Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT03274999
Collaborator
(none)
10
1
2
22
13.8
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
Actual Study Start Date
:
Oct 18, 2017
Actual Primary Completion Date
:
Nov 9, 2017
Actual Study Completion Date
:
Nov 9, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.
|
| 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
Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink [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.
- Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink [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 .
- Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) [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.
- Change From Pre-application in Protective Index (PI) [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.
- Change From Pre-application in Exposed Area (EA) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ocular Technology Group International | London | United Kingdom | SW1E 6AU |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Clinical Director, Allergan, plc
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03274999
Other Study ID Numbers:
- OCUN-020
First Posted:
Sep 7, 2017
Last Update Posted:
Mar 8, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TrueTear™ Intranasal Then Extranasal Application | TrueTear™ Extranasal Then Intranasal Application |
|---|---|---|
| Arm/Group Description | 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™ 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. |
| Period Title: First Intervention (Day 0) | ||
| STARTED | 5 | 5 |
| COMPLETED | 5 | 5 |
| NOT COMPLETED | 0 | 0 |
| Period Title: First Intervention (Day 0) | ||
| STARTED | 5 | 5 |
| COMPLETED | 5 | 5 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | All participants randomized to receive TrueTear™ device either intranasally (test) or extranasally (control) on Days 0 and 14. |
| Overall Participants | 10 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.4
(10.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
40%
|
| Male |
6
60%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application |
|---|---|---|
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
| Measure Participants | 10 | 10 |
| Eye-opening,Pre-application,Day 0 |
0.312
(0.132)
|
0.310
(0.143)
|
| Eye-opening,Change at T0 after application,Day 0 |
0.047
(0.205)
|
0.105
(0.177)
|
| Eye-opening,Change at T15 after application,Day 0 |
0.010
(0.110)
|
0.002
(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 0 |
0.379
(0.152)
|
0.350
(0.143)
|
| Pre-blink,Change at T0 after application,Day 0 |
0.067
(0.263)
|
0.154
(0.231)
|
| Pre-blink,Change at T15 after application,Day 0 |
0.005
(0.143)
|
0.027
(0.097)
|
| Pre-blink,Change at T30 after application,Day 0 |
-0.040
(0.149)
|
0.012
(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 1
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.156 |
| Comments | Eye-opening, T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.395 |
| Comments | Eye-opening, T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.114 |
| Comments | Eye-opening, T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.211 |
| Comments | Eye-opening, T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.332 |
| Comments | Eye-opening, T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.318 |
| Comments | Eye-opening, T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.375 |
| Comments | Eye-opening, T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.352 |
| Comments | Eye-opening, T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.312 |
| Comments | Eye-opening, T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.134 |
| Comments | Pre-blink, T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.315 |
| Comments | Pre-blink, T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.071 |
| Comments | Pre-blink, T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.260 |
| Comments | Pre-blink, T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.264 |
| Comments | Pre-blink, T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.381 |
| Comments | Pre-blink, T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.249 |
| Comments | Pre-blink, T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.451 |
| Comments | Pre-blink, T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.393 |
| Comments | Pre-blink, T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application |
|---|---|---|
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
| Measure Participants | 10 | 10 |
| Eye-opening,Pre-application,Day 0 |
41.090
(12.185)
|
33.541
(9.848)
|
| Eye-opening,Change at T0 after application,Day 0 |
0.325
(19.890)
|
25.255
(21.278)
|
| Eye-opening,Change at T15 after application,Day 0 |
-2.527
(16.680)
|
6.154
(9.924)
|
| Eye-opening,Change at T30 after application,Day 0 |
-6.820
(14.292)
|
6.944
(14.559)
|
| Eye-opening,Change at T60 after application,Day 0 |
-2.542
(17.665)
|
6.174
(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
(12.617)
|
1.522
(9.387)
|
| Eye-opening,Change at T240 after application,Day 0 |
-4.815
(16.918)
|
2.212
(9.965)
|
| Eye-opening,Change at T300 after application,Day 0 |
0.481
(16.789)
|
4.662
(12.366)
|
| Eye-opening,Change at T360 after application,Day 0 |
-4.210
(14.388)
|
1.320
(9.393)
|
| Pre-blink,Pre-application,Day 0 |
46.498
(19.880)
|
45.330
(18.124)
|
| Pre-blink,Change at T0 after application,Day 0 |
3.907
(19.689)
|
23.203
(24.003)
|
| Pre-blink,Change at T15 after application,Day 0 |
-1.145
(17.824)
|
4.018
(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 0 |
0.246
(20.592)
|
2.990
(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 0 |
1.700
(20.157)
|
1.725
(20.086)
|
| Pre-blink,Change at T360 after application,Day 0 |
-3.730
(16.013)
|
-4.863
(13.992)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | Eye-opening, T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.063 |
| Comments | Eye-opening, T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | Eye-opening, T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.089 |
| Comments | Eye-opening, T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.112 |
| Comments | Eye-opening, T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | Eye-opening, T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.077 |
| Comments | Eye-opening, T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.157 |
