Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome (NCT NCT02680158)
NCT ID: NCT02680158
Last Updated: 2019-04-26
Results Overview
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
COMPLETED
NA
48 participants
Day 0 post-application
2019-04-26
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Sequence 1 - Intranasal : Extranasal : Sham
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
Sequence 2 - Intranasal : Sham : Extranasal
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
Sequence 3 - Extranasal: Intranasal: Sham
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
Sequence 4 - Extranasal : Sham : Intranasal
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
Sequence 5 - Sham : Intranasal : Extranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
Sequence 6 - Sham : Extranasal : Intranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8 8
|
8 8
|
8 8
|
8 8
|
8 8
|
8 8
|
|
Overall Study
COMPLETED
|
8 8
|
8 8
|
8 8
|
8 8
|
8 8
|
8 8
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=48 eyes
All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0.
|
|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 post-applicationPopulation: The FAS population included all randomized participants who were exposed to study application.
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Outcome measures
| Measure |
Oculeve Intranasal
n=48 eyes
Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0
|
Sham
n=48 eyes
Sham device (control), intranasal application for approximately 3 minutes on Day 0
|
Oculeve Extranasal
n=48 eyes
Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
|
|---|---|---|---|
|
Acute Stimulated Tear Production
|
25.3 mm
Standard Deviation 10.70
|
9.2 mm
Standard Deviation 7.34
|
9.5 mm
Standard Deviation 8.15
|
PRIMARY outcome
Timeframe: Day 0Population: Safety population included all randomized participants who were exposed to study application.
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Outcome measures
| Measure |
Oculeve Intranasal
n=48 eyes
Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0
|
Sham
n=48 eyes
Sham device (control), intranasal application for approximately 3 minutes on Day 0
|
Oculeve Extranasal
n=48 eyes
Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
|
|---|---|---|---|
|
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Device-related AEs (Ocular)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Device-related AEs (Non-ocular)
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-DayOutcome measures
Outcome data not reported
Adverse Events
Oculeve Intranasal
Sham
Oculeve Extranasal
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oculeve Intranasal
n=48 participants at risk
Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0
|
Sham
n=48 participants at risk
Sham device (control), intranasal application for approximately 3 minutes on Day 0
|
Oculeve Extranasal
n=48 participants at risk
Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
|
|---|---|---|---|
|
General disorders
Exacerbation of hypertension
|
2.1%
1/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
|
General disorders
Slight transient lightheadedness
|
2.1%
1/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
|
General disorders
Intermittent nose itching
|
2.1%
1/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
|
Eye disorders
Corneal abrasion
|
2.1%
1/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
0.00%
0/48 • Day 0
Safety population included all randomized participants who were exposed to study applications.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER