Trial Outcomes & Findings for Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use (NCT NCT03274999)
NCT ID: NCT03274999
Last Updated: 2021-03-08
Results Overview
Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Results posted on
2021-03-08
Participant Flow
Participant milestones
| Measure |
TrueTear™ Intranasal Then Extranasal Application
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.
|
TrueTear™ Extranasal Then Intranasal Application
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.
|
|---|---|---|
|
First Intervention (Day 0)
STARTED
|
5
|
5
|
|
First Intervention (Day 0)
COMPLETED
|
5
|
5
|
|
First Intervention (Day 0)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Day 14)
STARTED
|
5
|
5
|
|
Second Intervention (Day 14)
COMPLETED
|
5
|
5
|
|
Second Intervention (Day 14)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants randomized to receive TrueTear ™ device either intranasally or extranasally on Days 0 and 14.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
All participants randomized to receive TrueTear™ device either intranasally (test) or extranasally (control) on Days 0 and 14.
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.1 • n=10 Participants • All participants randomized to receive TrueTear ™ device either intranasally or extranasally on Days 0 and 14.
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after applicationPopulation: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.
Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Outcome measures
| Measure |
TrueTear™ Extranasal Application
n=10 Participants
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
|
TrueTear™ Intranasal Application
n=10 Participants
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
|
|---|---|---|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Pre-application,Day 0
|
0.312 mm
Standard Deviation 0.132
|
0.310 mm
Standard Deviation 0.143
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T0 after application,Day 0
|
0.047 mm
Standard Deviation 0.205
|
0.105 mm
Standard Deviation 0.177
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T15 after application,Day 0
|
0.010 mm
Standard Deviation 0.110
|
0.002 mm
Standard Deviation 0.096
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T30 after application,Day 0
|
-0.035 mm
Standard Deviation 0.118
|
-0.003 mm
Standard Deviation 0.100
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T60 after application,Day 0
|
-0.018 mm
Standard Deviation 0.107
|
-0.038 mm
Standard Deviation 0.092
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T120 after application,Day 0
|
-0.021 mm
Standard Deviation 0.138
|
-0.039 mm
Standard Deviation 0.101
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T180 after application,Day 0
|
-0.049 mm
Standard Deviation 0.136
|
-0.032 mm
Standard Deviation 0.103
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T240 after application,Day 0
|
-0.022 mm
Standard Deviation 0.125
|
-0.033 mm
Standard Deviation 0.137
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T300 after application,Day 0
|
-0.055 mm
Standard Deviation 0.095
|
-0.065 mm
Standard Deviation 0.110
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Eye-opening,Change at T360 after application,Day 0
|
-0.049 mm
Standard Deviation 0.111
|
-0.060 mm
Standard Deviation 0.126
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Pre-application,Day 0
|
0.379 mm
Standard Deviation 0.152
|
0.350 mm
Standard Deviation 0.143
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T0 after application,Day 0
|
0.067 mm
Standard Deviation 0.263
|
0.154 mm
Standard Deviation 0.231
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T15 after application,Day 0
|
0.005 mm
Standard Deviation 0.143
|
0.027 mm
Standard Deviation 0.097
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T30 after application,Day 0
|
-0.040 mm
Standard Deviation 0.149
|
0.012 mm
Standard Deviation 0.105
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T60 after application,Day 0
|
-0.035 mm
Standard Deviation 0.159
|
-0.008 mm
Standard Deviation 0.097
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T120 after application,Day 0
|
-0.050 mm
Standard Deviation 0.150
|
-0.024 mm
Standard Deviation 0.097
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T180 after application,Day 0
|
-0.050 mm
Standard Deviation 0.153
|
-0.039 mm
Standard Deviation 0.074
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T240 after application,Day 0
|
-0.018 mm
Standard Deviation 0.159
|
-0.037 mm
Standard Deviation 0.132
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T300 after application,Day 0
|
-0.074 mm
Standard Deviation 0.133
|
-0.070 mm
Standard Deviation 0.117
|
|
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Pre-blink,Change at T360 after application,Day 0
|
-0.054 mm
Standard Deviation 0.121
|
-0.047 mm
Standard Deviation 0.129
|
PRIMARY outcome
Timeframe: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after applicationPopulation: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.
Lipid layer thickness is defined as the average thickness of the lipid layer calculated from the thickness of the various pattern weighted by the relative coverage of each pattern measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement .
