Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Oculeve

Status

Completed

Conditions

Dry Eye Syndrome

Keratoconjunctivitis Sicca

Treatments

Device: Oculeve Intranasal Neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT02798289

OCUN-014

Details and patient eligibility

About

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.

Full description

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

Enrollment

55 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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