NCT06009458

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

Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Acuity Polymers, Inc. · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Orthokeratology is an alternative method to correct refractive errors using individually designed gas permeable (rigid) lenses worn overnight to temporarily modify the curvature of cornea. Modern orthokeratology technology uses highly permeable rigid lens material and dynamic reverse geometry designs to allow faster and more effective corneal reshaping. Acuity 200™ (fluoroxyfocon A) is a stable material with relatively higher oxygen permeability compared to other marketed gas permeable materials. The clinical effects of wearing contact lenses that limit oxygen supply have been extensively reported with potential complications related to hypoxia including corneal swelling, epithelial microcysts, limbal hyperemia, corneal vascularization, refractive error changes and corneal distortion. Given the significantly higher oxygen permeability characteristics of Acuity 200™ (fluoroxyfocon A) relative to currently FDA approved orthokeratology materials, the material is well-suited for overnight wear applications-such as orthokeratology, when the eye is subject to hypoxic conditions during sleep. The objective of the clinical investigation (AVDR 2022-01) 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 the 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). The hypothesis is that the primary and secondary outcomes for safety and effectiveness are consistent with currently marketed devices approved by the FDA for overnight orthokeratology.

Conditions

• Myopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-08-24
• Last updated: 2025-01-14

Locations

13 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study