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First received: April 06, 2023

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

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Myopia

Study Type: INTERVENTIONAL


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

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 U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).

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