Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oculeve, Inc.
- Enrollment
- 97
- Locations
- 3
- Primary Endpoint
- Stimulated Acute Tear Production
Study Overview
Brief Summary
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.
Detailed Description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
- •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
Arms & Interventions
Active - Device
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.
Intervention: Intranasal Lacrimal Neurostimulator (Oculeve) (Device)
Outcomes
Primary Outcomes
Stimulated Acute Tear Production
Time Frame: The stimulated and prestimulation (basal) measures were both performed at Day 180.
Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.
Secondary Outcomes
- Corrected Distance Visual Acuity(Baseline and 6 months)
- Slit Lamp Biomicroscopy(6 months)