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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06009458




Registration number
NCT06009458
Ethics application status
Date submitted
6/04/2023
Date registered
24/08/2023
Date last updated
24/08/2023

Titles & IDs
Public title
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Scientific title
Clinical Evaluation of Safety and Effectiveness for Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Secondary ID [1] 0 0
AVDR 2022-01
Universal Trial Number (UTN)
Trial acronym
Acuity200OK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

Other: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear - 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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Attempted vs. Achieved Reduction in manifest refractive error
Timepoint [2] 0 0
1 Year
Primary outcome [3] 0 0
Proportion of eyes achieved UCVA of =0.30 logMAR , =0.20 logMAR ,=0.10 logMAR, and =0.00 logMAR
Timepoint [3] 0 0
1 Year
Primary outcome [4] 0 0
Treatment stability
Timepoint [4] 0 0
1 Year
Primary outcome [5] 0 0
Number and rates (by type of event and relation to device) of serious and significant adverse events occurred at any visit
Timepoint [5] 0 0
1 Year
Primary outcome [6] 0 0
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
Timepoint [6] 0 0
1 Year
Primary outcome [7] 0 0
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
Timepoint [7] 0 0
1 Year
Primary outcome [8] 0 0
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).
Timepoint [8] 0 0
1 Year
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 Year
Secondary outcome [2] 0 0
Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group.
Timepoint [2] 0 0
1 Year
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
1 Year
Secondary outcome [5] 0 0
Corneal topography changes (in simulated keratometry flat and steep meridia) from baseline to 12-month post-dispensing visit (overall and stratified by baseline sphere).
Timepoint [5] 0 0
1 Year
Secondary outcome [6] 0 0
An analysis of corneal topography for changes in eccentricity from baseline to 12-month visit
Timepoint [6] 0 0
1 Year
Secondary outcome [7] 0 0
An analysis of change in absolute corneal astigmatism from baseline to 12-month visit
Timepoint [7] 0 0
1 Year
Secondary outcome [8] 0 0
Number of discontinued subjects and the reasons of discontinuation.
Timepoint [8] 0 0
1 Year
Secondary outcome [9] 0 0
An analysis of the relationship between changes in simulated keratometry and corresponding reductions in manifest sphere at all scheduled visits (1 month and later).
Timepoint [9] 0 0
1 Year
Secondary outcome [10] 0 0
Number and rates of average wear time per day at all scheduled visits (1 day and later)
Timepoint [10] 0 0
1 Year
Secondary outcome [11] 0 0
An analysis of the effects of wearing time on uncorrected visual acuity (UCVA) at all visits (1 month and later)
Timepoint [11] 0 0
1 Year
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
1 Year
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
1 Year
Secondary outcome [14] 0 0
Increase in corneal/refractive astigmatism of 2D or more and 1D or more post-treatment as compared to baseline
Timepoint [14] 0 0
1 Year
Secondary outcome [15] 0 0
Signs/symptoms and complications from subjective questionnaires and reported during the study
Timepoint [15] 0 0
1 Year
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
1 Year
Secondary outcome [17] 0 0
Descriptive statistics of specular microscopy measurements for percent change from baseline of specular microscopy measurements will be provided at 12-month visit
Timepoint [17] 0 0
1 Year
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
1 Year

Eligibility
Key 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.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Innovative Eye Care - Adelaide
Recruitment hospital [2] 0 0
Richard Lindsay and Associates - Balwyn North
Recruitment hospital [3] 0 0
Custom Eyecare Newcastle - Cooks Hill
Recruitment hospital [4] 0 0
Eyeconic Optometry - Southport
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3104 - Balwyn North
Recruitment postcode(s) [3] 0 0
2300 - Cooks Hill
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acuity Polymers, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06009458
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mijeong Kwon Andre, MS
Address 0 0
Andre Vision and Device Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James Bonafini
Address 0 0
Country 0 0
Phone 0 0
(585) 458-8409
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06009458