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

Oculeve

Status: Completed

Conditions: Dry Eye Syndrome; Keratoconjunctivitis Sicca

Treatments: Device: Sham; Device: Oculeve Extranasal; Device: Oculeve Intranasal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02680158

OCUN-009

Details and patient eligibility

About

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.

Full description

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Enrollment: 48 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 6 patient groups

Sequence 1-Intranasal: Extranasal: Sham

Experimental group

Description:

Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal

Sequence 2-Intranasal: Sham: Extranasal

Experimental group

Description:

Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal

Sequence 3-Extranasal: Intranasal: Sham

Experimental group

Description:

Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal

Sequence 4-Extranasal: Sham: Intranasal

Experimental group

Description:

Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal

Sequence 5-Sham: Intranasal: Extranasal

Experimental group

Description:

Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal

Sequence 6-Sham: Extranasal: Intranasal

Experimental group

Description:

Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Treatment:

Device: Oculeve Extranasal

Device: Sham

Device: Oculeve Intranasal