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Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management | Clinical Trials | Clareo Health

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

NCT05634408•Johnson & Johnson Vision Care, Inc.

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.

Eligibility

Age

7 - 12 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•1. 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.
•2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•3. Between 7 and 12 (inclusive) years of age at the time of screening.
•4. Be of Chinese ethnicity, which is defined as with both biological parents being of Chinese ethnicity).
•5. Have normal eyes (i.e., no ocular medications or infections of any type).
•6. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.
•7. 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.
•8. 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).
•9. 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).
+1 more criteria

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•1. 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.
•2. 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.
•3. Any current use of ocular medication (occasional use of re-wetting drops is allowed).
•4. Chronic or seasonal use of ophthalmic topical medication that are specified as disallowed medications in Section 9 of the protocol.
•5. Chronic use of any topical antimuscarinic agents for any reason.
•6. 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.
•7. Any known hypersensitivity or allergic reaction to cyclopentolate, topical anesthetics or Sponsor approved rewetting drop solutions available in local markets.
•8. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
•9. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
+17 more criteria

Locations (1)

Hainan Boao Lecheng AIER Eye Hospital Co. LTD

Qionghai, Hainan, China

Key Dates

Start Date

December 24, 2022

Primary Completion Date

August 20, 2025

Completion Date

August 20, 2025

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Visual Acuity

Interventions

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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