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Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
NCT06009458 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Study Locations (13)
California
- Advanced Optometry of Mission Viejo — Mission Viejo
- Elsa Pao, O.D. Optometrist — Oakland
- Pacific Rims Optometry — San Francisco
- Silicon Valley Eye Physicians — Sunnyvale
Other
- Innovative Eye Care — Adelaide
- Custom Eyecare Newcastle — Cooks Hill
- Eyeconic Optometry — Southport
- Rose Optometry — Hamilton
New York
- Center for Ophthalmic and Vision Research, LLC — New York
- Reed Eye Associates — Pittsford
Texas
- Bellaire Family Eye Care — Bellaire
- Queenston Eye Care — Houston
Florida
- Coan Eye Care — Ocoee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2025-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06009458
The ClinicalTrials.gov registry entry for NCT06009458 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 387 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acuity Polymers, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myopia appearing as the primary indexed condition, and to 1 intervention — of which Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06009458 reports 13 study locations spanning 5 distinct geographic areas — top geographies include California, Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06009458 about?
NCT06009458 is a clinical study titled "Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear". 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 ...
What is the current status of trial NCT06009458?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 387 participants. The study started on 2023-10-01. Estimated completion is 2025-09.
What conditions does trial NCT06009458 study?
This clinical trial studies the following conditions: Myopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06009458?
The interventions under investigation include: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06009458?
This trial is sponsored by Acuity Polymers, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06009458 being conducted?
This trial has 13 study locations across California, Florida, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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