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To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Lubricant Eye Drops | Experimental | Systane Lubricant Eye Drops 1 drop in each eye one time |
|
| Optive Lubricant Eye Drops | Active Comparator | Optive Lubricant Eye Drops 1 drop each one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Lubricant Eye Drops | Other | Systane Lubricant Eye Drops 1 drop each eye once time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Blur | Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes. | 3 minutes post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Christensen | Alcon Research | Principal Investigator |
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24 hr. wash out between treatment periods
Medical Clinic Nov. 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Drops Then Optive Drops | Systane Drops then Optive Drops |
| FG001 | Optive Drops Then Systane Drops | Optive Drops then Systane Drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Drops Then Optive Drops | Systane Drops then Optive Drops |
| BG001 | Optive Drops Then Systane Drops | Optive Drops then Systane Drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Blur | Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes. | Posted | Mean | Full Range | Units on a scale | 3 minutes post dose |
|
|
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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 | Systane Lubricant Eye Drops | Systane lubricant eye drops |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Optive Lubricant Eye Drops | Other | Optive Lubricant Eye Drops 1 drop each eye one time |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Optive Lubricant Eye Drops | Optive Lubricant eye drops | 0 | 40 | 0 | 40 |
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