syndrome, Keratoconjunctivitis Sicca

In brief

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Key facts

Study ID

NCT02680158

Run by

Oculeve, Inc.

People needed

48

Starts

2016-01-31

Expected to finish

2016-03-31

Last updated by the study team

2019-04-26

Who can join

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

You may qualify if…

• Participants with aqueous tear deficiency
• 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 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
• A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Where it is running

• The Eye Care Group — Waterbury, Connecticut, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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