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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Device: Intranasal Lacrimal Neurostimulator (Oculeve)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active - Device<br>The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. | Device: Intranasal Lacrimal Neurostimulator (Oculeve)<br>* Neurostimulation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulated Acute Tear Production | 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. | The stimulated and prestimulation (basal) measures were both performed at Day 180. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Visual Acuity | Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40). | Baseline and 6 months | 
| Slit Lamp Biomicroscopy | Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator. | 6 months |