Myopia Clinical Trial - Acuity 200™ (Fluoroxyfocon A) Orthokeratology

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Myopia

Clinical Trial Details

NCT number	NCT06009458
Study type	Interventional
Source	Acuity Polymers, Inc.
Contact	James Bonafini
Phone	(585) 458-8409
Email	jim.bonafini@acuitypolymers.com
Status	Not yet recruiting
Phase	N/A
Start date	September 2023
Completion date	July 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear — Acuity200OK

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms