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Tear Production by Nasal Neurostimulation Compared to Active Control

Primary Purpose

Dry Eye, Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Intranasal Neurostimulator

About this trial

This is an interventional other trial for Dry Eye focused on measuring Dry Eye Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Mild to severe dry eye disease
Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
Literate, able to speak English or Spanish, and able to complete questionnaires independently

Exclusion Criteria:

Previously used the Intranasal Neurostimulator at any time
Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intranasal then Extranasal Application

Extranasal then Intranasal Application

Arm Description

Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.

Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.

Outcomes

Primary Outcome Measures

Acute Tear Production by Jones Schirmer Test

Secondary Outcome Measures

Full Information

NCT ID

NCT02970799

First Posted

November 17, 2016

Last Updated

September 22, 2021

Sponsor

Oculeve, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02970799

Brief Title

Tear Production by Nasal Neurostimulation Compared to Active Control

Official Title

Randomized, Controlled, Crossover Study Comparing Tear Production by Nasal Neurostimulation Versus Active Control

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2016 (Actual)

Primary Completion Date

October 31, 2016 (Actual)

Study Completion Date

October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oculeve, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

Detailed Description

In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye, Dry Eye Syndromes, Keratoconjunctivitis Sicca

Keywords

Dry Eye Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal then Extranasal Application

Arm Type

Experimental

Arm Description

Arm Title

Extranasal then Intranasal Application

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Intranasal Neurostimulator

Intervention Description

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Primary Outcome Measure Information:

Title

Acute Tear Production by Jones Schirmer Test

Time Frame

Day 1

Other Pre-specified Outcome Measures:

Title

Tear Meniscus Height

Time Frame

Pre and Post Application on Days 15 and 29

Title

Tear Meniscus Area

Time Frame

Pre and Post Application Days 15 and 29

Title

Number of Secreting Meibomian Glands

Time Frame

Day 1

Title

Tear Film Lipid Layer Thickness by Tearscope

Time Frame

Pre and Post Application on Days 15 and 29

Title

Lower Lid Margin Temperature

Time Frame

Pre and Post Application on Days 15 and 29

Title

Tear Film Temperature

Time Frame

Pre and Post Application on Days 15 and 29

Title

Number of Participants With Adverse Events

Time Frame

Up to 41 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mild to severe dry eye disease Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study Literate, able to speak English or Spanish, and able to complete questionnaires independently Exclusion Criteria: Previously used the Intranasal Neurostimulator at any time Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Torkildsen, MD

Organizational Affiliation

Andover Eye Associates

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Tear Production by Nasal Neurostimulation Compared to Active Control

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