Dry Eye Syndromes
Conditions
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).
Interventions
DEVICETrueTear™ Application
Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants randomized to receive TrueTear™ device either intranasally (test) or extranasally (control) on Days 0 and 14. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T180 after application, Day 0 | 4.911 seconds | Standard Deviation 20.7 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T30 after application, Day 0 | 3.561 seconds | Standard Deviation 19.045 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T60 after application, Day 0 | 6.951 seconds | Standard Deviation 27.848 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T240 after application, Day 0 | 1.525 seconds | Standard Deviation 26.612 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T300 after application, Day 0 | -0.387 seconds | Standard Deviation 15.805 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T360 after application, Day 0 | -1.509 seconds | Standard Deviation 18.756 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Pre-application, Day 0 | 18.211 seconds | Standard Deviation 23.626 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T0 after application, Day 0 | -2.668 seconds | Standard Deviation 16.857 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T120 after application, Day 0 | -0.128 seconds | Standard Deviation 14.178 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T15 after application, Day 0 | -2.489 seconds | Standard Deviation 15.788 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T0 after application, Day 0 | 4.784 seconds | Standard Deviation 13.738 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T15 after application, Day 0 | 0.835 seconds | Standard Deviation 8.258 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T360 after application, Day 0 | -0.722 seconds | Standard Deviation 8.369 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T30 after application, Day 0 | -0.639 seconds | Standard Deviation 7.272 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T60 after application, Day 0 | -0.954 seconds | Standard Deviation 9.171 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T180 after application, Day 0 | -0.449 seconds | Standard Deviation 6.029 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Pre-application, Day 0 | 10.536 seconds | Standard Deviation 8.458 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T240 after application, Day 0 | -0.787 seconds | Standard Deviation 9.026 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T120 after application, Day 0 | 1.683 seconds | Standard Deviation 7.172 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Change at T300 after application, Day 0 | -1.656 seconds | Standard Deviation 5.56 |
Comparison: 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.p-value: 0.053t-test, 1 sided
Comparison: 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.p-value: 0.206t-test, 1 sided
Comparison: 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.p-value: 0.221t-test, 1 sided
Comparison: 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.p-value: 0.126t-test, 1 sided
Comparison: 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.p-value: 0.124t-test, 1 sided
Comparison: 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.p-value: 0.167t-test, 1 sided
Comparison: 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.p-value: 0.377t-test, 1 sided
Comparison: 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.p-value: 0.397t-test, 1 sided
Comparison: 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.p-value: 0.441t-test, 1 sided
Primary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T30 after application,Day 0 | -6.820 nm | Standard Deviation 14.292 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T60 after application,Day 0 | 0.246 nm | Standard Deviation 20.592 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T180 after application,Day 0 | -2.766 nm | Standard Deviation 12.617 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T0 after application,Day 0 | 3.907 nm | Standard Deviation 19.689 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T15 after application,Day 0 | -1.145 nm | Standard Deviation 17.824 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T300 after application,Day 0 | 0.481 nm | Standard Deviation 16.789 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T0 after application,Day 0 | 0.325 nm | Standard Deviation 19.89 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T360 after application,Day 0 | -3.730 nm | Standard Deviation 16.013 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Pre-application,Day 0 | 41.090 nm | Standard Deviation 12.185 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T60 after application,Day 0 | -2.542 nm | Standard Deviation 17.665 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T15 after application,Day 0 | -2.527 nm | Standard Deviation 16.68 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T360 after application,Day 0 | -4.210 nm | Standard Deviation 14.388 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T120 after application,Day 0 | -4.684 nm | Standard Deviation 17.573 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T180 after application,Day 0 | -3.373 nm | Standard Deviation 14.149 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T30 after application,Day 0 | -3.662 nm | Standard Deviation 17.007 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T240 after application,Day 0 | -1.033 nm | Standard Deviation 17.147 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T240 after application,Day 0 | -4.815 nm | Standard Deviation 16.918 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T300 after application,Day 0 | 1.700 nm | Standard Deviation 20.157 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Pre-application,Day 0 | 46.498 nm | Standard Deviation 19.88 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T120 after application,Day 0 | -6.385 nm | Standard Deviation 16.423 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T360 after application,Day 0 | -4.863 nm | Standard Deviation 13.992 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T0 