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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A Sphere Lens Wearers | Habitual comfilcon A Sphere Lens Wearers |
| |
| comfilcon A Toric Lens Wearers | Habitual comfilcon A Toric Lens Wearers |
| |
| comfilcon A Multifocal Lens Wearers | Habitual comfilcon A Multifocal Lens Wearers |
| |
| comfilcon A Multifocal Toric Lens Wearers | Habitual comfilcon A Multifocal Toric Lens Wearers |
| |
| comfilcon A Energys Lens Wearers | Habitual comfilcon A Energys Lens Wearers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A Sphere lens | Device | 2 hours of wear |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Performance (Visual Acuity) | Visual Performance will be measured using logMAR
| At the end of 2 hours of wear |
| Incidence of contact lens-related adverse events | Incidence of contact lens-related adverse events will be recorded from subjects | At the end of 2 hours of wear |
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Inclusion Criteria:
Exclusion Criteria:
1. Current participation in a contact lens or contact lens care product clinical trial.
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Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose A Vega, OD,MSc,PhD | Contact | 9256402964 | jvega2@coopervision.com | |
| Jill Woods, MSc,MCOptom | Contact | jwoods@uwaterloo.ca |
| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, OD, PhD | University of Berkeley | Principal Investigator |
| Katherine Bickle, Dr. | ProCare Vision Center | Principal Investigator |
| Abigail G Harsch, Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Berkeley | Recruiting | Berkeley | California | 94720 | United States |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| comfilcon A Toric lens |
| Device |
2 hours of wear |
|
| comfilcon A Multifocal lens | Device | 2 hours of wear |
|
| comfilcon A Multifocal Toric lens | Device | 2 hours of wear |
|
| comfilcon A Energys lens | Device | 2 hours of wear |
|
| Nittany Eye Associates |
| Principal Investigator |
| David Browning, Dr. | Drs. McIntyre, Garza, Avila and Jurica, Optometrists | Principal Investigator |
| ProCare Vision Center | Recruiting | Granville | Ohio | 43023 | United States |
|
| Nittany Eye Associates | Recruiting | College | Pennsylvania | 16801 | United States |
|
| Drs. McIntyre, Garza, Avila and Jurica, Optometrists | Recruiting | Corpus Christi | Texas | 78411 | United States |
|