| Comments | Eye-opening, T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.111 |
| Comments | Eye-opening, T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.040 |
| Comments | Pre-blink, T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.241 |
| Comments | Pre-blink, T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | Pre-blink, T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.313 |
| Comments | Pre-blink, T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.433 |
| Comments | Pre-blink, T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.406 |
| Comments | Pre-blink, T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.318 |
| Comments | Pre-blink, T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.499 |
| Comments | Pre-blink, T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.390 |
| Comments | Pre-blink, T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application |
|---|---|---|
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
| Measure Participants | 10 | 10 |
| Pre-application, Day 0 |
18.211
(23.626)
|
10.536
(8.458)
|
| Change at T0 after application, Day 0 |
-2.668
(16.857)
|
4.784
(13.738)
|
| Change at T15 after application, Day 0 |
-2.489
(15.788)
|
0.835
(8.258)
|
| Change at T30 after application, Day 0 |
3.561
(19.045)
|
-0.639
(7.272)
|
| Change at T60 after application, Day 0 |
6.951
(27.848)
|
-0.954
(9.171)
|
| Change at T120 after application, Day 0 |
-0.128
(14.178)
|
1.683
(7.172)
|
| Change at T180 after application, Day 0 |
4.911
(20.700)
|
-0.449
(6.029)
|
| Change at T240 after application, Day 0 |
1.525
(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 1
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.206 |
| Comments | T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.221 |
| Comments | T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.126 |
| Comments | T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.124 |
| Comments | T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.167 |
| Comments | T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.377 |
| Comments | T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.397 |
| Comments | T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.441 |
| Comments | T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change From Pre-application in Protective Index (PI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application |
|---|---|---|
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
| Measure Participants | 10 | 10 |
| Pre-application, Day 0 |
99.999
(0.004)
|
98.797
(5.351)
|
| Change at T0 after application, Day 0 |
-0.003
(0.015)
|
1.200
(5.343)
|
| Change at T15 after application, Day 0 |
0.000
(0.001)
|
1.198
(5.352)
|
| Change at T30 after application, Day 0 |
-0.009
(0.036)
|
1.196
(5.352)
|
| Change at T60 after application, Day 0 |
0.000
(0.007)
|
1.196
(5.352)
|
| Change at T120 after application, Day 0 |
0.000
(0.002)
|
1.179
(5.260)
|
| Change at T180 after application, Day 0 |
0.001
(0.004)
|
1.193
(5.353)
|
| Change at T240 after application, Day 0 |
-0.005
(0.020)
|
1.196
(5.352)
|
| Change at T300 after application, Day 0 |
-0.004
(0.017)
|
1.196
(5.352)
|
| Change at T360 after application, Day 0 |
0.000
(0.003)
|
1.198
(5.352)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.034 |
| Comments | T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.143 |
| Comments | T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.328 |
| Comments | T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.250 |
| Comments | T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.328 |
| Comments | T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.233 |
| Comments | T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change From Pre-application in Exposed Area (EA) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application |
|---|---|---|
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
| Measure Participants | 10 | 10 |
| Pre-application, Day 0 |
0.005
(0.022)
|
0.022
(0.057)
|
| Change at T0 after application, Day 0 |
0.014
(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 0 |
0.033
(0.140)
|
-0.008
(0.051)
|
| Change at T60 after application, Day 0 |
-0.001
(0.029)
|
0.001
(0.088)
|
| Change at T120 after application, Day 0 |
-0.004
(0.016)
|
0.028
(0.145)
|
| Change at T180 after application, Day 0 |
-0.005
(0.022)
|
0.011
(0.086)
|
| Change at T240 after application, Day 0 |
0.012
(0.040)
|
-0.008
(0.091)
|
| Change at T300 after application, Day 0 |
0.005
(0.022)
|
-0.002
(0.052)
|
| Change at T360 after application, Day 0 |
-0.001
(0.018)
|
-0.006
(0.051)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.072 |
| Comments | T0: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.297 |
| Comments | T15: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.328 |
| Comments | T30: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.447 |
| Comments | T60: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.328 |
| Comments | T120: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | T180: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | T240: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.090 |
| Comments | T300: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TrueTear™ Extranasal Application, TrueTear™ Intranasal Application |
|---|---|---|
| Comments | The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.500 |
| Comments | T360: P-value was calculated using 1-sided paired t-test. | |
| Method | t-test, 1 sided | |
| Comments | ||
Adverse Events
| Time Frame | Day 0 up to Day 14 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all participants that initiated at least one application. | |||
| Arm/Group Title | TrueTear™ Extranasal Application | TrueTear™ Intranasal Application | ||
| Arm/Group Description | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. | ||
All Cause Mortality |
||||
| TrueTear™ Extranasal Application | TrueTear™ Intranasal Application | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| TrueTear™ Extranasal Application | TrueTear™ Intranasal Application | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TrueTear™ Extranasal Application | TrueTear™ Intranasal Application | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area, Head |
|---|---|
| Organization | Allergan |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03274999
Other Study ID Numbers:
- OCUN-020
First Posted:
Sep 7, 2017
Last Update Posted:
Mar 8, 2021
Last Verified:
Mar 1, 2021