Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06009458 · ClinicalTrials.gov registry record · NA
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
A NA study of Myopia, sponsored by Acuity Polymers.
- Active
- Registry status
- NA
- Development phase
- 387
- Enrollment target
- 13
- Study locations
NCT06009458: Active NA study of Myopia, sponsored by Acuity Polymers.
NCT06009458 is a NA study of Myopia that is active but no longer recruiting, run by Acuity Polymers. The registered enrollment target is 387 participants, above the 264-participant average among 90 other Myopia trials with a reported enrollment target (47% higher). The trial reports 13 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06009458, a NA study of Myopia, is active but no longer recruiting, sponsored by Acuity Polymers.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 387 participants
- Enrollment target
- 13
- Study locations
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).
Primary Outcome
The number of lines of change in acuity (for an eye) is defined as the difference in the logMAR acuities, scored to the letter, multiplied by 10. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value. The primary effectiveness endpoints described above will also be stratified by subjects' baseline age (including 7 to 11 years (children), 12 to 21 years (adolescents), and 22 years and older (adults) .
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 |
What the registry record for NCT06009458 still lists
NCT06009458 is an interventional study that assigns participants to a tested intervention. The registered 387 participants enrollment target is mid-sized for trials with a published cap, above the 264-participant average among 90 other Myopia trials with a reported enrollment target (47% higher).
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.
NCT06009458 lists 13 locations in 5 states (California, Other, New York).
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.
What interventions are being tested in trial NCT06009458?
The interventions under investigation include: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear (DEVICE).
Who is sponsoring clinical trial NCT06009458?
This trial is sponsored by Acuity Polymers, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Myopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06009458's enrollment target sits among peer trials
387 11th of 90 higher than 80 of 90 other Myopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy of Repeated Low-level Red-light Therapy in Myopia Control
RECRUITING · NA
-
Comprehensive Assessment of Multiple Products (CAMP)
RECRUITING · NA
-
Children's Viewing Behavior
RECRUITING · NA
-
Violet Light for the Suppression of Myopia
RECRUITING · NA
-
Measuring Outcomes of LASIK and EVO-ICL in Matched Populations
RECRUITING · NA
-
Wavelength Intervention for Nearsighted Kids
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03761108 · 387 participants · Phase 1
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
- NCT05572632 · 387 participants · NA
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
- NCT06917079 · 387 participants · Phase 1
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
- NCT04092010 · 388 participants · NA
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI