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

NCT06009458 | Active Not Recruiting FDA Device

• 1 other identifier: AVDR 2022-01
• Study Type: interventional
• Target: 387
• Locations: 3 countries
• Sites: 13

Brief 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. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).

Conditions

Myopia

Keywords

orthokeratology; contact lens; Acuity; Overnight; myopia; myopic; astigmatism; astigmatic

Outcome Measures

Primary Outcomes (8)

• 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) .

  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) .

  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) .

  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) .

  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).

  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).

  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).

  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).

  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.

  1 Year

• Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group.

  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)

  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)

  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).

  1 Year

Study Arms (1)

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.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Acuity Polymers, Inc.: lead

Study Sites (13)

Advanced Optometry of Mission Viejo

Mission Viejo, California, 92691, United States

Location

Elsa Pao, O.D. Optometrist

Oakland, California, 94607, United States

Location

Pacific Rims Optometry

San Francisco, California, 94127, United States

Location

Silicon Valley Eye Physicians

Sunnyvale, California, 94087, United States

Location

Coan Eye Care

Ocoee, Florida, 34761, United States

Location

Center for Ophthalmic and Vision Research, LLC

New York, New York, 10022, United States

Location

Reed Eye Associates

Pittsford, New York, 14534, United States

Location

Bellaire Family Eye Care

Bellaire, Texas, 77401, United States

Location

Queenston Eye Care

Houston, Texas, 77095, United States

Location

Innovative Eye Care

Adelaide, 5000, Australia

Location

Custom Eyecare Newcastle

Cooks Hill, 2300, Australia

Location

Eyeconic Optometry

Southport, 4215, Australia

Location

Rose Optometry

Hamilton, 3204, New Zealand

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mijeong Kwon Andre, MS

  Andre Vision and Device Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: August 24, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

NZ (1); US (9); AU (3)