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This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TrueTear | Experimental | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTear | Device | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eye Dryness Score | Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm. | Day 45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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Of the 57 enrolled subjects, 54 subjects completed the study. All 57 subjects enrolled in the study were included in FAS and safety populations
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| ID | Title | Description |
|---|---|---|
| FG000 | TrueTear | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TrueTear | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Eye Dryness Score | Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm. | Of the 57 subjects that initiated the study, 48 subjects achieved the threshold and performed an application in the CAE at Day 45. | Posted | Mean | Standard Error | Score on Scale | Day 45 |
|
Day 45
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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 | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan Sales LLC | 877-277-8566 | IR-CTRegistration@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 | Mar 10, 2017 | Jun 25, 2018 | 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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| Years |
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| Sex/Gender, Customized | Number | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
All data generated in this study is the property of Allergan. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Allergan