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Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Sponsor: Acuity Polymers, Inc.
Summary
The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).
Official title: Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Key Details
Gender
All
Age Range
7 Years - Any
Study Type
INTERVENTIONAL
Enrollment
387
Start Date
2023-10-01
Completion Date
2025-09
Last Updated
2025-01-14
Healthy Volunteers
No
Conditions
Interventions
Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Acuity 200™ Orthokeratology Contact Lenses are intended to be worn overnight with removal during following day. The lenses are designed to produce a temporary reduction of myopia by reversibly altering the curvature of the cornea. The lenses are manufactured from fluoroxyfocon A, which is a gas permeable contact lens material composed of a siloxanyl fluoromethacrylate copolymer. The material name fluoroxyfocon A is registered with United States Adopted Name (USAN).The Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens is available in spherical, asymmetrical, aspheric, and tangential lens designs to best fit the individual cornea, using corneal topography and/or diagnostic lenses.
Locations (13)
Advanced Optometry of Mission Viejo
Mission Viejo, California, United States
Elsa Pao, O.D. Optometrist
Oakland, California, United States
Pacific Rims Optometry
San Francisco, California, United States
Silicon Valley Eye Physicians
Sunnyvale, California, United States
Coan Eye Care
Ocoee, Florida, United States
Center for Ophthalmic and Vision Research, LLC
New York, New York, United States
Reed Eye Associates
Pittsford, New York, United States
Bellaire Family Eye Care
Bellaire, Texas, United States
Queenston Eye Care
Houston, Texas, United States
Innovative Eye Care
Adelaide, Australia
Custom Eyecare Newcastle
Cooks Hill, Australia
Eyeconic Optometry
Southport, Australia
Rose Optometry
Hamilton, New Zealand