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To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Ultra | Experimental | Systane Ultra Lubricant Eye Drops |
|
| Optive | Active Comparator | Optive Lubricant Eye Drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra Lubricant Eye Drops | Other | Systane Ultra Lubricant Eye Drops 1 drop each eye one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time at Best Corrected Visual Acuity | Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can. | 15 minutes, 45 minutes, and 90 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Blink Rate Time (Time Between Blinks) | Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance. | 15 minutes, 45 minutes, and 90 minutes post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Andover | North Andover | Massachusetts | 01845 | United States |
Randomized, double-masked, crossover
48 Dry Eye Subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Ultra, Then Optive | Systane Ultra Lubricant Eye Drops first, then cross-over to Optive. |
| FG001 | Optive, Then Systane Ultra | Optive Lubricant Eye Drops first, then cross-over to Systane Ultra. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Overall Study |
| 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 | Time at Best Corrected Visual Acuity | Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can. | Posted | Median | Standard Error | seconds | 15 minutes, 45 minutes, and 90 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 Ultra | Systane Ultra Lubricant Eye Drops. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| 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 |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Functional Blink Rate Time (Time Between Blinks) | Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance. | Posted | Mean | Standard Deviation | seconds | 15 minutes, 45 minutes, and 90 minutes post-dose |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Optive | Optive Lubricant Eye Drops | 0 | 48 | 0 | 48 |
The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| 90 minutes post-dose |
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