An interventional study of Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear in Myopia, sponsored by Acuity Polymers, Inc.. Active, not recruiting at 13 sites in 3 countries. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Acuity Polymers, Inc. · Not applicable, Interventional, and Treatment
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).
Orthokeratology is an alternative method to correct refractive errors using individually designed gas permeable (rigid) lenses worn overnight to temporarily modify the curvature of cornea. Modern orthokeratology technology uses highly permeable rigid lens material and dynamic reverse geometry designs to allow faster and more effective corneal reshaping. Acuity 200™ (fluoroxyfocon A) is a stable material with relatively higher oxygen permeability compared to other marketed gas permeable materials. The clinical effects of wearing contact lenses that limit oxygen supply have been extensively reported with potential complications related to hypoxia including corneal swelling, epithelial microcysts, limbal hyperemia, corneal vascularization, refractive error changes and corneal distortion. Given the significantly higher oxygen permeability characteristics of Acuity 200™ (fluoroxyfocon A) relative to currently FDA approved orthokeratology materials, the material is well-suited for overnight wear applications-such as orthokeratology, when the eye is subject to hypoxic conditions during sleep.
The objective of the clinical investigation (AVDR 2022-01) 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 the 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). The hypothesis is that the primary and secondary outcomes for safety and effectiveness are consistent with currently marketed devices approved by the FDA for overnight orthokeratology.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 387 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Acuity Polymers, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Device: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Acuity 200™ Orthokeratology Contact Lenses are intended to be worn overnight with removal during following day. The lenses are designed to produce a temporary reduction of myopia by reversibly altering the curvature of the cornea. The lenses are manufactured from fluoroxyfocon A, which is a gas permeable contact lens material composed of a siloxanyl fluoromethacrylate copolymer. The material name fluoroxyfocon A is registered with United States Adopted Name (USAN).The Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens is available in spherical, asymmetrical, aspheric, and tangential lens designs to best fit the individual cornea, using corneal topography and/or diagnostic lenses.
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
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) .
Time frame: 1 year
Attempted vs. 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 the 12-month post-dispensing visit (overall and stratified by baseline sphere). 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) .
Time frame: 1 Year
Proportion of eyes achieved UCVA of ≤0.30 logMAR , ≤0.20 logMAR ,≤0.10 logMAR, and ≤0.00 logMAR
Proportion of eyes at the 1-month visit (and later visit intervals) that have achieved UCVA of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR for the whole cohort and stratified by pre-treatment refractive bin. 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), and22 years and older (adults) .
Time frame: 1 Year
Treatment stability
Treatment stability as measured by the percentage of eyes that change by less than ±0.50 diopters manifest refraction spherical equivalent (MRSE) between two consecutive visits (baseline and 1-month, 1 and 3-month, 3 and 6-month, 6 and 9-month, and 9 and 12-month) 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) .
Time frame: 1 Year
Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit
Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit. The primary safety 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).
Time frame: 1 Year
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events. The primary safety 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).
Time frame: 1 Year
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment. The primary safety 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).
Time frame: 1 Year
Number and rate of cases of loss from baseline to any post-dispensing visit of: monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
Number and rate of cases of loss from baseline to any post-dispensing visit of: monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar). The primary safety 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).
Time frame: 1 Year
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.
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.
Time frame: 1 Year
Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group.
Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group.
Time frame: 1 Year
Pre-treatment manifest sphere in comparison to post-treatment manifest sphere stratified by dioptric power for all completed subjects at the 1 month visit and later visit intervals (3, 6, 9, and 12 month visits)
Pre-treatment manifest sphere in comparison to post-treatment manifest sphere stratified by dioptric power for all completed subjects at the 1 month visit and later visit intervals (3, 6, 9, and 12 month visits)
Time frame: 1 Year
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 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) (overall and stratified by baseline sphere).
