North American Comfilcon A Clinical Study
Part of paid clinical trials in Berkeley, California.
- Sponsor
- CooperVision International Limited (CVIL)
- Study ID
- NCT06902584
- Status
- Recruiting
Conditions
- Ametropia
- Astigmatism
- Presbyopia
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- comfilcon A Sphere lens — DEVICE2 hours of wear
- comfilcon A Toric lens — DEVICE2 hours of wear
- comfilcon A Multifocal lens — DEVICE2 hours of wear
- comfilcon A Multifocal Toric lens — DEVICE2 hours of wear
- comfilcon A Energys lens — DEVICE2 hours of wear
Study Details
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.
Key Dates
- Start date
- Feb 5, 2025
- Status verified
- Aug 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 182 participants (estimated)
Arms
- Arm: comfilcon A Sphere Lens WearersHabitual comfilcon A Sphere Lens Wearers
- Arm: comfilcon A Toric Lens WearersHabitual comfilcon A Toric Lens Wearers
- Arm: comfilcon A Multifocal Lens WearersHabitual comfilcon A Multifocal Lens Wearers
- Arm: comfilcon A Multifocal Toric Lens WearersHabitual comfilcon A Multifocal Toric Lens Wearers
- Arm: comfilcon A Energys Lens WearersHabitual comfilcon A Energys Lens Wearers
Primary Outcome Measure
Visual Performance (Visual Acuity) [ Time Frame: At the end of 2 hours of wear ]
Central Contacts
- Jose A Vega, OD,MSc,PhD9256402964
- Jill Woods, MSc,MCOptom
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Berkeley | Berkeley | California | 94720 | Meng C Lin, OD,PhD |
| ProCare Vision Center | Granville | Ohio | 43023 | Katherine Bickle, Dr. |
| Nittany Eye Associates | College | Pennsylvania | 16801 | Abigail G Harsch, Dr. |
| Drs. McIntyre, Garza, Avila and Jurica, Optometrists | Corpus Christi | Texas | 78411 | David Browning, Dr. |
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