Tear Production by Nasal Neurostimulation Compared to Active Control

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970799
• Other study ID #: OCUN-016B
• Status: Completed
• Phase: N/A
• Start date: August 31, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2021
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tear Meniscus Height		Pre and Post Application on Days 15 and 29
Other	Tear Meniscus Area		Pre and Post Application Days 15 and 29
Other	Number of Secreting Meibomian Glands		Day 1
Other	Tear Film Lipid Layer Thickness by Tearscope		Pre and Post Application on Days 15 and 29
Other	Lower Lid Margin Temperature		Pre and Post Application on Days 15 and 29
Other	Tear Film Temperature		Pre and Post Application on Days 15 and 29
Other	Number of Participants With Adverse Events		Up to 41 days
Primary	Acute Tear Production by Jones Schirmer Test		Day 1