after application,Day 0 | 25.255 nm | Standard Deviation 21.278 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T240 after application,Day 0 | 2.212 nm | Standard Deviation 9.965 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T15 after application,Day 0 | 6.154 nm | Standard Deviation 9.924 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T30 after application,Day 0 | 6.944 nm | Standard Deviation 14.559 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T60 after application,Day 0 | 6.174 nm | Standard Deviation 13.224 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T120 after application,Day 0 | -0.310 nm | Standard Deviation 11.519 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T15 after application,Day 0 | 4.018 nm | Standard Deviation 20.612 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T300 after application,Day 0 | 4.662 nm | Standard Deviation 12.366 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T360 after application,Day 0 | 1.320 nm | Standard Deviation 9.393 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Pre-application,Day 0 | 45.330 nm | Standard Deviation 18.124 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T30 after application,Day 0 | -0.351 nm | Standard Deviation 19.049 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T60 after application,Day 0 | 2.990 nm | Standard Deviation 19.916 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T120 after application,Day 0 | -3.939 nm | Standard Deviation 13.767 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Pre-application,Day 0 | 33.541 nm | Standard Deviation 9.848 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T0 after application,Day 0 | 23.203 nm | Standard Deviation 24.003 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T180 after application,Day 0 | -4.464 nm | Standard Deviation 10.932 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T240 after application,Day 0 | -4.381 nm | Standard Deviation 14.947 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Pre-blink,Change at T300 after application,Day 0 | 1.725 nm | Standard Deviation 20.086 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Eye-opening,Change at T180 after application,Day 0 | 1.522 nm | Standard Deviation 9.387 |
Comparison: 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.p-value: 0.006t-test, 1 sided
Comparison: 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.p-value: 0.063t-test, 1 sided
Comparison: 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.p-value: 0.005t-test, 1 sided
Comparison: 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.p-value: 0.089t-test, 1 sided
Comparison: 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.p-value: 0.112t-test, 1 sided
Comparison: 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.p-value: 0.16t-test, 1 sided
Comparison: 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.p-value: 0.077t-test, 1 sided
Comparison: 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.p-value: 0.157t-test, 1 sided
Comparison: 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.p-value: 0.111t-test, 1 sided
Comparison: 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.p-value: 0.04t-test, 1 sided
Comparison: 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.p-value: 0.241t-test, 1 sided
Comparison: 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.p-value: 0.284t-test, 1 sided
Comparison: 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.p-value: 0.313t-test, 1 sided
Comparison: 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.p-value: 0.433t-test, 1 sided
Comparison: 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.p-value: 0.406t-test, 1 sided
Comparison: 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.p-value: 0.318t-test, 1 sided
Comparison: 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.p-value: 0.499t-test, 1 sided
Comparison: 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.p-value: 0.39t-test, 1 sided
Primary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T300 after application,Day 0 | -0.074 mm | Standard Deviation 0.133 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T0 after application,Day 0 | 0.047 mm | Standard Deviation 0.205 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T15 after application,Day 0 | 0.010 mm | Standard Deviation 0.11 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T30 after application,Day 0 | -0.035 mm | Standard Deviation 0.118 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T60 after application,Day 0 | -0.018 mm | Standard Deviation 0.107 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T120 after application,Day 0 | -0.021 mm | Standard Deviation 0.138 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T180 after application,Day 0 | -0.049 mm | Standard Deviation 0.136 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T240 after application,Day 0 | -0.022 mm | Standard Deviation 0.125 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T15 after application,Day 0 | 0.005 mm | Standard Deviation 0.143 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T30 after application,Day 0 | -0.040 mm | Standard Deviation 0.149 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T60 after application,Day 0 | -0.035 mm | Standard Deviation 0.159 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T120 after application,Day 0 | -0.050 mm | Standard Deviation 0.15 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T180 after application,Day 0 | -0.050 mm | Standard Deviation 0.153 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Pre-application,Day 0 | 0.312 mm | Standard Deviation 0.132 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T300 after application,Day 0 | -0.055 mm | Standard Deviation 0.095 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T360 after application,Day 0 | -0.049 mm | Standard Deviation 0.111 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Pre-application,Day 0 | 0.379 mm | Standard Deviation 0.152 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T0 after application,Day 0 | 0.067 mm | Standard Deviation 0.263 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T240 after application,Day 0 | -0.018 mm | Standard Deviation 0.159 |
