Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-04-06
Brief Title:
Acuity 200 Fluoroxyfocon A Orthokeratology Contact Lens for Overnight Wear
Sponsor:
Acuity Polymers Inc
Organization:
Acuity Polymers Inc
Study Overview
Official Title:
Clinical Evaluation of Safety and Effectiveness for Acuity 200 Fluoroxyfocon A Orthokeratology Contact Lens for Overnight Wear
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Acuity200OK
Brief 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 US 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 US 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
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 US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None