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TerminatedNCT03274999Updated Mar 8, 2021Results posted

Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

An interventional study of TrueTear™ Application in Dry Eye Syndromes, sponsored by Allergan. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by Allergan · Not applicable, Interventional, and Treatment

Why this study was terminated
Based on interim review and decision to re-design the study.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Dry Eye Syndromes

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
  • In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Exclusion criteria

Exclusion Criteria:

  • Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
  • History of nasal or sinus surgery
  • Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
  • Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit
  • Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    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.

    Device: TrueTear™ Application

  • Experimental
    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.

    Device: TrueTear™ Application

Interventions

  • DeviceTrueTear™ Application

    Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.

05

What researchers measure

Primary outcomes

  1. Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink

    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.

    Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

  2. Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink

    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 .

    Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

  3. Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)

    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.

    Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

  4. Change From Pre-application in Protective Index (PI)

    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.

    Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

  5. Change From Pre-application in Exposed Area (EA)

    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.

    Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

06

Results

Posted Mar 8, 2021

Participant flow

First Intervention (Day 0)
Participant flow — First Intervention (Day 0)
MilestoneTrueTear™ Intranasal Then Extranasal ApplicationTrueTear™ Extranasal Then Intranasal Application
Started55
Completed55
Not completed00
Second Intervention (Day 14)
Participant flow — Second Intervention (Day 14)
MilestoneTrueTear™ Intranasal Then Extranasal ApplicationTrueTear™ Extranasal Then Intranasal Application
Started55
Completed55
Not completed00

Outcome measures

PrimaryChange From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink

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.

Time frame:
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Reported as:
Mean · mm
Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
mmTrueTear™ Extranasal ApplicationTrueTear™ Intranasal Application
Eye-opening,Pre-application,Day 00.312 ± 0.1320.310 ± 0.143
Eye-opening,Change at T0 after application,Day 00.047 ± 0.2050.105 ± 0.177
Eye-opening,Change at T15 after application,Day 00.010 ± 0.1100.002 ± 0.096
Eye-opening,Change at T30 after application,Day 0-0.035 ± 0.118-0.003 ± 0.100
Eye-opening,Change at T60 after application,Day 0-0.018 ± 0.107-0.038 ± 0.092
Eye-opening,Change at T120 after application,Day 0-0.021 ± 0.138-0.039 ± 0.101
Eye-opening,Change at T180 after application,Day 0-0.049 ± 0.136-0.032 ± 0.103
Eye-opening,Change at T240 after application,Day 0-0.022 ± 0.125-0.033 ± 0.137
Eye-opening,Change at T300 after application,Day 0-0.055 ± 0.095-0.065 ± 0.110
Eye-opening,Change at T360 after application,Day 0-0.049 ± 0.111-0.060 ± 0.126
Pre-blink,Pre-application,Day 00.379 ± 0.1520.350 ± 0.143
Pre-blink,Change at T0 after application,Day 00.067 ± 0.2630.154 ± 0.231
Pre-blink,Change at T15 after application,Day 00.005 ± 0.1430.027 ± 0.097
Pre-blink,Change at T30 after application,Day 0-0.040 ± 0.1490.012 ± 0.105
Pre-blink,Change at T60 after application,Day 0-0.035 ± 0.159-0.008 ± 0.097
Pre-blink,Change at T120 after application,Day 0-0.050 ± 0.150-0.024 ± 0.097
Pre-blink,Change at T180 after application,Day 0-0.050 ± 0.153-0.039 ± 0.074
Pre-blink,Change at T240 after application,Day 0-0.018 ± 0.159-0.037 ± 0.132
Pre-blink,Change at T300 after application,Day 0-0.074 ± 0.133-0.070 ± 0.117
Pre-blink,Change at T360 after application,Day 0-0.054 ± 0.121-0.047 ± 0.129
Statistical analysis
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.156 (Eye-opening, T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.395 (Eye-opening, T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.114 (Eye-opening, T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.211 (Eye-opening, T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.332 (Eye-opening, T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.318 (Eye-opening, T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.375 (Eye-opening, T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.352 (Eye-opening, T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.312 (Eye-opening, T360: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.134 (Pre-blink, T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.315 (Pre-blink, T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.071 (Pre-blink, T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.260 (Pre-blink, T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.264 (Pre-blink, T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.381 (Pre-blink, T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.249 (Pre-blink, T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.451 (Pre-blink, T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.393 (Pre-blink, T360: P-value was calculated using 1-sided paired t-test.)
PrimaryChange From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink

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 .

