MyopiaNCT01787760

Controlling Myopia Progression With Soft Contact Lenses

A study testing Test Soft Contact Lens B, Test Soft Contact Lens C and Active Comparator in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

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 study is to investigate whether novel soft contact lens optical designs can slow myopia progression. Read more about this study

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Myopia
What is being tested?: Test Soft Contact Lens B, Test Soft Contact Lens C and Active Comparator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 221 participants
Where: 1 siteHong Kong
Study dates: 1 Apr 2007to 1 Apr 2010
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 8 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

The subject must be between 8 and 12 years of age and of Asia origin.
The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
Astigmatism must be less than or equal to 1.00D
Less than 1.00D difference in spherical equivalent between the two eyes
The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
The subject must have at least 8D of accommodation.
The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form
The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol

Who cannot join

Ocular or systemic allergies or diseases that may interfere with contact lens wear
Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Show all 19Show fewer

Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
Diabetes.
Anismetropia.
Astigmatism of greater than 1.00D in either eye.
Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
Strabismus in either eye
Pupil or lid abnormality or infection in either eye
Central corneal scar and aphakia in either eye
Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear
History of participation in clinical trials aimed to control myopia progression
Surgically altered eyes, ocular infection of any type, ocular inflammation
Subject has anterior chamber angle grade 2 or narrower

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Hong Kong Polytechnic University
Hung Hom, Kowloon

Other trials in Hong Kong

About this study

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Conditions: Myopia
Being tested: Test Soft Contact Lens B, Test Soft Contact Lens C, Active Comparator
Medical subject headings: Myopia

What participants receive

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

Test Soft Contact Lens BDevice
Test lenses to be worn in daily wear modality
Test Soft Contact Lens CDevice
Test lenses to be worn in a daily wear modality
Active ComparatorDevice
Control spectacle lenses to be worn in a daily wear modality

Study groups in NCT01787760
Study group	Role	What they receive
Test Soft Contact Lens B	Experimental	Lenses will be worn in a daily disposable modality Receives: Device: Test Soft Contact Lens B
Test Soft Contact Lens C	Experimental	Lenses will be worn in a daily disposable modality Receives: Device: Test Soft Contact Lens C
Spectacle Lenses	Active comparator	Control spectacle lenses worn daily. Receives: Device: Active Comparator

What is being measured

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

Axial Length (Axial Elongation)
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Measured: Baseline and every 6 months post-baseline up to 3 years
Spherical Equivalent Refraction
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.
Measured: Baseline and every 6 months post-baseline up to 3 years

Timeline

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

1 Apr 20071 Apr 2010

First posted11 Feb 2013 (estimated)
Study start1 Apr 2007
Primary completion1 Apr 2010
Study completion1 Apr 2010

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 MyopiaStudies 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
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01787760
Sponsor's protocol ID: CR-1561AC
Status last verified: Apr 2018
First submitted: 6 Feb 2013
Last updated: 19 Jun 2018
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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlling Myopia Progression With Soft Contact Lenses
ClinicalTrials.gov ID: NCT01787760
Acronym / sponsor ID: CR-1561AC
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2007 (actual)
Primary completion: 1 Apr 2010 (actual)
Study completion: 1 Apr 2010 (actual)
First posted: 11 Feb 2013 (estimated)
Results: Posted 29 Jul 2015

Clinical summary

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

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Test Soft Contact Lens B	Experimental	Device: Test Soft Contact Lens BLenses will be worn in a daily disposable modality
Test Soft Contact Lens C	Experimental	Device: Test Soft Contact Lens CLenses will be worn in a daily disposable modality
Spectacle Lenses	Active comparator	Device: Active ComparatorControl spectacle lenses worn daily.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

The subject must be between 8 and 12 years of age and of Asia origin.
The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
Astigmatism must be less than or equal to 1.00D
Less than 1.00D difference in spherical equivalent between the two eyes
The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes

Key exclusion criteria (19 listed)

Ocular or systemic allergies or diseases that may interfere with contact lens wear
Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
Any ocular infection.

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
Test Soft Contact Lens BTest lenses to be worn in daily wear modality	Device	Test Soft Contact Lens B
Test Soft Contact Lens CTest lenses to be worn in a daily wear modality	Device	Test Soft Contact Lens C
Active ComparatorControl spectacle lenses to be worn in a daily wear modality	Device	Spectacle Lenses

Primary outcome

Axial Length (Axial Elongation)
Time frame: Baseline and every 6 months post-baseline up to 3 years
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Spherical Equivalent Refraction
Time frame: Baseline and every 6 months post-baseline up to 3 years
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.

Results and safety

Results posted to the registry on 29 Jul 2015, 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 Soft Contact Lens B	51	25
Test Soft Contact Lens C	50	34
Spectacle Lenses	51	46

Primary outcome: Axial Length (Axial Elongation)

Time frame: Baseline and every 6 months post-baseline up to 3 years. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Spectacle Lenses n = 48	Test Soft Contact Lens B n = 36	Test Soft Contact Lens C n = 37
Change from baseline 6 months	0.158 (0.0981)	0.144 (0.0834)	0.121 (0.0749)
Change from baseline 12 months	0.242 (0.1448)	0.236 (0.1267)	0.222 (0.1288)
Change from baseline 18 months; N=92, N=54, N=72	0.348 (0.2129)	0.355 (0.1837)	0.344 (0.1676)
Change from baseline 24 months; N=92, N=54, N=72	0.455 (0.2520)	0.409 (0.2247)	0.445 (0.2444)
Change from baseline 30 months	0.565 (0.2941)	0.512 (0.2634)	0.511 (0.2564)
Change from baseline 36 months	0.640 (0.3199)	0.634 (0.3249)	0.512 (0.3072)

Population analysed: Analysis was conducted on all randomized subjects who have at least one data point.

Primary outcome: Spherical Equivalent Refraction

Time frame: Baseline and every 6 months post-baseline up to 3 years. Mean (Standard Deviation). Unit: diopter (D)

Measure	Spectacle Lenses n = 48	Test Soft Contact Lens B n = 36	Test Soft Contact Lens C n = 37
Change from baseline 6 months	-0.238 (0.3443)	-0.327 (0.3038)	-0.230 (0.3436)
Change from baseline 12 months	-0.417 (0.4557)	-0.456 (0.3733)	-0.429 (0.4199)
Change from baseline 18 months	-0.562 (0.5841)	-0.692 (0.3965)	-0.720 (0.4988)
Change from baseline 24 months	-0.776 (0.6185)	-0.781 (0.4447)	-0.861 (0.5504)
Change from baseline 30 months	-0.966 (0.7592)	-1.000 (0.5485)	-1.003 (0.6829)
Change from baseline 36 months	-1.073 (0.9922)	-1.266 (0.3193)	-0.824 (0.8244)

Population analysed: Analysis was conducted on all randomized subjects who have at least one data point.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spectacle Lenses	0 of 51 (0%)	0 of 51 (0%)	Not reported
Test Soft Contact Lens B	0 of 51 (0%)	7 of 51 (13.7%)	Not reported
Test Soft Contact Lens C	0 of 50 (0%)	4 of 50 (8%)	Not reported
Not Randomized	0 of 13 (0%)	0 of 13 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruitingPhase 4
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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 Test Soft Contact Lens B, Test Soft Contact Lens C and Active Comparator in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

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 8 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 19 Jun 2018. 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 Hong Kong. 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 29 Jul 2015). 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 (Axial Elongation) (time frame: Baseline and every 6 months post-baseline up to 3 years). 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 NCT01787760.

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 19 Jun 2018.