| TrueTear™ Extranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T360 after application,Day 0 | -0.054 mm | Standard Deviation 0.121 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T300 after application,Day 0 | -0.065 mm | Standard Deviation 0.11 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Pre-application,Day 0 | 0.310 mm | Standard Deviation 0.143 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T30 after application,Day 0 | 0.012 mm | Standard Deviation 0.105 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T0 after application,Day 0 | 0.105 mm | Standard Deviation 0.177 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T360 after application,Day 0 | -0.047 mm | Standard Deviation 0.129 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T15 after application,Day 0 | 0.002 mm | Standard Deviation 0.096 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T60 after application,Day 0 | -0.008 mm | Standard Deviation 0.097 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T30 after application,Day 0 | -0.003 mm | Standard Deviation 0.1 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T360 after application,Day 0 | -0.060 mm | Standard Deviation 0.126 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T60 after application,Day 0 | -0.038 mm | Standard Deviation 0.092 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T120 after application,Day 0 | -0.024 mm | Standard Deviation 0.097 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T120 after application,Day 0 | -0.039 mm | Standard Deviation 0.101 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T240 after application,Day 0 | -0.037 mm | Standard Deviation 0.132 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T180 after application,Day 0 | -0.032 mm | Standard Deviation 0.103 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T300 after application,Day 0 | -0.070 mm | Standard Deviation 0.117 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Eye-opening,Change at T240 after application,Day 0 | -0.033 mm | Standard Deviation 0.137 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Pre-application,Day 0 | 0.350 mm | Standard Deviation 0.143 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T0 after application,Day 0 | 0.154 mm | Standard Deviation 0.231 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T180 after application,Day 0 | -0.039 mm | Standard Deviation 0.074 |
| TrueTear™ Intranasal Application | Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Pre-blink,Change at T15 after application,Day 0 | 0.027 mm | Standard Deviation 0.097 |
Comparison: 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.p-value: 0.395t-test, 1 sided
Comparison: 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.p-value: 0.156t-test, 1 sided
Comparison: 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.p-value: 0.114t-test, 1 sided
Comparison: 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.p-value: 0.211t-test, 1 sided
Comparison: 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.p-value: 0.332t-test, 1 sided
Comparison: 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.p-value: 0.318t-test, 1 sided
Comparison: 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.p-value: 0.375t-test, 1 sided
Comparison: 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.p-value: 0.352t-test, 1 sided
Comparison: 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.p-value: 0.312t-test, 1 sided
Comparison: 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.p-value: 0.134t-test, 1 sided
Comparison: 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.p-value: 0.315t-test, 1 sided
Comparison: 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.p-value: 0.071t-test, 1 sided
Comparison: 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.p-value: 0.26t-test, 1 sided
Comparison: 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.p-value: 0.264t-test, 1 sided
Comparison: 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.p-value: 0.381t-test, 1 sided
Comparison: 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.p-value: 0.249t-test, 1 sided
Comparison: 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.p-value: 0.451t-test, 1 sided
Comparison: 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.p-value: 0.393t-test, 1 sided
Primary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Pre-application, Day 0 | 0.005 percentage area not covered by tear film | Standard Deviation 0.022 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T0 after application, Day 0 | 0.014 percentage area not covered by tear film | Standard Deviation 0.077 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T15 after application, Day 0 | -0.002 percentage area not covered by tear film | Standard Deviation 0.01 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T30 after application, Day 0 | 0.033 percentage area not covered by tear film | Standard Deviation 0.14 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T60 after application, Day 0 | -0.001 percentage area not covered by tear film | Standard Deviation 0.029 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T120 after application, Day 0 | -0.004 percentage area not covered by tear film | Standard Deviation 0.016 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T180 after application, Day 0 | -0.005 percentage area not covered by tear film | Standard Deviation 0.022 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T240 after application, Day 0 | 0.012 percentage area not covered by tear film | Standard Deviation 0.04 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T300 after application, Day 0 | 0.005 percentage area not covered by tear film | Standard Deviation 0.022 |
