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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

Conditions
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Dry Eye Syndrome, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Device: Oculeve Intranasal
* Device: Sham
* Device: Oculeve Extranasal


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Three way cross-over study with 6 sequences.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1-Intranasal: Extranasal: Sham<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|
| Experimental: Sequence 2-Intranasal: Sham: Extranasal<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|
| Experimental: Sequence 3-Extranasal: Intranasal: Sham<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|
| Experimental: Sequence 4-Extranasal: Sham: Intranasal<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|
| Experimental: Sequence 5-Sham: Intranasal: Extranasal<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|
| Experimental: Sequence 6-Sham: Extranasal: Intranasal<br>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. | Device: Oculeve Intranasal<br>* Oculeve device, intranasal (test) application for approximately 3 minutes.<br>Device: Sham<br>* Sham device (control), intranasal application for approximately 3 minutes.<br>Device: Oculeve Extranasal<br>* Oculeve device, extranasal (control) application for approximately 3 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Stimulated Tear Production | Stimulated acute tear production in the study eye at Day 0 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 study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye. | Day 0 post-application | 
| Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular. | Day 0 |