Time frame: 1 Year
Corneal topography changes (in simulated keratometry flat and steep meridia) from baseline to 12-month post-dispensing visit (overall and stratified by baseline sphere).
Corneal topography changes (in simulated keratometry flat and steep meridia) from baseline to 12-month post-dispensing visit (overall and stratified by baseline sphere).
Time frame: 1 Year
An analysis of corneal topography for changes in eccentricity from baseline to 12-month visit
An analysis of corneal topography for changes in eccentricity from baseline to 12-month visit
Time frame: 1 Year
An analysis of change in absolute corneal astigmatism from baseline to 12-month visit
An analysis of change in absolute corneal astigmatism from baseline to 12-month visit
Time frame: 1 Year
Number of discontinued subjects and the reasons of discontinuation.
Number of discontinued subjects and the reasons of discontinuation.
Time frame: 1 Year
An analysis of the relationship between changes in simulated keratometry and corresponding reductions in manifest sphere at all scheduled visits (1 month and later).
An analysis of the relationship between changes in simulated keratometry and corresponding reductions in manifest sphere at all scheduled visits (1 month and later).
Time frame: 1 Year
Number and rates of average wear time per day at all scheduled visits (1 day and later)
Number and rates of average wear time per day at all scheduled visits (1 day and later).
Time frame: 1 Year
An analysis of the effects of wearing time on uncorrected visual acuity (UCVA) at all visits (1 month and later)
An analysis of the effects of wearing time on uncorrected visual acuity (UCVA) at all visits (1 month and later).
Time frame: 1 Year
Stability of monocular UCVA change by post-lens removal hours for the sub-group of up to 40 participants at a single day visit (at 3-month or any later visits) - stratified by baseline MRSE.
Stability of monocular UCVA change by post-lens removal hours for the sub-group of up to 40 participants at a single day visit (at 3-month or any later visits) - stratified by baseline MRSE.
Time frame: 1 Year
Stability of manifest refractive spherical equivalent (MRSE) change by post-lens removal hours for the sub-group of up to 40 participants at a single day visit (at 3-month or any later visits) - stratified by baseline MRSE.
Stability of manifest refractive spherical equivalent (MRSE) change by post-lens removal hours for the sub-group of up to 40 participants at a single day visit (at 3-month or any later visits) - stratified by baseline MRSE.
Time frame: 1 Year
Increase in corneal/refractive astigmatism of 2D or more and 1D or more post-treatment as compared to baseline
Increase in corneal/refractive astigmatism of 2D or more and 1D or more post-treatment as compared to baseline.
Time frame: 1 Year
Signs/symptoms and complications from subjective questionnaires and reported during the study
Signs/symptoms and complications from subjective questionnaires and reported during the study.
Time frame: 1 Year
Descriptive statistics of IOP (Interocular Pressure) and for percent change from baseline of IOP value will be provided at 6-month, 12-month, and post-treatment 1-month visit.
Descriptive statistics of IOP (Interocular Pressure) and for percent change from baseline of IOP value will be provided at 6-month, 12-month, and post-treatment 1-month visit.
Time frame: 1 Year
Descriptive statistics of specular microscopy measurements for percent change from baseline of specular microscopy measurements will be provided at 12-month visit
Descriptive statistics of specular microscopy measurements ( Endothelial Cell Morphology Analysis (Cell density (cells/mm2), Polymegathism (CV) and Pleomorphism (percentage of hexagonal cells)) and for percent change from baseline of specular microscopy measurements will be provided at 12-month visit.
Time frame: 1 Year
Descriptive statistics of central corneal thickness (micron) and for percent change from baseline of central corneal thickness will be provided for post-dispensing visits at 3-month, 12-month and post-treatment 1-month visits
Descriptive statistics of central corneal thickness (micron) and for percent change from baseline of central corneal thickness will be provided for post-dispensing visits at 3-month, 12-month and post-treatment 1-month visits.
Time frame: 1 Year
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Acuity Polymers, Inc.