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Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Bausch & Lomb Contact Lens | Experimental | Novel Bausch & Lomb daily disposable contact lenses |
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| SofLens | Active Comparator | Bausch & Lomb SofLens daily disposable contact lenses |
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| Acuvue | Active Comparator | Johnson and Johnson 1-Day Acuvue Moist contact lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Bausch & Lomb daily disposable contact lenses | Device | Lenses to be worn and replaced daily for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater. | At dispensing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bev Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. James Ferrari | Rochester | New York | 14609 | United States |
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There were 567 participants enrolled (1134 eyes).
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Bausch & Lomb Contact Lens | Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks. |
| FG001 | SofLens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bausch & Lomb SofLens daily disposable contact lenses. | Device | Lenses to be worn and replaced daily for 2 weeks. |
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| Johnson and Johnson 1-Day Acuvue Moist contact lenses | Device | Lenses to be worn and replaced daily for 2 weeks. |
|
Bausch & Lomb SofLens daily disposable contact lenses
Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.
| FG002 | Acuvue | Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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There were 561 participants who were dispensed lenses (1122 eyes).
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Bausch & Lomb Contact Lens | Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks. |
| BG001 | SofLens | Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks. |
| BG002 | Acuvue | Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater. | Eyes that were dispensed contact lenses are included in the analysis population. | Posted | Count of Units | eyes | At dispensing | eyes | eyes |
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2 weeks
Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 378 eyes dispensed the test lens, 376 eyes dispensed the SofLens, and 378 eyes dispensed the Acuvue lens, assessed for adverse events.
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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 | Novel Bausch & Lomb Contact Lens | Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks. | 0 | 189 | 0 | 189 | ||
| EG001 | SofLens | Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks. | 0 | 188 | 0 | 188 | ||
| EG002 | Acuvue | Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks. | 0 | 189 | 0 | 189 |
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Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Comfort |
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| Vision |
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