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Visual AcuityNCT05634408

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

A study testing ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
24 Dec 2022to 20 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hainan Boao Lecheng AIER Eye Hospital Co. LTD

    Qionghai, Hainan, 571400

Other trials in China

About this study

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.

Conditions
Visual Acuity
Being tested
ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)Device

    TEST Lens

Study groups in NCT05634408
Study groupRoleWhat they receive
TEST LensExperimentalEligible subjects will bilaterally wear the TEST Lens for the duration of the study.
Receives: Device: ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Axial Length (AL) from baseline

    AL will be measured, in mm, every 6 months throughout the study using an ocular biometer.

    Measured: Up to 24-month follow-up

  2. 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.

    Measured: up to 24-month follow-up

  3. 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.

    Measured: up to 24-month follow-up

Secondary outcomes (1)

  1. 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.

    Measured: up to 24-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start24 Dec 2022
  3. Primary completion20 Aug 2025
  4. Study completion20 Aug 2025

Resources

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634408
Sponsor's protocol ID
CR-6499
Status last verified
Jan 2026
First submitted
22 Nov 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A study testing ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in China.

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 11 inclusion and 27 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Axial Length (AL) from baseline (time frame: Up to 24-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634408.

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 16 Jan 2026.

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