Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

387 Participants Needed

Overnight Orthokeratology Lenses for Near-Sightedness
(Acuity200OK Trial)

Recruiting at 13 trial locations

Overseen ByBret Andre

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Acuity Polymers, Inc.

Must not be taking: Corticosteroids, Atropine

Disqualifiers: Pregnancy, Diabetes, Glaucoma, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you take medication that may cause dry eye or affect vision, corneal curvature, or healing, such as corticosteroids.

What data supports the effectiveness of the treatment Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear for near-sightedness?

Research on similar orthokeratology lenses, like the Emerald Contact Lens, shows they are effective in reducing myopia (near-sightedness) in children when worn overnight. This suggests that Acuity 200™ lenses may also be effective for this purpose.¹ ² ³ ⁴ ⁵

Is it safe to use overnight orthokeratology lenses for near-sightedness?

Research shows that overnight orthokeratology lenses are generally safe for correcting near-sightedness, with no severe complications observed in studies. However, issues can occur if proper hygiene and care are not maintained.¹ ⁵ ⁶ ⁷ ⁸

How does the Acuity 200™ Orthokeratology Contact Lens treatment for near-sightedness differ from other treatments?

The Acuity 200™ Orthokeratology Contact Lens is unique because it is worn overnight to temporarily reshape the cornea, reducing the need for glasses or daytime contact lenses. This treatment offers a non-surgical option for correcting near-sightedness, with effects that are reversible and typically stabilize after a week of use.¹ ² ³ ⁹ ¹⁰

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).

Research Team

Mijeong Kwon Andre, MS

Principal Investigator

Andre Vision and Device Research

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

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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

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the Acuity 200™ Orthokeratology Contact Lens overnight for a minimum of 6 hours and are examined at various intervals to evaluate ocular physiology and treatment effect.

12 months

Visits at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a post-treatment follow-up visit scheduled 1 month following discontinuation of the study lens.

1 month

1 visit (in-person)

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

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.