Overnight Orthokeratology Lenses for Near-Sightedness
(Acuity200OK Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Acuity Polymers, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for individuals aged 7 or older with mild to moderate near-sightedness (-0.75 to -6.00 diopters) and astigmatism up to 1.75 DC, who have healthy eyes and can follow instructions for overnight contact lens wear. It's not suitable for pregnant women, those lacking psychological maturity, people with certain eye surgeries or diseases, abnormal corneal shapes, large pupils in light conditions, extreme keratometry values, or systemic diseases like diabetes.

Inclusion Criteria

Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits

I am 7 or older and can legally consent or have permission from a guardian.

Has naturally occurring refractive myopia from -0.75 to -6.00 diopters sphere (spectacle plane), with refractive astigmatism (spectacle plane) up to 1.75 DC-as determined by adjusted manifest refraction (phoropter or trial frame) with a 12.5 mm vertex distance

+2 more

Exclusion Criteria

Is pregnant, breast-feeding or intends to become pregnant over the course of the study

I am a child not mature enough to safely follow the required procedures.

Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity

+12 more

Participant Groups

The Acuity 200™ Orthokeratology Contact Lens is being tested for safety and effectiveness in correcting near-sightedness during overnight wear. The data collected will support a new application to the FDA. Participants must use the lenses as instructed and attend all follow-up visits.

1Treatment groups

Experimental Treatment

Group I: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearExperimental Treatment1 Intervention

For the orthokeratology treatment the subjects will be instructed to wear the study lenses each night during the hours of sleep (for a minimum of 6 hours) and remove the lenses during the waking hours. The subject will be examined at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after dispensing to evaluate the ocular physiology and the treatment effect. The target refractive error (sphere) will be plano for all subjects. All subjects enrolled at two of the investigational sites (targeted total of 40 subjects) will be evaluated for the stability of UCVA and manifest refraction throughout a single day on or following the 3 month, 6 month, or 9 month follow up visits. A post-treatment follow-up visit will be scheduled 1 month following discontinuation of the study lens. When it has been determined that no additional follow up visits are required, the subject will be discharged from the study.