Trial Outcomes & Findings for Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease (NCT NCT03827564)
NCT ID: NCT03827564
Last Updated: 2021-08-16
Results Overview
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Screening (Day -60 to Day -30) to Application Visit (Day 0)
Results posted on
2021-08-16
Participant Flow
Participant milestones
| Measure |
ITN [TrueTear®] - Intranasal Application
Intranasal application of the ITN. Single application at application visit.
|
ITN [TrueTear®] - Extranasal Application
Extranasal application of the ITN. Single application at application visit.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ITN [TrueTear®] - Intranasal Application
Intranasal application of the ITN. Single application at application visit.
|
ITN [TrueTear®] - Extranasal Application
Extranasal application of the ITN. Single application at application visit.
|
|---|---|---|
|
Overall Study
Discontinued due to Study Termination
|
1
|
0
|
Baseline Characteristics
Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease
Baseline characteristics by cohort
| Measure |
ITN [TrueTear®] - Intranasal Application
n=9 Participants
Intranasal application of the ITN. Single application at application visit.
|
ITN [TrueTear®] - Extranasal Application
n=5 Participants
Extranasal application of the ITN. Single application at application visit.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 15.4 • n=99 Participants
|
46.8 Years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
52.2 Years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Screening (Day -60 to Day -30) to Application Visit (Day 0)Population: Of the 14 Randomized participants, 13 received a single application of the Intranasal Tear Neurostimulator (ITN)
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Outcome measures
| Measure |
ITN [TrueTear®] - Intranasal Application
n=6 Participants
Intranasal application of the ITN. Single application at application visit.
|
ITN [TrueTear®] - Extranasal Application
n=5 Participants
Extranasal application of the ITN. Single application at application visit.
|
|---|---|---|
|
Difference in Ratio of Degranulated Goblet Cells.
|
0.007 Ratio
Standard Deviation 0.171
|
0.124 Ratio
Standard Deviation 0.069
|
Adverse Events
ITN [TrueTear®] - Intranasal Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ITN [TrueTear®] - Extranasal Application
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 Allergan as the sponsor has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between investigators and Allergan personnel. Authorship will be established prior to the writing of the manuscript. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER