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ACTIVE NOT RECRUITING
NCT06009458
NA

Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

Sponsor: Acuity Polymers, Inc.

View on ClinicalTrials.gov

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

DEVICE

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