Visual AcuityNCT05141448

Visual Performance of Soft Contact Lenses With Myopia Control Optics

A study testing 1-Day Acuvue Moist, EMO-118 and EMO-114 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

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 multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period. Read more about this study

Who is it for?: Ages 7 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: 1-Day Acuvue Moist, EMO-118 and EMO-114
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 22 Nov 2021to 1 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 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:
Read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy of the form.
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).
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 7 and 17 (inclusive) years of age at the time of screening.
By self-report, habitually wear soft contact lenses or be a current non-contact lens wearer interested in soft lens wear.

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The non-vertex corrected best sphere distance refraction must be between -1.00 D and -4.50 D (inclusive) in each eye.
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.
The distance visual acuity with best sphere distance correction must be 20/25 or better in each eye.
Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes.
Have 20/40 or better vision in each eye with wearable spectacles or uncorrected.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Be currently pregnant or lactating.
Be diabetic.
Be currently using any ocular medications. Lubricants (artificial tears) eyedrops are allowed.
Have any current ocular infection of any type.
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.

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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.
Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 30 days.
Be currently wearing lenses in an extended wear modality.
Be currently wearing soft contact lenses for astigmatism in either eye.
Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
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.
Children who are wards of the State or any other agency, institution, or entity.
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.
Have grade 3 or greater palpebral conjunctival observations or any other grade 2 slit lamp findings on the ISO 11980 classification scale.
Have strabismus (intermittent or constant) or amblyopia.
Have a history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
Have any central corneal scar.
Have a pupil diameter under bright illumination of less than 2 mm in either eye.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vision Optique
Houston, Texas, 77005

Other trials in United States

About this study

This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.

Conditions: Visual Acuity
Being tested: 1-Day Acuvue Moist, EMO-118, EMO-114, MiSight® 1 day

What participants receive

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

1-Day Acuvue MoistDevice
Run-in Contact Lens
EMO-118Device
Test Lens1
EMO-114Device
Test Lens2
MiSight® 1 dayDevice
Control Lens

Study groups in NCT05141448
Study group	Role	What they receive
Test1/Test2/Control	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Test2/Control. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day
Test1/Control/Test2	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Control/Test2. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day
Test2/Test1/Control	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Test1/Control. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day
Test2/Control /Test1	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Control /Test1. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day
Control/Test1/Test2	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test1/Test2. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day
Control/Test2/Test1	Experimental	Eligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test2/Test1. Receives: Device: 1-Day Acuvue Moist; Device: EMO-118; Device: EMO-114; Device: MiSight® 1 day

What is being measured

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

Binocular Visual Performance (LogMAR)
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.
Measured: Up to 2-Week Follow-up

Timeline

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

22 Nov 20211 Apr 2022

First posted2 Dec 2021
Study start22 Nov 2021
Primary completion1 Apr 2022
Study completion1 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Visual AcuityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05141448
Sponsor's protocol ID: CR-6457
Status last verified: Apr 2025
First submitted: 19 Nov 2021
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment
Active, not recruiting
Mean Visual Acuity Changes Following Five Injections of Aflibercept
Diabetic Macular Edema
Not yet recruitingPhase 3
Study With Batten-1 (Miglustat Liquid Formulation) to Treat Ceroid Lipofuscinosis Neuronal 3 (CLN3) Disease
CLN3
Recruiting
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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Visual Performance of Soft Contact Lenses With Myopia Control Optics
ClinicalTrials.gov ID: NCT05141448
Acronym / sponsor ID: CR-6457
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 22 Nov 2021 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 2 Dec 2021 (actual)
Results: Posted 8 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Test1/Test2/Control	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Test2/Control.
Test1/Control/Test2	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test1/Control/Test2.
Test2/Test1/Control	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Test1/Control.
Test2/Control /Test1	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Test2/Control /Test1.
Control/Test1/Test2	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test1/Test2.
Control/Test2/Test1	Experimental	Device: 1-Day Acuvue Moist, Device: EMO-118, Device: EMO-114, Device: MiSight® 1 dayEligible subjects will be fitted with the run-in lens for approximately one week, then randomized to the sequence Control/Test2/Test1.

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (11 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1-Day Acuvue MoistRun-in Contact Lens	Device	Control/Test1/Test2, Control/Test2/Test1, Test1/Control/Test2, Test1/Test2/Control, Test2/Control /Test1, Test2/Test1/Control
EMO-118Test Lens1	Device	Control/Test1/Test2, Control/Test2/Test1, Test1/Control/Test2, Test1/Test2/Control, Test2/Control /Test1, Test2/Test1/Control
EMO-114Test Lens2	Device	Control/Test1/Test2, Control/Test2/Test1, Test1/Control/Test2, Test1/Test2/Control, Test2/Control /Test1, Test2/Test1/Control
MiSight® 1 dayControl Lens	Device	Control/Test1/Test2, Control/Test2/Test1, Test1/Control/Test2, Test1/Test2/Control, Test2/Control /Test1, Test2/Test1/Control

Primary outcome

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.

Results and safety

Results posted to the registry on 8 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-in Lens/Test 2/Test 1/Control	13	13
Run-in Lens/Test 2/Control/Test 1	13	12
Run-in Lens/Test 1/Test 2/Control	15	15
Run-in Lens/Test 1/Control/Test 2	12	12
Run-in Lens/Control/Test 2/Test 1	11	10
Run-in Lens/Control/Test1/Test2	11	11

Primary outcome: Binocular Visual Performance (LogMAR)

Time frame: Up to 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Run-in: Etafilcon A n = 49	Senofilcon A C3 (EMO-114) [Test 2] n = 49	Senofilcon A C3 (EMO-118) [Test 1] n = 49	Omafilcon A (MS1D) [Control] n = 49
Value	-0.10 (0.057)	-0.10 (0.063)	-0.07 (0.064)	-0.11 (0.059)

Senofilcon A C3 (EMO-118) [Test 1] vs Omafilcon A (MS1D) [Control]: Mean Difference (Final Values): 0.04 (95% CI 0.02 to 0.06), Linear Mixed Model

Population analysed: All subjects who successfully completed all study visits without a major protocol deviation.

Adverse events

Time frame: Throughout the duration of the study. Approximately 2 months per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-in: Etafilcon A	0 of 75 (0%)	0 of 75 (0%)	0 of 75
Senofilcon A C3 (EMO-114)	0 of 69 (0%)	0 of 69 (0%)	0 of 69
Senofilcon A C3 (EMO-118)	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Omafilcon A	0 of 69 (0%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

Related trials for Visual Acuity

RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 1-Day Acuvue Moist, EMO-118 and EMO-114 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

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 19 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 27 Apr 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Binocular Visual Performance (LogMAR) (time frame: Up to 2-Week Follow-up). 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 NCT05141448.

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 27 Apr 2025.