| TrueTear™ Extranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T360 after application, Day 0 | -0.001 percentage area not covered by tear film | Standard Deviation 0.018 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T240 after application, Day 0 | -0.008 percentage area not covered by tear film | Standard Deviation 0.091 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Pre-application, Day 0 | 0.022 percentage area not covered by tear film | Standard Deviation 0.057 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T120 after application, Day 0 | 0.028 percentage area not covered by tear film | Standard Deviation 0.145 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T0 after application, Day 0 | -0.014 percentage area not covered by tear film | Standard Deviation 0.035 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T360 after application, Day 0 | -0.006 percentage area not covered by tear film | Standard Deviation 0.051 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T15 after application, Day 0 | -0.006 percentage area not covered by tear film | Standard Deviation 0.046 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T180 after application, Day 0 | 0.011 percentage area not covered by tear film | Standard Deviation 0.086 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T30 after application, Day 0 | -0.008 percentage area not covered by tear film | Standard Deviation 0.051 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T300 after application, Day 0 | -0.002 percentage area not covered by tear film | Standard Deviation 0.052 |
| TrueTear™ Intranasal Application | Change From Pre-application in Exposed Area (EA) | Change at T60 after application, Day 0 | 0.001 percentage area not covered by tear film | Standard Deviation 0.088 |
Comparison: 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.p-value: 0.072t-test, 1 sided
Comparison: 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.p-value: 0.297t-test, 1 sided
Comparison: 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.p-value: 0.328t-test, 1 sided
Comparison: 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.p-value: 0.447t-test, 1 sided
Comparison: 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.p-value: 0.328t-test, 1 sided
Comparison: 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.p-value: 0.09t-test, 1 sided
Comparison: 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.p-value: 0.055t-test, 1 sided
Comparison: 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.p-value: 0.09t-test, 1 sided
Comparison: 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.p-value: 0.5t-test, 1 sided
Primary
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Pre-application, Day 0 | 99.999 percentage of area covered by tear film | Standard Deviation 0.004 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T0 after application, Day 0 | -0.003 percentage of area covered by tear film | Standard Deviation 0.015 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T60 after application, Day 0 | 0.000 percentage of area covered by tear film | Standard Deviation 0.007 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T120 after application, Day 0 | 0.000 percentage of area covered by tear film | Standard Deviation 0.002 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T180 after application, Day 0 | 0.001 percentage of area covered by tear film | Standard Deviation 0.004 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T240 after application, Day 0 | -0.005 percentage of area covered by tear film | Standard Deviation 0.02 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T300 after application, Day 0 | -0.004 percentage of area covered by tear film | Standard Deviation 0.017 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T360 after application, Day 0 | 0.000 percentage of area covered by tear film | Standard Deviation 0.003 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T15 after application, Day 0 | 0.000 percentage of area covered by tear film | Standard Deviation 0.001 |
| TrueTear™ Extranasal Application | Change From Pre-application in Protective Index (PI) | Change at T30 after application, Day 0 | -0.009 percentage of area covered by tear film | Standard Deviation 0.036 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T360 after application, Day 0 | 1.198 percentage of area covered by tear film | Standard Deviation 5.352 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Pre-application, Day 0 | 98.797 percentage of area covered by tear film | Standard Deviation 5.351 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T240 after application, Day 0 | 1.196 percentage of area covered by tear film | Standard Deviation 5.352 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T0 after application, Day 0 | 1.200 percentage of area covered by tear film | Standard Deviation 5.343 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T30 after application, Day 0 | 1.196 percentage of area covered by tear film | Standard Deviation 5.352 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T180 after application, Day 0 | 1.193 percentage of area covered by tear film | Standard Deviation 5.353 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T60 after application, Day 0 | 1.196 percentage of area covered by tear film | Standard Deviation 5.352 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T300 after application, Day 0 | 1.196 percentage of area covered by tear film | Standard Deviation 5.352 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T120 after application, Day 0 | 1.179 percentage of area covered by tear film | Standard Deviation 5.26 |
| TrueTear™ Intranasal Application | Change From Pre-application in Protective Index (PI) | Change at T15 after application, Day 0 | 1.198 percentage of area covered by tear film | Standard Deviation 5.352 |
Comparison: 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.p-value: 0.034t-test, 1 sided
Comparison: 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.p-value: 0.143t-test, 1 sided
Comparison: 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.p-value: 0.328t-test, 1 sided
Comparison: 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.p-value: 0.25t-test, 1 sided
Comparison: 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.p-value: 0.09t-test, 1 sided
Comparison: 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.p-value: 0.328t-test, 1 sided
Comparison: 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.p-value: 0.055t-test, 1 sided
Comparison: 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.p-value: 0.09t-test, 1 sided
Comparison: 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.p-value: 0.233t-test, 1 sided