Visual Performance of Soft Contact Lenses With Myopia Control Optics

April 24, 2025 updated by: Johnson & Johnson Vision Care, Inc.
This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77005
        • Vision Optique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. 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. Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information).
    3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    4. Be between 7 and 17 (inclusive) years of age at the time of screening.
    5. By self-report, habitually wear soft contact lenses or be a current non-contact lens wearer interested in soft lens wear.
    6. The non-vertex corrected best sphere distance refraction must be between -1.00 D and -4.50 D (inclusive) in each eye.
    7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be less than or equal to 0.75 D (inclusive) in each eye with any degree of axis.
    8. The distance visual acuity with best sphere distance correction must be 20/25 or better in each eye.
    9. Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes.

    10. Have 20/40 or better vision in each eye with wearable spectacles or uncorrected.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Be currently pregnant or lactating.
    2. Be diabetic.
    3. Be currently using any ocular medications. Lubricants (artificial tears) eyedrops are allowed.
    4. Have any current ocular infection of any type.
    5. Have any systemic disease (e.g., Sjogren'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, a history of serious mental illness or seizures, or other diseases, by parent or legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study.
    6. Use of systemic medication (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. See section 9.1 for additional details regarding excluded systemic medications.
    7. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 30 days.
    8. Be currently wearing lenses in an extended wear modality.
    9. Be currently wearing soft contact lenses for astigmatism in either eye.
    10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
    11. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
    12. Children who are wards of the State or any other agency, institution, or entity.
    13. Have 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 is not limited to, entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis.
    14. Have grade 3 or greater palpebral conjunctival observations or any other grade 2 slit lamp findings on the ISO 11980 classification scale.
    15. Have strabismus (intermittent or constant) or amblyopia.
    16. Have a history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
    17. Have any central corneal scar.
    18. Have a pupil diameter under bright illumination of less than 2 mm in either eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test1/Test2/Control
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Test2/Control.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens
Experimental: Test1/Control/Test2
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Control/Test2.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens
Experimental: Test2/Test1/Control
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Test1/Control.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens
Experimental: Test2/Control /Test1
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Control /Test1.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens
Experimental: Control/Test1/Test2
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test1/Test2.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens
Experimental: Control/Test2/Test1
Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test2/Test1.
Device: 1-Day Acuvue Moist
Run-in Contact Lens
Device: EMO-118
Test Lens1
Device: EMO-114
Test Lens2
Device: MiSight® 1 day
Control Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular Visual Performance (LogMAR)
Time Frame: Up to 2-Week Follow-up
Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit.
Up to 2-Week Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Vision Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-6457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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