Dry Eye, Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye Disease
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.
Interventions
DEVICEIntranasal Neurostimulator
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Sponsors
Oculeve, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Tear Production by Jones Schirmer Test | Day 1 |
Other
| Measure | Time frame |
|---|---|
| Tear Meniscus Area | Pre and Post Application Days 15 and 29 |
| Number of Secreting Meibomian Glands | Day 1 |
| Tear Film Lipid Layer Thickness by Tearscope | Pre and Post Application on Days 15 and 29 |
| Tear Meniscus Height | Pre and Post Application on Days 15 and 29 |
| Tear Film Temperature | Pre and Post Application on Days 15 and 29 |
| Number of Participants With Adverse Events | Up to 41 days |
| Lower Lid Margin Temperature | Pre and Post Application on Days 15 and 29 |
Participant flow
Pre-assignment details
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Then Extranasal Application 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. | 0 |
| Extranasal Then Intranasal Application Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Acute Tear Production by Jones Schirmer Test
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Lower Lid Margin Temperature
Time frame: Pre and Post Application on Days 15 and 29
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Number of Participants With Adverse Events
Time frame: Up to 41 days
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Number of Secreting Meibomian Glands
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Tear Film Lipid Layer Thickness by Tearscope
Time frame: Pre and Post Application on Days 15 and 29
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Tear Film Temperature
Time frame: Pre and Post Application on Days 15 and 29
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Tear Meniscus Area
Time frame: Pre and Post Application Days 15 and 29
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Tear Meniscus Height
Time frame: Pre and Post Application on Days 15 and 29
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.