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This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Attending Consultation for LASIK | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Treatment | Other | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients consulting with ophthalmologist for possible LASIK
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Attending Consultation for LASIK | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Attending Consultation for LASIK | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the 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 | Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale | The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress | All enrolled patients | Posted | Number | Percentage of Patients | Day 1 |
|
|
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Adverse events (AEs) and serious adverse events (SAEs) were not collected in this single day study, as no treatment was administered.
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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 | Patients Attending Consultation for LASIK | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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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: Female, Male | Count of Participants | Participants |
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| Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
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.