Overnight Orthokeratology Lenses for Near-Sightedness
(Acuity200OK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a special type of contact lens called the Acuity 200™ Orthokeratology Lens, designed for overnight wear to assist with near-sightedness (difficulty seeing distant objects). Researchers aim to assess the safety and effectiveness of these lenses to seek approval from the U.S. Food and Drug Administration. Participants must wear the lenses nightly and attend regular check-ups. Individuals with naturally occurring myopia between -0.75 to -6.00 diopters, without eye diseases or major vision problems, may be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could enhance vision correction options.
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 prior data suggests that the Acuity 200™ Orthokeratology Contact Lens is safe for overnight wear?
Research shows that overnight orthokeratology lenses, such as the Acuity 200™ (fluoroxyfocon A), are generally safe for correcting nearsightedness. Studies have not identified any serious problems with these lenses. Users reshaping their eyes while sleeping have not reported major issues. Some minor discomfort, like dry eyes or mild irritation, might occur, but these are usually temporary and manageable. Ongoing research aims to ensure these lenses remain safe over the long term.12345
Why are researchers excited about this trial?
Researchers are excited about Acuity 200™ because it offers a non-surgical, overnight solution to correct near-sightedness, which is different from traditional daytime contact lenses or glasses. Unlike standard options, this orthokeratology lens reshapes the cornea while you sleep, potentially reducing the need for corrective lenses during the day. This method is particularly appealing because it is non-invasive and offers a temporary, adjustable approach to vision correction without the permanence or risks associated with refractive surgery.
What evidence suggests that the Acuity 200™ Orthokeratology Contact Lens is effective for near-sightedness?
Research shows that orthokeratology lenses, such as the Acuity 200™ used in this trial, can correct near-sightedness during sleep. These lenses gently reshape the cornea (the clear front part of the eye) overnight, allowing clear vision during the day without glasses or contacts. Studies have found that similar lenses provide clear daytime vision and are safe for overnight use. Evidence from users of orthokeratology lenses indicates noticeable improvements in vision for those who are near-sighted. While specific data on the Acuity 200™ lens is still being collected, the overall success of orthokeratology suggests it could be effective.12345
Who Is on the Research Team?
Mijeong Kwon Andre, MS
Principal Investigator
Andre Vision and Device Research
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acuity Polymers, Inc.
Lead Sponsor
Citations
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact ...
The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) ...
2.
ctv.veeva.com
ctv.veeva.com/study/acuity-200-fluoroxyfocon-a-orthokeratology-contact-lens-for-overnight-wearAcuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens ...
The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ ...
Overnight Orthokeratology Lenses for Near-Sightedness · ...
Trial Overview The Acuity 200™ Orthokeratology Contact Lens is being tested for safety and effectiveness in correcting near-sightedness during overnight wear.
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for ...
The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) ...
Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP ...
The objective of this clinical investigation is to collect valid scientific safety and effectiveness data on the Acuity 200 (fluoroxyfocon A) Rigid Gas ...
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