18 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-BlinkPrimary· Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
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.
Eye-opening,Pre-application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.312
± 0.132
TrueTear™ Intranasal Application
0.310
± 0.143
Eye-opening,Change at T0 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.047
± 0.205
TrueTear™ Intranasal Application
0.105
± 0.177
Eye-opening,Change at T15 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.010
± 0.110
TrueTear™ Intranasal Application
0.002
± 0.096
Eye-opening,Change at T30 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.035
± 0.118
TrueTear™ Intranasal Application
-0.003
± 0.100
Eye-opening,Change at T60 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.018
± 0.107
TrueTear™ Intranasal Application
-0.038
± 0.092
Eye-opening,Change at T120 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.021
± 0.138
TrueTear™ Intranasal Application
-0.039
± 0.101
Eye-opening,Change at T180 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.049
± 0.136
TrueTear™ Intranasal Application
-0.032
± 0.103
Eye-opening,Change at T240 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.022
± 0.125
TrueTear™ Intranasal Application
-0.033
± 0.137
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-BlinkPrimary· Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
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 .
Eye-opening,Pre-application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
41.090
± 12.185
TrueTear™ Intranasal Application
33.541
± 9.848
Eye-opening,Change at T0 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.325
± 19.890
TrueTear™ Intranasal Application
25.255
± 21.278
Eye-opening,Change at T15 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-2.527
± 16.680
TrueTear™ Intranasal Application
6.154
± 9.924
Eye-opening,Change at T30 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-6.820
± 14.292
TrueTear™ Intranasal Application
6.944
± 14.559
Eye-opening,Change at T60 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-2.542
± 17.665
TrueTear™ Intranasal Application
6.174
± 13.224
Eye-opening,Change at T120 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-6.385
± 16.423
TrueTear™ Intranasal Application
-0.310
± 11.519
Eye-opening,Change at T180 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-2.766
± 12.617
TrueTear™ Intranasal Application
1.522
± 9.387
Eye-opening,Change at T240 after application,Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-4.815
± 16.918
TrueTear™ Intranasal Application
2.212
± 9.965
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)Primary· Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
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.
Pre-application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
18.211
± 23.626
TrueTear™ Intranasal Application
10.536
± 8.458
Change at T0 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-2.668
± 16.857
TrueTear™ Intranasal Application
4.784
± 13.738
Change at T15 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-2.489
± 15.788
TrueTear™ Intranasal Application
0.835
± 8.258
Change at T30 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
3.561
± 19.045
TrueTear™ Intranasal Application
-0.639
± 7.272
Change at T60 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
6.951
± 27.848
TrueTear™ Intranasal Application
-0.954
± 9.171
Change at T120 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.128
± 14.178
TrueTear™ Intranasal Application
1.683
± 7.172
Change at T180 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
4.911
± 20.700
TrueTear™ Intranasal Application
-0.449
± 6.029
Change at T240 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
1.525
± 26.612
TrueTear™ Intranasal Application
-0.787
± 9.026
Change From Pre-application in Protective Index (PI)Primary· Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
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.
Pre-application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
99.999
± 0.004
TrueTear™ Intranasal Application
98.797
± 5.351
Change at T0 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.003
± 0.015
TrueTear™ Intranasal Application
1.200
± 5.343
Change at T15 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.000
± 0.001
TrueTear™ Intranasal Application
1.198
± 5.352
Change at T30 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.009
± 0.036
TrueTear™ Intranasal Application
1.196
± 5.352
Change at T60 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.000
± 0.007
TrueTear™ Intranasal Application
1.196
± 5.352
Change at T120 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.000
± 0.002
TrueTear™ Intranasal Application
1.179
± 5.260
Change at T180 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.001
± 0.004
TrueTear™ Intranasal Application
1.193
± 5.353
Change at T240 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.005
± 0.020
TrueTear™ Intranasal Application
1.196
± 5.352
Change From Pre-application in Exposed Area (EA)Primary· Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
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.
Pre-application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.005
± 0.022
TrueTear™ Intranasal Application
0.022
± 0.057
Change at T0 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.014
± 0.077
TrueTear™ Intranasal Application
-0.014
± 0.035
Change at T15 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.002
± 0.010
TrueTear™ Intranasal Application
-0.006
± 0.046
Change at T30 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.033
± 0.140
TrueTear™ Intranasal Application
-0.008
± 0.051
Change at T60 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.001
± 0.029
TrueTear™ Intranasal Application
0.001
± 0.088
Change at T120 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.004
± 0.016
TrueTear™ Intranasal Application
0.028
± 0.145
Change at T180 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
-0.005
± 0.022
TrueTear™ Intranasal Application
0.011
± 0.086
Change at T240 after application, Day 0
Group
Value
95% CI
TrueTear™ Extranasal Application
0.012
± 0.040
TrueTear™ Intranasal Application
-0.008
± 0.091
Sponsor's own description
This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 8 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03274999.