Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubricant Eye Drop FID 111421 | Experimental | Lubricant Eye Drop FID 111421 1 drop each eye one time |
|
| Optive Lubricant Eye Drop | Active Comparator | Optive Lubricant Eye Drop 1 drop each eye one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubricant Eye Drop FID 111421 | Other | Lubricant Eye Drop FID 111421 1 drop each eye one 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. | upon instillation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-masked, crossover
20 Dry Eye Subjects
Not provided
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | upon instillation |
|
|
Not provided
Not provided
Not provided
| 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 Drop FID 111421 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Optive Lubricant Eye Drop | Other | Optive Lubricant Eye Drop 1 drop each eye one time |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Optive Lubricant Eye Drop | 0 | 20 | 0 | 20 |
The PI should hold confidential, and not disclose directly or indirectly to any third party onther than Contractors, the data arising out of the study.