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To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubricant Eye Drops FID 112903 | Experimental | Lubricant Eye Drops FID 112903 1 drop each eye one time |
|
| Optive Lubricant Eye Drops | Active Comparator | Optive Lubricant Eye Drops 1 drop each eye 1 time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubricant Eye Drops FID 112903 | Other | Lubricant Eye Drops FID 112903 1 drop each eye 1 time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drop Comfort Upon Instillation | Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable. | Three minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansfield | Mansfield | Texas | 76134 | United States |
Randomized, double-masked, crossover
20 Dry Eye Subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubricant Drops, Then Optive Drops | Patients received lubricant Drops first, then received Optive Drops |
| FG001 | Optive Drops, Then Lubricant Drops | Patients received Optive Drops first, then received Lubricant Drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second 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 Upon Instillation | Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable. | Posted | Mean | Standard Deviation | Units on a scale | Three minutes |
|
|
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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 | Lubricant Eye Drops FID 112903 | Lubricant Eye Drops FID 112903 |
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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 |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Lubricant Eye Drops | 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.