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

NCT06009458 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2025-01-14

No results posted yet for this study

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).

Conditions

  • Myopia

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.

Sponsors & Collaborators

  • Acuity Polymers, Inc.

    lead INDUSTRY

Principal Investigators

  • Mijeong Kwon Andre, MS · Andre Vision and Device Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06009458 on ClinicalTrials.gov