Outcome measures
| Measure |
TrueTear™ Extranasal Application
n=10 Participants
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
|
TrueTear™ Intranasal Application
n=10 Participants
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
|
|---|---|---|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Pre-application,Day 0
|
41.090 nm
Standard Deviation 12.185
|
33.541 nm
Standard Deviation 9.848
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T0 after application,Day 0
|
0.325 nm
Standard Deviation 19.890
|
25.255 nm
Standard Deviation 21.278
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T15 after application,Day 0
|
-2.527 nm
Standard Deviation 16.680
|
6.154 nm
Standard Deviation 9.924
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T30 after application,Day 0
|
-6.820 nm
Standard Deviation 14.292
|
6.944 nm
Standard Deviation 14.559
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T60 after application,Day 0
|
-2.542 nm
Standard Deviation 17.665
|
6.174 nm
Standard Deviation 13.224
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T120 after application,Day 0
|
-6.385 nm
Standard Deviation 16.423
|
-0.310 nm
Standard Deviation 11.519
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T180 after application,Day 0
|
-2.766 nm
Standard Deviation 12.617
|
1.522 nm
Standard Deviation 9.387
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T240 after application,Day 0
|
-4.815 nm
Standard Deviation 16.918
|
2.212 nm
Standard Deviation 9.965
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T300 after application,Day 0
|
0.481 nm
Standard Deviation 16.789
|
4.662 nm
Standard Deviation 12.366
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Eye-opening,Change at T360 after application,Day 0
|
-4.210 nm
Standard Deviation 14.388
|
1.320 nm
Standard Deviation 9.393
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Pre-application,Day 0
|
46.498 nm
Standard Deviation 19.880
|
45.330 nm
Standard Deviation 18.124
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T0 after application,Day 0
|
3.907 nm
Standard Deviation 19.689
|
23.203 nm
Standard Deviation 24.003
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T15 after application,Day 0
|
-1.145 nm
Standard Deviation 17.824
|
4.018 nm
Standard Deviation 20.612
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T30 after application,Day 0
|
-3.662 nm
Standard Deviation 17.007
|
-0.351 nm
Standard Deviation 19.049
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T60 after application,Day 0
|
0.246 nm
Standard Deviation 20.592
|
2.990 nm
Standard Deviation 19.916
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T120 after application,Day 0
|
-4.684 nm
Standard Deviation 17.573
|
-3.939 nm
Standard Deviation 13.767
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T180 after application,Day 0
|
-3.373 nm
Standard Deviation 14.149
|
-4.464 nm
Standard Deviation 10.932
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T240 after application,Day 0
|
-1.033 nm
Standard Deviation 17.147
|
-4.381 nm
Standard Deviation 14.947
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T300 after application,Day 0
|
1.700 nm
Standard Deviation 20.157
|
1.725 nm
Standard Deviation 20.086
|
|
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Pre-blink,Change at T360 after application,Day 0
|
-3.730 nm
Standard Deviation 16.013
|
-4.863 nm
Standard Deviation 13.992
|
PRIMARY outcome
Timeframe: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after applicationPopulation: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.
Non-invasive break-up time is the time in seconds between eye opening and the appearance of the first visible break in the lipid layer of the pre-corneal tear film measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Outcome measures
| Measure |
TrueTear™ Extranasal Application
n=10 Participants
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
|
TrueTear™ Intranasal Application
n=10 Participants
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
|
|---|---|---|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Pre-application, Day 0
|
18.211 seconds
Standard Deviation 23.626
|
10.536 seconds
Standard Deviation 8.458
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T0 after application, Day 0
|
-2.668 seconds
Standard Deviation 16.857
|
4.784 seconds
Standard Deviation 13.738
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T15 after application, Day 0
|
-2.489 seconds
Standard Deviation 15.788
|
0.835 seconds
Standard Deviation 8.258
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T30 after application, Day 0
|
3.561 seconds
Standard Deviation 19.045
|
-0.639 seconds
Standard Deviation 7.272
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T60 after application, Day 0
|
6.951 seconds
Standard Deviation 27.848
|
-0.954 seconds
Standard Deviation 9.171
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T120 after application, Day 0
|
-0.128 seconds
Standard Deviation 14.178
|
1.683 seconds
Standard Deviation 7.172
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T180 after application, Day 0
|
4.911 seconds
Standard Deviation 20.700
|
-0.449 seconds
Standard Deviation 6.029
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T240 after application, Day 0
|
1.525 seconds
Standard Deviation 26.612
|
-0.787 seconds
Standard Deviation 9.026
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T300 after application, Day 0
|
-0.387 seconds
Standard Deviation 15.805
|
-1.656 seconds
Standard Deviation 5.560
|
|
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Change at T360 after application, Day 0
|
-1.509 seconds
Standard Deviation 18.756
|
-0.722 seconds
Standard Deviation 8.369
|
PRIMARY outcome
Timeframe: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after applicationPopulation: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.
The Protected Index (PI) corresponds to the percentage of the corneal surface that is not exposed to the atmosphere (i.e. fully covered by the tear film) over the full interblink period measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.
