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

Primary Purpose

Visual Acuity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Acuity

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hainan Boao Lecheng AIER Eye Hospital Co. LTDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TEST Lens

Arm Description

Eligible subjects will bilaterally wear the TEST Lens for the duration of the study.

Outcomes

Primary Outcome Measures

Change in Axial Length (AL) from baseline
AL will be measured, in mm, every 6 months throughout the study using an ocular biometer.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2022
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05634408
Brief Title
Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management
Official Title
Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEST Lens
Arm Type
Experimental
Arm Description
Eligible subjects will bilaterally wear the TEST Lens for the duration of the study.
Intervention Type
Device
Intervention Name(s)
ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management (A1D)
Intervention Description
TEST Lens
Primary Outcome Measure Information:
Title
Change in Axial Length (AL) from baseline
Description
AL will be measured, in mm, every 6 months throughout the study using an ocular biometer.
Time Frame
Up to 24-month follow-up
Title
Change in Spherical Equivalent of Cycloplegic Autorefraction (SECAR) from baseline
Description
SECAR will be measured, in diopter (D), every 6 months throughout the study using an autorefractor.
Time Frame
up to 24-month follow-up
Title
Serious and significant ocular adverse events (AEs)
Description
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.
Time Frame
up to 24-month follow-up
Secondary Outcome Measure Information:
Title
Distance LogMAR Visual Acuity
Description
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.
Time Frame
up to 24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
1-800-843-2020
Email
anixon1@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Vision Care, Inc. Clinical Trial
Organizational Affiliation
Johnson & Johnson Vision Care, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hainan Boao Lecheng AIER Eye Hospital Co. LTD
City
Qionghai
State/Province
Hainan
ZIP/Postal Code
571400
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
http://yoda.yale.edu

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

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