Clinical trial NCT06009458: Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Official title: Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: orthokeratology
contact lens
Acuity
Overnight
myopia
myopic
astigmatism
astigmatic
Lead sponsor: Acuity Polymers, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 387
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Is willing and able to follow participant instructions for product usage and meet the specified schedule of follow-up visits;
3. 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.
4. Has a best spectacle corrected visual acuity of 0.04 log MAR (20/20 -2) or better in each eye;
5. 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.

Exclusion Criteria:

1. Is pregnant, breast-feeding or intends to become pregnant over the course of the study.
2. 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.
3. Is a potential pediatric subject that is a ward of the State or any other agency, institution, or entity.
4. 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.
5. 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.
6. Has evidence of keratoconus, corneal irregularity, or abnormal video-keratography in either eye.
7. Has a pupil size greater than 6.0 mm in photopic illumination as measured with pupil detection component of computer assisted video keratography.
8. Has a corneal diameter of 10 mm or less;
9. Has flat keratometry values flatter than 38.00D (8.88 mm), or steeper than 47.00D (7.16 mm);
10. Takes medication that may cause dry eye or affect vision, corneal curvature, or healing (i.e., corticosteroids);
11. Has an allergy to any ingredient in the study lens care solutions;
12. Has significant ocular allergy, which would contraindicate solution use and/or "normal" contact lens wear;
13. Is currently using or has a history of atropine use for myopia progression control
14. 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;
15. Is participating in any other type of clinical or research study.

Primary outcomes:
measure: Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
timeFrame: 1 year
measure: Attempted vs. Achieved Reduction in manifest refractive error
timeFrame: 1 Year
measure: Proportion of eyes achieved UCVA of ≤0.30 logMAR , ≤0.20 logMAR ,≤0.10 logMAR, and ≤0.00 logMAR
timeFrame: 1 Year
measure: Treatment stability
timeFrame: 1 Year
measure: Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit
timeFrame: 1 Year
measure: Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
timeFrame: 1 Year
measure: All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
timeFrame: 1 Year
measure: 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).
timeFrame: 1 Year
Secondary outcomes:
measure: 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.
timeFrame: 1 Year
measure: Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group.
timeFrame: 1 Year
measure: 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)
timeFrame: 1 Year
measure: 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)
timeFrame: 1 Year
measure: Corneal topography changes (in simulated keratometry flat and steep meridia) from baseline to 12-month post-dispensing visit (overall and stratified by baseline sphere).
timeFrame: 1 Year
measure: An analysis of corneal topography for changes in eccentricity from baseline to 12-month visit
timeFrame: 1 Year
measure: An analysis of change in absolute corneal astigmatism from baseline to 12-month visit
timeFrame: 1 Year
measure: Number of discontinued subjects and the reasons of discontinuation.
timeFrame: 1 Year
measure: An analysis of the relationship between changes in simulated keratometry and corresponding reductions in manifest sphere at all scheduled visits (1 month and later).
timeFrame: 1 Year
measure: Number and rates of average wear time per day at all scheduled visits (1 day and later)
timeFrame: 1 Year
measure: An analysis of the effects of wearing time on uncorrected visual acuity (UCVA) at all visits (1 month and later)
timeFrame: 1 Year
measure: 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.
timeFrame: 1 Year
measure: 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.
timeFrame: 1 Year
measure: Increase in corneal/refractive astigmatism of 2D or more and 1D or more post-treatment as compared to baseline
timeFrame: 1 Year
measure: Signs/symptoms and complications from subjective questionnaires and reported during the study
timeFrame: 1 Year
measure: 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.
timeFrame: 1 Year
measure: Descriptive statistics of specular microscopy measurements for percent change from baseline of specular microscopy measurements will be provided at 12-month visit
timeFrame: 1 Year
measure: 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
timeFrame: 1 Year
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Advanced Optometry of Mission Viejo
state: California
city: Oakland
country: United States
facility: Elsa Pao, O.D. Optometrist
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Sunnyvale
country: United States
facility: Silicon Valley Eye Physicians
state: California
city: Ocoee
country: United States
facility: Coan Eye Care
state: Florida
city: New York
country: United States
facility: Center for Ophthalmic and Vision Research, LLC
state: New York
city: Pittsford
country: United States
facility: Reed Eye Associates
state: New York
city: Bellaire
country: United States
facility: Bellaire Family Eye Care
state: Texas
city: Houston
country: United States
facility: Queenston Eye Care
state: Texas
city: Adelaide
country: Australia
facility: Innovative Eye Care
city: Cooks Hill
country: Australia
facility: Custom Eyecare Newcastle
city: Southport
country: Australia
facility: Eyeconic Optometry
city: Hamilton
country: New Zealand
facility: Rose Optometry
Study officials:
affiliation: Andre Vision and Device Research
name: Mijeong Kwon Andre, MS
role: STUDY_DIRECTOR
References: