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The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SofLens Daily Disposable | Experimental | SofLens Daily Disposable Lenses |
|
| Marketed 1 Day Contact Lens | Active Comparator | Marketed 1 Day Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SofLens Daily Disposable | Device | Lenses to be worn for 8-16 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance | Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness. | Insertion, 4 hours & End of Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Research Clinic | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SofLens Daily Disposable | SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours |
| FG001 | Marketed 1 Day Contact Lens | Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SofLens Daily Disposable | SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours |
| BG001 | Marketed 1 Day Contact Lens | Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Clinical Performance | Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness. | All eligible participants | Posted | Number | units on a scale | Insertion, 4 hours & End of Day |
|
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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 | SofLens Daily Disposable | SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | 585-338-6399 | Robert.Steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Marketed 1 Day Contact Lens |
| Device |
Lenses to be worn for 8-16 hours |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Marketed 1 Day Contact Lens | Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours | 0 | 28 | 0 | 28 |
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