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To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Ultra Lubricant Eye Drops | Experimental | Systane Ultra Lubricant Eye Drops 1 drop each one time |
|
| Optive Lubricant Eye Drops | Active Comparator | Optive Lubricant Eye Drops 1 drop each eye one time |
|
| Blink Tears | Active Comparator | Blink Tears 1 drop each eye one time |
|
| GenTeal Moderate Lubricant Eye Drops | Active Comparator | GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra Lubricant Eye Drops | Other | Systane Ultra Lubricant Eye Drops one drop each eye one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drop Comfort | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable. | once upon instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
randomized, double-masked, cross-over design
20 dry eye subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate | Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last. |
| FG001 | Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane | Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane |
| FG002 | Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive | Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last |
| FG003 | GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears | Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Third Intervention |
| |||||||||||||
| Fourth Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 | Drop Comfort | Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable. | Posted | Mean | Standard Deviation | units on a scale | once upon instillation |
|
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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 Lubricant Eye Drops | 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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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Optive Lubricant Eye Drops | Other | Optive Lubricant Eye Drops one drop each eye one time |
|
| Blink Tears | Other | Blink Tears one drop each eye one time |
|
| GenTeal Moderate Lubricant Eye Drops | Other | GenTeal Moderate Lubricant Eye Drops one drop each eye one time |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | GenTeal Moderate Lubricant Eye Drops | GenTeal Moderate Lubricant Eye Drops |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Optive Lubricant Eye Drops | Optive Lubricant Eye Drops | 0 | 20 | 0 | 20 |
| EG002 | Blink Tears | Blink Tears | 0 | 20 | 0 | 20 |
| EG003 | GenTeal Moderate Lubricant Eye Drops | GenTeal Moderate Lubricant Eye Drops | 0 | 20 | 0 | 20 |
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.
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |