Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Study Overview
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Brief Summary
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This is a single-site, prospective, single-arm, open-label, real-world evidence study with a minimal study duration of 1-year, up to 2-year follow-up to evaluate overall visual acuity.

Official Title
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Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject's parents or legal guardians must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). The subject must read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Between 7 and 12 (inclusive) years of age at the time of screening. Be of Chinese ethnicity, which is defined as with both biological parents being of Chinese ethnicity). Have normal eyes (i.e., no ocular medications or infections of any type). Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye. Have refractive cylinder in the range of 0.00 D to 1.00 D (inclusive) in each eye with any degree of axis, by subjective sphero-cylindrical refraction. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (4.95 in China standard 5-point logMAR scoring convention) or better in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between the two eyes is less than 0.20 logMAR (0.2 points difference in China standard 5-point logMAR scoring convention). Spherical equivalent power of cycloplegic objective spherocylindrical refraction (by auto refraction) between -0.75 D and -4.50 D (inclusive) and cylinder power of 1.00 D or less in each eye (based on the average of 5 repeated sphero-cylindrical refraction measures and rounded to the nearest 1/8 D). The difference in spherical equivalent power between the two eyes be less than or equal to 1.50 D (based on the average of 5 repeated sphero-cylindrical refraction measures and rounded to the nearest 1/8 D). Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), any underlying medical condition that makes subjects at risk of severe COVID complications, or other diseases, by parent of legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. See Section 9 for additional details regarding excluded systemic medications. Any current use of ocular medication (occasional use of re-wetting drops is allowed). Chronic or seasonal use of ophthalmic topical medication that are specified as disallowed medications in Section 9 of the protocol. Chronic use of any topical antimuscarinic agents for any reason. Recent temporary use (within 21 days from enrollment) of topical agents with anti-muscarinic properties. This includes but is not limited to scopolamine, pirenzepine, tropicamide, cyclopentolate and homatropine. Any known hypersensitivity or allergic reaction to cyclopentolate, topical anesthetics or Sponsor approved rewetting drop solutions available in local markets. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. History of myopia control treatment or participation in any prior myopia control clinical study in the test group with an optical intervention for more than 2 weeks. This includes but is not limited to orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal or other novel contact or spectacles lenses). History of myopia control treatment or participation in any prior myopia control clinical study in the test group with any pharmacological intervention (e.g., atropine or pirenzepine). Current or recent (within 60 days from enrollment) wear of orthokeratology lenses, bifocal, multifocal contact lenses or bifocal, multifocal spectacles. Be current or recent (within 30 days from enrollment) rigid lens wearers. Be immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear or subjects' participation in the study. Any central corneal scar. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear. Binocular vision abnormality, intermittent strabismus or strabismus. Anterior chamber angle is Grade 2 or narrower in either eye. Intraocular pressure (IOP) is higher than 21 mmHg in either eye Pupil diameter under bright illumination is less than 2 mm in either eye. Pupil pathology. Fundus pathology. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST Lens<br>Eligible subjects will bilaterally wear the TEST Lens for the duration of the study. | Device: ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)<br>* TEST Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Axial Length (AL) from baseline | AL will be measured, in mm, every 6 months throughout the study using an ocular biometer. | Up to 24-month follow-up | 
| Change in Spherical Equivalent of Cycloplegic Autorefraction (SECAR) from baseline | SECAR will be measured, in diopter (D), every 6 months throughout the study using an autorefractor. | up to 24-month follow-up | 
| Serious and significant ocular adverse events (AEs) | Number (n, %) of subjects and eyes with contact lens related (i.e., related and possibly related) serious and significant ocular adverse events (AEs) by diagnosis. | up to 24-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance LogMAR Visual Acuity | Monocular and binocular distance visual acuity will be measured at distance 4 meters under high luminance (120-200 cd/m2), high contrast (>600 lux) conditions using Landolt C logMAR visual acuity. | up to 24-month follow-up |