Dry Eye Syndrome, Keratoconjunctivitis Sicca
Conditions
Brief summary
The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.
Detailed description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.
Interventions
DEVICEOculeve Intranasal Neurostimulator
Neurostimulation device
Sponsors
Oculeve, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Meniscus Height Captured by Optical Coherence Tomography | Day 1 | Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active - Device The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Active - Device |
|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Tear Meniscus Height Captured by Optical Coherence Tomography
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Time frame: Day 1
Population: Safety population included all subjects who received device intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active - Device | Tear Meniscus Height Captured by Optical Coherence Tomography | Pre-stimulation TMH | 238.4 µm | Standard Deviation 16.7 |
| Active - Device | Tear Meniscus Height Captured by Optical Coherence Tomography | Post-stimulation TMH | 634.9 µm | Standard Deviation 60.8 |