Trial Outcomes & Findings for Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator (NCT NCT02798289)
NCT ID: NCT02798289
Last Updated: 2017-10-25
Results Overview
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Day 1
Results posted on
2017-10-25
Participant Flow
Participant milestones
| Measure |
Active - Device
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Baseline characteristics by cohort
| Measure |
Active - Device
n=55 Participants
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population included all subjects who received device intervention.
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Outcome measures
| Measure |
Active - Device
n=55 Participants
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
|
|---|---|
|
Tear Meniscus Height Captured by Optical Coherence Tomography
Pre-stimulation TMH
|
238.4 µm
Standard Deviation 16.7
|
|
Tear Meniscus Height Captured by Optical Coherence Tomography
Post-stimulation TMH
|
634.9 µm
Standard Deviation 60.8
|
Adverse Events
Active - Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The data provided by this clinical trial, and all related information and any materials containing such data and information, are the exclusive property of Oculeve and are confidential to Oculeve. The investigator or other study-related personnel may not disclose to anyone or use any data, information, or materials related to this clinical trial without the express written consent of Oculeve.
- Publication restrictions are in place
Restriction type: OTHER