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This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter.
Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm | Experimental | Eligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence |
|
| Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter | Experimental | Eligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence |
|
| Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm | Experimental | Eligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence |
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| Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm | Experimental | Eligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence |
|
| Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE® OASYS 1-Day Sphere | Device | Lens for non-Presbyopes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) | Distance (4 meters) Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) without glare will be assessed after lens fitting. | Day 1 Post lens fitting |
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC | Jacksonville | Florida | 32256 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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Eligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence |
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| ACUVUE® OASYS Multifocal | Device | Lens for Prebyopes |
|