Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye (NCT NCT02313454)
NCT ID: NCT02313454
Last Updated: 2020-01-31
Results Overview
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.
COMPLETED
NA
21 participants
Pre-application to Post-application on Day 0
2020-01-31
Participant Flow
21 participants were enrolled. 1 participant had an adverse event (pre-existing condition), did not receive treatment and was withdrawn prior to controlled adverse environment (CAE) exposure.
Participant milestones
| Measure |
Intranasal Then Extranasal Application
Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, extranasal application (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
Extranasal Then Intranasal Application
Intranasal Tear Neurostimulator device, extranasal application (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
|---|---|---|
|
Treatment 1
STARTED
|
9
|
11
|
|
Treatment 1
COMPLETED
|
9
|
11
|
|
Treatment 1
NOT COMPLETED
|
0
|
0
|
|
Treatment 2
STARTED
|
8
|
10
|
|
Treatment 2
COMPLETED
|
8
|
10
|
|
Treatment 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-application to Post-application on Day 0Population: Per-Protocol (PP) Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results.
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Intranasal Application
n=18 Participants
Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
Extranasal Application
n=18 Participants
Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
|---|---|---|
|
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
|
-1.1 score on a scale
Standard Deviation 1.0
|
-0.4 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Pre-application to Post-application on Day 0Population: PP Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Intranasal Application
n=18 Participants
Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
Extranasal Application
n=18 Participants
Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
|
|---|---|---|
|
Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)
|
-18.7 score on a scale
Standard Deviation 26.4
|
-7.1 score on a scale
Standard Deviation 15.9
|
Adverse Events
Intranasal Application
Extranasal Application
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 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