Overnight Orthokeratology Lenses for Near-Sightedness (Acuity200OK Trial)

N/A

Waitlist Available

Research Sponsored by Acuity Polymers, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is to collect safety & effectiveness data on a contact lens for overnight wear that can be submitted to the FDA to get approval.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort while wearing the lenses, redness or infection of the eyelids or conjunctiva (the white part of the eye), corneal staining which could indicate damage to the front surface of the eye, dry eyes, visual disturbances such as glare or halos around lights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment

Attempted vs. Achieved Reduction in manifest refractive error

Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)

+5 more

Secondary study objectives

A level of attempted versus achieved reduction in manifest refractive error- proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano) at all other visits (1 month or later)

A set of descriptive statistics of improvement of monocular UCVA at all visits (1 month or later), as well as stratified by baseline sphere and by spherical equivalent.

An analysis of change in absolute corneal astigmatism from baseline to 12-month visit

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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