Time frame:
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Reported as:
Mean · nm
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
nmTrueTear™ Extranasal ApplicationTrueTear™ Intranasal Application
Eye-opening,Pre-application,Day 041.090 ± 12.18533.541 ± 9.848
Eye-opening,Change at T0 after application,Day 00.325 ± 19.89025.255 ± 21.278
Eye-opening,Change at T15 after application,Day 0-2.527 ± 16.6806.154 ± 9.924
Eye-opening,Change at T30 after application,Day 0-6.820 ± 14.2926.944 ± 14.559
Eye-opening,Change at T60 after application,Day 0-2.542 ± 17.6656.174 ± 13.224
Eye-opening,Change at T120 after application,Day 0-6.385 ± 16.423-0.310 ± 11.519
Eye-opening,Change at T180 after application,Day 0-2.766 ± 12.6171.522 ± 9.387
Eye-opening,Change at T240 after application,Day 0-4.815 ± 16.9182.212 ± 9.965
Eye-opening,Change at T300 after application,Day 00.481 ± 16.7894.662 ± 12.366
Eye-opening,Change at T360 after application,Day 0-4.210 ± 14.3881.320 ± 9.393
Pre-blink,Pre-application,Day 046.498 ± 19.88045.330 ± 18.124
Pre-blink,Change at T0 after application,Day 03.907 ± 19.68923.203 ± 24.003
Pre-blink,Change at T15 after application,Day 0-1.145 ± 17.8244.018 ± 20.612
Pre-blink,Change at T30 after application,Day 0-3.662 ± 17.007-0.351 ± 19.049
Pre-blink,Change at T60 after application,Day 00.246 ± 20.5922.990 ± 19.916
Pre-blink,Change at T120 after application,Day 0-4.684 ± 17.573-3.939 ± 13.767
Pre-blink,Change at T180 after application,Day 0-3.373 ± 14.149-4.464 ± 10.932
Pre-blink,Change at T240 after application,Day 0-1.033 ± 17.147-4.381 ± 14.947
Pre-blink,Change at T300 after application,Day 01.700 ± 20.1571.725 ± 20.086
Pre-blink,Change at T360 after application,Day 0-3.730 ± 16.013-4.863 ± 13.992
Statistical analysis
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.006 (Eye-opening, T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.063 (Eye-opening, T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.005 (Eye-opening, T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.089 (Eye-opening, T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.112 (Eye-opening, T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.16 (Eye-opening, T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.077 (Eye-opening, T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.157 (Eye-opening, T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.111 (Eye-opening, T360: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.040 (Pre-blink, T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.241 (Pre-blink, T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.284 (Pre-blink, T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.313 (Pre-blink, T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.433 (Pre-blink, T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.406 (Pre-blink, T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.318 (Pre-blink, T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.499 (Pre-blink, T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.390 (Pre-blink, T360: P-value was calculated using 1-sided paired t-test.)
PrimaryChange From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)

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.

Time frame:
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Reported as:
Mean · seconds
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
secondsTrueTear™ Extranasal ApplicationTrueTear™ Intranasal Application
Pre-application, Day 018.211 ± 23.62610.536 ± 8.458
Change at T0 after application, Day 0-2.668 ± 16.8574.784 ± 13.738
Change at T15 after application, Day 0-2.489 ± 15.7880.835 ± 8.258
Change at T30 after application, Day 03.561 ± 19.045-0.639 ± 7.272
Change at T60 after application, Day 06.951 ± 27.848-0.954 ± 9.171
Change at T120 after application, Day 0-0.128 ± 14.1781.683 ± 7.172
Change at T180 after application, Day 04.911 ± 20.700-0.449 ± 6.029
Change at T240 after application, Day 01.525 ± 26.612-0.787 ± 9.026
Change at T300 after application, Day 0-0.387 ± 15.805-1.656 ± 5.560
Change at T360 after application, Day 0-1.509 ± 18.756-0.722 ± 8.369
Statistical analysis
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.053 (T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.206 (T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.221 (T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.126 (T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.124 (T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.167 (T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.377 (T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.397 (T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.441 (T360: P-value was calculated using 1-sided paired t-test.)
PrimaryChange From Pre-application in Protective Index (PI)

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.

Time frame:
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Reported as:
Mean · percentage of area covered by tear film
Change From Pre-application in Protective Index (PI)
percentage of area covered by tear filmTrueTear™ Extranasal ApplicationTrueTear™ Intranasal Application
Pre-application, Day 099.999 ± 0.00498.797 ± 5.351
Change at T0 after application, Day 0-0.003 ± 0.0151.200 ± 5.343
Change at T15 after application, Day 00.000 ± 0.0011.198 ± 5.352
Change at T30 after application, Day 0-0.009 ± 0.0361.196 ± 5.352
Change at T60 after application, Day 00.000 ± 0.0071.196 ± 5.352
Change at T120 after application, Day 00.000 ± 0.0021.179 ± 5.260
Change at T180 after application, Day 00.001 ± 0.0041.193 ± 5.353
Change at T240 after application, Day 0-0.005 ± 0.0201.196 ± 5.352
Change at T300 after application, Day 0-0.004 ± 0.0171.196 ± 5.352
Change at T360 after application, Day 00.000 ± 0.0031.198 ± 5.352
Statistical analysis
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.034 (T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.143 (T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.328 (T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.250 (T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.090 (T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.328 (T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.055 (T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.090 (T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.233 (T360: P-value was calculated using 1-sided paired t-test.)
PrimaryChange From Pre-application in Exposed Area (EA)

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.

Time frame:
Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Reported as:
Mean · percentage area not covered by tear film
Change From Pre-application in Exposed Area (EA)
percentage area not covered by tear filmTrueTear™ Extranasal ApplicationTrueTear™ Intranasal Application
Pre-application, Day 00.005 ± 0.0220.022 ± 0.057
Change at T0 after application, Day 00.014 ± 0.077-0.014 ± 0.035
Change at T15 after application, Day 0-0.002 ± 0.010-0.006 ± 0.046
Change at T30 after application, Day 00.033 ± 0.140-0.008 ± 0.051
Change at T60 after application, Day 0-0.001 ± 0.0290.001 ± 0.088
Change at T120 after application, Day 0-0.004 ± 0.0160.028 ± 0.145
Change at T180 after application, Day 0-0.005 ± 0.0220.011 ± 0.086
Change at T240 after application, Day 00.012 ± 0.040-0.008 ± 0.091
Change at T300 after application, Day 00.005 ± 0.022-0.002 ± 0.052
Change at T360 after application, Day 0-0.001 ± 0.018-0.006 ± 0.051
Statistical analysis
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.072 (T0: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.297 (T15: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.328 (T30: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.447 (T60: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.328 (T120: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.090 (T180: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.055 (T240: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.090 (T300: P-value was calculated using 1-sided paired t-test.)
  • TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application · t-test, 1 sided · p = 0.500 (T360: P-value was calculated using 1-sided paired t-test.)

Adverse events

Collected over Day 0 up to Day 14. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TrueTear™ Extranasal Application0/10 (0%)0/10 (0%)0/10 (0%)
TrueTear™ Intranasal Application0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

All participants who received TrueTear™ either intranasally or extranasally.

Age, Continuous
Age, Continuous(years)All Study Participants
Mean52.4 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female4
Male6
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All Study Participants
07

Study locations

1 site
  • Ocular Technology Group International
    London, SW1E 6AU, United Kingdom
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 9, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03274999
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Oct 18, 2017
Primary completion
Nov 9, 2017
Completion
Nov 9, 2017
Results posted
Mar 8, 2021
Last update
Mar 8, 2021

Study contacts

Clinical Director
study director · Allergan, plc

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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