Visual AcuityNCT03408444

Evaluating Soft Contact Lens Prototypes for Myopia Control

A study testing EMO-114, EMO-116 and EMO-118 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

Who is it for?: Ages 7 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: EMO-114, EMO-116 and EMO-118
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 27 Dec 2017to 25 May 2019
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 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 must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent 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 years of age (inclusive).
Have normal eyes (i.e., no ocular medications or infections of any type).

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Distance subjective best-sphere refraction must be between -0.75D and -4.50D (inclusive) in each eye.
Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 0.8 in decimal convention or 0.10 logMAR) or better in each eye.
Cycloplegic objective sphero-cylindrical refraction (by auto refraction) must be between -0.75D and -4.50D in sphere and is 1.00D or less in cylinder in each eye (based on the average of 5 repeated sphero-cylindrical refraction measures).
The difference in spherical equivalent power between the two eyes must be less than 1.50D (based on the average of 5 repeated sphero-cylindrical refraction measures).

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or lactating.
Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other systemic diseases (e.g., diabetes), by the parent or legal guardian's 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.
Any current use of ocular topical medication.
Any previous or planned ocular or intraocular surgery, including refractive surgery.

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Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Participation in any prior myopia control clinical study in the test group.
Current or recent (within 30 days from enrollment) rigid lens wearers.
History of orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal contact or spectacle lenses) or drugs (e.g., atropine or pirenzepine) for the purpose of controlling myopia progression.
Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved equivalent) Rewetting Drop Solution.
Relatives of employee of investigational clinic (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, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.
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.
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai EENT Hospital
Shanghai, 200031

Other trials in China

About this study

This is a multi-site, prospective, randomized, controlled, double-masked, four-arm-parallel-group, dispensing study. Each subject will be bilaterally fitted with one of four types of test articles and wear contact lenses of the assigned lens type during the entire course of the study. Test articles will be worn a minimum 8 hours per day and 5 days per week (subjects will be encouraged to wear study contact lenses 10 hours or more per day and 7 days per week) in a daily disposable modality for a minimum of 6 months and up to 1 year for a total of 7 scheduled visits.

Conditions: Visual Acuity
Being tested: EMO-114, EMO-116, EMO-118, EMO-117

What participants receive

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

EMO-114Device
Also called Test Lens 1
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
EMO-116Device
Also called Test Lens 2
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
EMO-118Device
Also called Test Lens 3
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.
EMO-117Device
Also called Test Lens 4
Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Study groups in NCT03408444
Study group	Role	What they receive
EMO-114	Experimental	Test Lens 1 Receives: Device: EMO-114
EMO-116	Experimental	Test Lens 2 Receives: Device: EMO-116
EMO-118	Experimental	Test Lens 3 Receives: Device: EMO-118
EMO-117	Active comparator	Test Lens 4 Receives: Device: EMO-117

What is being measured

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

Axial Length
Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique.
Measured: 6-month follow-up
Spherical Equivalent of Cycloplegic Autorefraction (SECAR)
SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor.
Measured: 6-month follow-up

Timeline

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

27 Dec 201725 May 2019

First posted24 Jan 2018
Study start27 Dec 2017
Primary completion25 May 2019
Study completion25 May 2019

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03408444
Sponsor's protocol ID: CR-5959
Status last verified: May 2022
First submitted: 17 Jan 2018
Last updated: 8 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
Exploration Strategies in Night Vision Sensors
Visual Acuity

All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Soft Contact Lens Prototypes for Myopia Control
ClinicalTrials.gov ID: NCT03408444
Acronym / sponsor ID: CR-5959
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 27 Dec 2017 (actual)
Primary completion: 25 May 2019 (actual)
Study completion: 25 May 2019 (actual)
First posted: 24 Jan 2018 (actual)
Results: Posted 8 Jun 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
EMO-114	Experimental	Device: EMO-114Test Lens 1
EMO-116	Experimental	Device: EMO-116Test Lens 2
EMO-118	Experimental	Device: EMO-118Test Lens 3
EMO-117	Active comparator	Device: EMO-117Test Lens 4

Who may qualify

Ages: 7 to 12 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 (18 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
EMO-114Also: Test Lens 1Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.	Device	EMO-114
EMO-116Also: Test Lens 2Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.	Device	EMO-116
EMO-118Also: Test Lens 3Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.	Device	EMO-118
EMO-117Also: Test Lens 4Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.	Device	EMO-117

Primary outcome

Axial Length
Time frame: 6-month follow-up
Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique.
Spherical Equivalent of Cycloplegic Autorefraction (SECAR)
Time frame: 6-month follow-up
SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor.

Results and safety

Results posted to the registry on 8 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test 1	50	49
Test 2	48	45
Test 3	50	44
Control	51	47

Primary outcome: Axial Length

Time frame: 6-month follow-up. Mean (Standard Deviation). Unit: mm

Measure	Test 1 n = 47	Test 2 n = 46	Test 3 n = 44	Control n = 47
Value	0.119 (0.1008)	0.135 (0.1165)	0.079 (0.1251)	0.189 (0.1206)

Test 1 vs Control: Mean Difference: -0.063 (95% CI -0.106 to -0.020), Mixed Models Analysis
Test 2 vs Control: Mean Difference: -0.056 (95% CI -0.100 to -0.013), Mixed Models Analysis
Test 3 vs Control: Mean Difference: -0.105 (95% CI -0.149 to -0.062), Mixed Models Analysis

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.

Primary outcome: Spherical Equivalent of Cycloplegic Autorefraction (SECAR)

Time frame: 6-month follow-up. Mean (Standard Deviation). Unit: D

Measure	Test 1 n = 47	Test 2 n = 46	Test 3 n = 44	Control n = 47
Value	-0.26 (0.32)	-0.25 (0.35)	-0.12 (0.27)	-0.35 (0.33)

Test 1 vs Control: Mean Difference: 0.08 (95% CI -0.04 to 0.21), Mixed Models Analysis
Test 2 vs Control: Mean Difference: 0.12 (95% CI -0.01 to 0.25), Mixed Models Analysis
Test 3 vs Control: Mean Difference: 0.22 (95% CI 0.09 to 0.35), Mixed Models Analysis

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.

Adverse events

Time frame: Throughout the duration of the study, 6-month up to 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1	0 of 50 (0%)	9 of 50 (18%)	0 of 50
Test 2	1 of 48 (2.1%)	4 of 48 (8.3%)	0 of 48
Test 3	1 of 50 (2%)	2 of 50 (4%)	0 of 50
Control	0 of 51 (0%)	1 of 51 (2%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Visual Acuity

Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
Exploration Strategies in Night Vision Sensors
Visual Acuity

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 EMO-114, EMO-116 and EMO-118 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 18 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 8 Jun 2022. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2022). 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?

Axial Length (time frame: 6-month follow-up). The study lists 2 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 NCT03408444.

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 8 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.