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Based on interim review and decision to re-design the study.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TrueTear™ Intranasal then Extranasal Application | Experimental | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14. |
|
| TrueTear™ Extranasal then Intranasal Application | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTear™ Application | Device | Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
| 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 . | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
| 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. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Director | Allergan, plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Technology Group International | London | SW1E 6AU | United Kingdom |
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| Label | URL |
|---|---|
| For information to locate a study location near you, please visit AllerganClinicalTrials.com | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Day 0) |
| |||||||||||||
| Second Intervention (Day 14) |
|
All participants who received TrueTear™ either intranasally or extranasally.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants randomized to receive TrueTear™ device either intranasally (test) or extranasally (control) on Days 0 and 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All participants randomized to receive TrueTear ™ device either intranasally or extranasally on Days 0 and 14. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mm | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
|
Day 0 up to Day 14
Safety population included all participants that initiated at least one application.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TrueTear™ Extranasal Application | TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2017 | Nov 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
| 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. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
| NOT COMPLETED |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 or Day 14. |
| OG001 | TrueTear™ Intranasal Application | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. |
|
|
|
| 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 . | 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. | Posted | Mean | Standard Deviation | nm | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of area covered by tear film | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage area not covered by tear film | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | TrueTear™ Intranasal Application | TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 or Day 14. | 0 | 10 | 0 | 10 | 0 | 10 |
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.
| Eye-opening,Change at T15 after application,Day 0 |
|
| Eye-opening,Change at T30 after application,Day 0 |
|
| Eye-opening,Change at T60 after application,Day 0 |
|
| Eye-opening,Change at T120 after application,Day 0 |
|
| Eye-opening,Change at T180 after application,Day 0 |
|
| Eye-opening,Change at T240 after application,Day 0 |
|
| Eye-opening,Change at T300 after application,Day 0 |
|
| Eye-opening,Change at T360 after application,Day 0 |
|
| Pre-blink,Pre-application,Day 0 |
|
| Pre-blink,Change at T0 after application,Day 0 |
|
| Pre-blink,Change at T15 after application,Day 0 |
|
| Pre-blink,Change at T30 after application,Day 0 |
|
| Pre-blink,Change at T60 after application,Day 0 |
|
| Pre-blink,Change at T120 after application,Day 0 |
|
| Pre-blink,Change at T180 after application,Day 0 |
|
| Pre-blink,Change at T240 after application,Day 0 |
|
| Pre-blink,Change at T300 after application,Day 0 |
|
| Pre-blink,Change at T360 after application,Day 0 |
|
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. |
| t-test, 1 sided |
| 0.063 |
Eye-opening, T15: P-value was calculated using 1-sided paired t-test. |
| Superiority |
| 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. | t-test, 1 sided | 0.005 | Eye-opening, T30: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.089 | Eye-opening, T60: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.112 | Eye-opening, T120: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.16 | Eye-opening, T180: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.077 | Eye-opening, T240: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.157 | Eye-opening, T300: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.111 | Eye-opening, T360: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.040 | Pre-blink, T0: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.241 | Pre-blink, T15: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.284 | Pre-blink, T30: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.313 | Pre-blink, T60: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.433 | Pre-blink, T120: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.406 | Pre-blink, T180: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.318 | Pre-blink, T240: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.499 | Pre-blink, T300: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.390 | Pre-blink, T360: P-value was calculated using 1-sided paired t-test. | Superiority |
| Change at T15 after application, Day 0 |
|
| Change at T30 after application, Day 0 |
|
| Change at T60 after application, Day 0 |
|
| Change at T120 after application, Day 0 |
|
| Change at T180 after application, Day 0 |
|
| Change at T240 after application, Day 0 |
|
| Change at T300 after application, Day 0 |
|
| Change at T360 after application, Day 0 |
|
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. |
| t-test, 1 sided |
| 0.206 |
T15: P-value was calculated using 1-sided paired t-test. |
| Superiority |
| 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. | t-test, 1 sided | 0.221 | T30: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.126 | T60: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.124 | T120: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.167 | T180: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.377 | T240: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.397 | T300: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.441 | T360: P-value was calculated using 1-sided paired t-test. | Superiority |
| Change at T15 after application, Day 0 |
|
| Change at T30 after application, Day 0 |
|
| Change at T60 after application, Day 0 |
|
| Change at T120 after application, Day 0 |
|
| Change at T180 after application, Day 0 |
|
| Change at T240 after application, Day 0 |
|
| Change at T300 after application, Day 0 |
|
| Change at T360 after application, Day 0 |
|
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. |
| t-test, 1 sided |
| 0.143 |
T15: P-value was calculated using 1-sided paired t-test. |
| Superiority |
| 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. | t-test, 1 sided | 0.328 | T30: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.250 | T60: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.090 | T120: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.328 | T180: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.055 | T240: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.090 | T300: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.233 | T360: P-value was calculated using 1-sided paired t-test. | Superiority |
| Change at T15 after application, Day 0 |
|
| Change at T30 after application, Day 0 |
|
| Change at T60 after application, Day 0 |
|
| Change at T120 after application, Day 0 |
|
| Change at T180 after application, Day 0 |
|
| Change at T240 after application, Day 0 |
|
| Change at T300 after application, Day 0 |
|
| Change at T360 after application, Day 0 |
|
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. |
| t-test, 1 sided |
| 0.297 |
T15: P-value was calculated using 1-sided paired t-test. |
| Superiority |
| 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. | t-test, 1 sided | 0.328 | T30: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.447 | T60: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.328 | T120: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.090 | T180: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.055 | T240: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.090 | T300: P-value was calculated using 1-sided paired t-test. | Superiority |
| 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. | t-test, 1 sided | 0.500 | T360: P-value was calculated using 1-sided paired t-test. | Superiority |