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This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects will be randomized into the Test/Control/Control sequence. |
|
| Control/Test/Test | Experimental | Eligible subjects will be randomized into the Control/Test/Test sequence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFUSE® One Day Multifocal | Device | Test Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at distance (4 meters) | Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at distance (4 meters) using ETDRS Charts. | 1-week follow-up |
| High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at intermediate (64 cm) | Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at intermediate (64 cm) using reduced Guillon-Poling charts. | 1-week follow-up |
| High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at near (40 cm) | Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at near (40 cm) using reduced Guillon-Poling charts. | 1-week follow-up |
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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 |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates, PA - City Square Blvd | Jacksonville | Florida | 32218 | United States | ||
| VRC |
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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| ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens |
| Device |
Control Lens |
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Pearson Research Center, PA | Longwood | Florida | 32779 | United States |
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Luxe Vision and Optical | Powell | Ohio | 43065 | United States |
| Dr. David W. Ferris & Associates | Warwick | Rhode Island | 02888 | United States |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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