MyopiaAcuity200OKNCT06009458
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
A study testing Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear in people with Myopia, run by Acuity Polymers, Inc. at 13 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 1 Oct 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is age 7 or older with full legal capacity to volunteer or has parental or legal guardian written approval to volunteer; and has read, understood and signed the Informed Consent Form or Assent Form (for subjects 18 years and under);
- Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits;
- 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.
- Has a best spectacle corrected visual acuity of 0.04 log MAR (20/20 -2) or better in each eye;
- Is free of eye disease and binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) that may affect vision or contact lens wear; Has normal healthy eyes with no evidence of lid infection or structural abnormality; a conjunctiva free of infection; a cornea clear and free of edema, visually or topographically significant scars, clinically significant staining, significant vascularization, infiltrates when examined by slit-lamp biomicroscopy; and no evidence of iritis or uveitis.
Who cannot join
- Is pregnant, breast-feeding or intends to become pregnant over the course of the study.
- Is a potential pediatric subject that does not have the appropriate level of psychological maturity to comply with appropriate procedures needed for safe wear according to the investigator.
- Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity.
- Has a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, specifically excludes subjects from eligibility.
- Has a history of intraocular or corneal surgery (including cataract extraction and refractive surgery-such as Lasik), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye. NOTE: This includes any subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any subject with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
- Has evidence of keratoconus, corneal irregularity, or abnormal video-keratography in either eye.
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- Has a pupil size greater than 6.0 mm in photopic illumination as measured with pupil detection component of computer assisted video keratography.
- Has a corneal diameter of 10 mm or less;
- Has flat keratometry values flatter than 38.00D (8.88 mm), or steeper than 47.00D (7.16 mm);
- Takes medication that may cause dry eye or affect vision, corneal curvature, or healing (i.e., corticosteroids);
- Has an allergy to any ingredient in the study lens care solutions;
- Has significant ocular allergy, which would contraindicate solution use and/or "normal" contact lens wear;
- Is currently using or has a history of atropine use for myopia progression control
- Is a current wearer or previous wearer within the last 90 days of daily wear rigid gas permeable contact lenses, extended wear rigid gas permeable contact lenses, or orthokeratology contact lenses;
- Is participating in any other type of clinical or research study.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States9 sites
Bellaire Family Eye Care
Bellaire, Texas, 77401
Queenston Eye Care
Houston, Texas, 77095
Advanced Optometry of Mission Viejo
Mission Viejo, California, 92691
Center for Ophthalmic and Vision Research, LLC
New York, New York, 10022
Elsa Pao, O.D. Optometrist
Oakland, California, 94607
Coan Eye Care
Ocoee, Florida, 34761
Reed Eye Associates
Pittsford, New York, 14534
Pacific Rims Optometry
San Francisco, California, 94127
Silicon Valley Eye Physicians
Sunnyvale, California, 94087
Australia3 sites
Innovative Eye Care
Adelaide, 5000
Custom Eyecare Newcastle
Cooks Hill, 2300
Eyeconic Optometry
Southport, 4215
About this study
Official title: Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
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).
Read the detailed description
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.
- Conditions
- Myopia
- Being tested
- Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
- Keywords
- orthokeratology, contact lens, Acuity, Overnight, myopia, myopic, astigmatism, astigmatic
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear | Other | 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. Receives: Device: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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) .
Measured: 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) .
Measured: 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) .
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 Year
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 1 Year
Number of discontinued subjects and the reasons of discontinuation.
Number of discontinued subjects and the reasons of discontinuation.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Oct 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acuity Polymers, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mijeong Kwon Andre, MS, Study director, Andre Vision and Device Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009458
- Sponsor's protocol ID
- AVDR 2022-01
- Acronym
- Acuity200OK
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
- ClinicalTrials.gov ID
- NCT06009458
- Acronym / sponsor ID
- Acuity200OK / AVDR 2022-01
- Conditions
- Myopia
- Keywords
- orthokeratology, contact lens, Acuity, Overnight, myopia, myopic, astigmatism, astigmatic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Acuity Polymers, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear | Other | Device: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearFor 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Is age 7 or older with full legal capacity to volunteer or has parental or legal guardian written approval to volunteer; and has read, understood and signed the Informed Consent Form or Assent Form (for subjects 18 years and under);
- Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits;
- 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.
- Has a best spectacle corrected visual acuity of 0.04 log MAR (20/20 -2) or better in each eye;
- Is free of eye disease and binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) that may affect vision or contact lens wear; Has normal healthy eyes with no evidence of lid infection or structural abnormality; a conjunctiva free of infection; a cornea clear and free of edema, visually or topographically significant scars, clinically significant staining, significant vascularization, infiltrates when examined by slit-lamp biomicroscopy; and no evidence of iritis or uveitis.
Key exclusion criteria (15 listed)
- Is pregnant, breast-feeding or intends to become pregnant over the course of the study.
- Is a potential pediatric subject that does not have the appropriate level of psychological maturity to comply with appropriate procedures needed for safe wear according to the investigator.
- Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity.
- Has a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, specifically excludes subjects from eligibility.
- Has a history of intraocular or corneal surgery (including cataract extraction and refractive surgery-such as Lasik), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye. NOTE: This includes any subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any subject with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearAcuity 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. | Device | Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear |
Primary outcome
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
Time frame: 1 year
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) .
Attempted vs. Achieved Reduction in manifest refractive error
Time frame: 1 Year
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) .
Proportion of eyes achieved UCVA of ≤0.30 logMAR , ≤0.20 logMAR ,≤0.10 logMAR, and ≤0.00 logMAR
Time frame: 1 Year
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) .
Treatment stability
Time frame: 1 Year
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) .
Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit
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. 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).
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
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. 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).
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
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. 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).
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).
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). 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).
18 secondary outcomes
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.
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)
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)
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).
Time frame: 1 Year
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
Time frame: 1 Year
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).
Time frame: 1 Year
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)
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.
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.
Time frame: 1 Year
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
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.
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
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
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mijeong Kwon Andre, MS study director
Andre Vision and Device Research
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear in people with Myopia, run by Acuity Polymers, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.