Trial Outcomes & Findings for Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation (NCT NCT02910713)
NCT ID: NCT02910713
Last Updated: 2020-01-31
Results Overview
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. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
COMPLETED
NA
185 participants
Pre-application to Post-application on Day 0
2020-01-31
Participant Flow
Intranasal and Extranasal data for this crossover study are combined because there is only access to combined arm data for this study. The study was acquired from another organization and limited results data are available.
Participant milestones
| Measure |
All Participants
Intranasal Tear Neurostimulator device, intranasal or extranasal (control) 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 controlled adverse environment (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. Randomization determined the order of intranasal or extranasal application.
|
|---|---|
|
Overall Study
STARTED
|
185
|
|
Overall Study
Safety Population: Entered CAE
|
171
|
|
Overall Study
COMPLETED
|
143
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
All Participants
Intranasal Tear Neurostimulator device, intranasal or extranasal (control) 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 controlled adverse environment (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. Randomization determined the order of intranasal or extranasal application.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Subject Choice
|
4
|
|
Overall Study
Received One Application
|
10
|
|
Overall Study
Received Neither Application
|
18
|
|
Overall Study
Enrollment cap
|
7
|
|
Overall Study
Investigator Discretion
|
1
|
Baseline Characteristics
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
Baseline characteristics by cohort
| Measure |
All Participants
n=185 Participants
Intranasal Tear Neurostimulator device, intranasal or extranasal (control) 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, 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. Randomization determined the order of intranasal or extranasal application.
|
|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-application to Post-application on Day 0Population: Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.
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. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Outcome measures
| Measure |
Intranasal Application
n=143 Participants
Intranasal Tear Neurostimulator applied intranasally device (active), 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 the CAE exposure.
|
Extranasal Application
n=143 Participants
Intranasal Tear Neurostimulator device applied extranasally (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 the CAE exposure.
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|---|---|---|
|
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
|
-16.48 score on a scale
Standard Error 1.692
|
-3.12 score on a scale
Standard Error 1.692
|
SECONDARY outcome
Timeframe: Pre-application to Post-application on Day 0Population: Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.
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 eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Outcome measures
| Measure |
Intranasal Application
n=143 Participants
Intranasal Tear Neurostimulator applied intranasally device (active), 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 the CAE exposure.
|
Extranasal Application
n=143 Participants
Intranasal Tear Neurostimulator device applied extranasally (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 the CAE exposure.
|
|---|---|---|
|
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
|
-0.93 score on a scale
Standard Error 0.080
|
-0.34 score on a scale
Standard Error 0.080
|
Adverse Events
All Participants
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