Outcome measures
| Measure |
TrueTear™ Extranasal Application
n=10 Participants
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
|
TrueTear™ Intranasal Application
n=10 Participants
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
|
|---|---|---|
|
Change From Pre-application in Protective Index (PI)
Pre-application, Day 0
|
99.999 percentage of area covered by tear film
Standard Deviation 0.004
|
98.797 percentage of area covered by tear film
Standard Deviation 5.351
|
|
Change From Pre-application in Protective Index (PI)
Change at T0 after application, Day 0
|
-0.003 percentage of area covered by tear film
Standard Deviation 0.015
|
1.200 percentage of area covered by tear film
Standard Deviation 5.343
|
|
Change From Pre-application in Protective Index (PI)
Change at T15 after application, Day 0
|
0.000 percentage of area covered by tear film
Standard Deviation 0.001
|
1.198 percentage of area covered by tear film
Standard Deviation 5.352
|
|
Change From Pre-application in Protective Index (PI)
Change at T30 after application, Day 0
|
-0.009 percentage of area covered by tear film
Standard Deviation 0.036
|
1.196 percentage of area covered by tear film
Standard Deviation 5.352
|
|
Change From Pre-application in Protective Index (PI)
Change at T60 after application, Day 0
|
0.000 percentage of area covered by tear film
Standard Deviation 0.007
|
1.196 percentage of area covered by tear film
Standard Deviation 5.352
|
|
Change From Pre-application in Protective Index (PI)
Change at T120 after application, Day 0
|
0.000 percentage of area covered by tear film
Standard Deviation 0.002
|
1.179 percentage of area covered by tear film
Standard Deviation 5.260
|
|
Change From Pre-application in Protective Index (PI)
Change at T180 after application, Day 0
|
0.001 percentage of area covered by tear film
Standard Deviation 0.004
|
1.193 percentage of area covered by tear film
Standard Deviation 5.353
|
|
Change From Pre-application in Protective Index (PI)
Change at T240 after application, Day 0
|
-0.005 percentage of area covered by tear film
Standard Deviation 0.020
|
1.196 percentage of area covered by tear film
Standard Deviation 5.352
|
|
Change From Pre-application in Protective Index (PI)
Change at T300 after application, Day 0
|
-0.004 percentage of area covered by tear film
Standard Deviation 0.017
|
1.196 percentage of area covered by tear film
Standard Deviation 5.352
|
|
Change From Pre-application in Protective Index (PI)
Change at T360 after application, Day 0
|
0.000 percentage of area covered by tear film
Standard Deviation 0.003
|
1.198 percentage of area covered by tear film
Standard Deviation 5.352
|
PRIMARY outcome
Timeframe: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after applicationPopulation: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.
Exposed Area is defined as the percentage of the observed area not covered by the tear film at the time of the blink hence exposed to the atmosphere measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.
Outcome measures
| Measure |
TrueTear™ Extranasal Application
n=10 Participants
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14.
|
TrueTear™ Intranasal Application
n=10 Participants
TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14.
|
|---|---|---|
|
Change From Pre-application in Exposed Area (EA)
Pre-application, Day 0
|
0.005 percentage area not covered by tear film
Standard Deviation 0.022
|
0.022 percentage area not covered by tear film
Standard Deviation 0.057
|
|
Change From Pre-application in Exposed Area (EA)
Change at T0 after application, Day 0
|
0.014 percentage area not covered by tear film
Standard Deviation 0.077
|
-0.014 percentage area not covered by tear film
Standard Deviation 0.035
|
|
Change From Pre-application in Exposed Area (EA)
Change at T15 after application, Day 0
|
-0.002 percentage area not covered by tear film
Standard Deviation 0.010
|
-0.006 percentage area not covered by tear film
Standard Deviation 0.046
|
|
Change From Pre-application in Exposed Area (EA)
Change at T30 after application, Day 0
|
0.033 percentage area not covered by tear film
Standard Deviation 0.140
|
-0.008 percentage area not covered by tear film
Standard Deviation 0.051
|
|
Change From Pre-application in Exposed Area (EA)
Change at T60 after application, Day 0
|
-0.001 percentage area not covered by tear film
Standard Deviation 0.029
|
0.001 percentage area not covered by tear film
Standard Deviation 0.088
|
|
Change From Pre-application in Exposed Area (EA)
Change at T120 after application, Day 0
|
-0.004 percentage area not covered by tear film
Standard Deviation 0.016
|
0.028 percentage area not covered by tear film
Standard Deviation 0.145
|
|
Change From Pre-application in Exposed Area (EA)
Change at T180 after application, Day 0
|
-0.005 percentage area not covered by tear film
Standard Deviation 0.022
|
0.011 percentage area not covered by tear film
Standard Deviation 0.086
|
|
Change From Pre-application in Exposed Area (EA)
Change at T240 after application, Day 0
|
0.012 percentage area not covered by tear film
Standard Deviation 0.040
|
-0.008 percentage area not covered by tear film
Standard Deviation 0.091
|
|
Change From Pre-application in Exposed Area (EA)
Change at T300 after application, Day 0
|
0.005 percentage area not covered by tear film
Standard Deviation 0.022
|
-0.002 percentage area not covered by tear film
Standard Deviation 0.052
|
|
Change From Pre-application in Exposed Area (EA)
Change at T360 after application, Day 0
|
-0.001 percentage area not covered by tear film
Standard Deviation 0.018
|
-0.006 percentage area not covered by tear film
Standard Deviation 0.051
|
Adverse Events
TrueTear™ Extranasal Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TrueTear™ Intranasal 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 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