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To evaluate the safety and efficacy of two artificial tears in dry eye patients.
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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 | Other | SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-up Time | Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp. | Day 0, Day 7, Day 14, Day 28, and Day 42 |
| Conjunctival Staining | Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining. | Day 0, Day 7, Day 14, Day 28, Day 42 |
| Corneal Staining | Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining. | Day 0, Day 7, Day 14, Day 28, Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Call Center for Locations | Fort Worth | Texas | 76134 | United States |
Randomized, double-masked, parallel design
109 dry eye subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE Ultra | SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
| FG001 | OPTIVE Lubricant Eye Drops | OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE Ultra | SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
| BG001 | OPTIVE Lubricant Eye Drops | OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
| 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 | Tear Break-up Time | Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp. | Posted | Mean | Standard Deviation | seconds | Day 0, Day 7, Day 14, Day 28, and Day 42 |
|
From Day 0 to Day 42.
Adverse events were both volunteered and solicited.
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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 1 drop each eye 4 times daily for 42 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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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 | Other | Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Conjunctival Staining | Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Day 7, Day 14, Day 28, Day 42 |
|
|
|
| Primary | Corneal Staining | Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining. | Posted | Mean | Standard Deviation | Units on a scale | Day 0, Day 7, Day 14, Day 28, Day 42 |
|
|
|
| 0 |
| 53 |
| 3 |
| 53 |
| EG001 | OPTIVE Lubricant Eye Drops | OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days | 0 | 56 | 0 | 56 |
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.
| Day 14 |
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| Day 28 |
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| Day 42 |
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| Day 14 |
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| Day 28 |
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| Day 42 |
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