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Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kalifilcon A Daily Disposable Multifocal | Experimental | kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA) |
|
| samfilcon A for Presbyopia | Active Comparator | B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kalifilcon A Daily Disposable Multifocal | Device | kalifilcon A Daily Disposable Multifocal low add and high |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Mean Binocular logMAR Visual Acuity at Distance (6m) | One week |
| Near Visual Acuity | Mean Binocular logMAR Visual Acuity at Near (40cm) | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch site 1 | Rochester | New York | 14609 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2022 | Dec 20, 2022 | 1 | ||
| Apr 26, 2024 |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| samfilcon A for Presbyopia | Device | Ultra for Presbyopia Low and High Add Contact Lenses |
|
| May 23, 2024 |
| 2 |
| Oct 1, 2024 | Oct 23, 2024 | 3 |
| Jun 6, 2025 | Jun 23, 2025 | 4 |