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This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tear Sample Collection | Procedure | Tear sample collection as per protocol. No investigational drug is administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Lipid Composition Profile | Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole). | Day 1 |
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Inclusion Criteria:
-Adult volunteers without ocular disease.
Exclusion Criteria:
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Adult volunteers without ocular disease.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Randwick | New South Wales | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. |
| 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 | Tear Lipid Composition Profile | Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole). | A subset of enrolled participants who had non-stimulated (basal) tear samples. | Posted | Mean | Standard Deviation | pmole | Day 1 |
|
|
Adverse Events were collected from Screening to Day 1.
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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 | All Participants | Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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Tears
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
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 no more than 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.