MyopiaNCT00762970

Controlling Myopia Progression With Soft Contact Lenses

A study testing Test Lens 1 and Test Lens 2 in people with Myopia, 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

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 Lens 1 and Test Lens 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: 1 Apr 2007to 1 Feb 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

Myopic subjects between 8 and 12 years of age.
The subject 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
1.00D or less difference in spherical equivalent between the two eyes
The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes
The subject must have at least 8D of accommodation
The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Who cannot join

Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Show all 20Show fewer

Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
Diabetes
Anisometropia of greater than 1.00D
Astigmatism of greater than 1.00D in either eye
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye.
Strabismus in either eye
Pupil orr lid abnormality or infection in either eye
Central corneal scar in either eye
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 prior 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.

China1 site

The Tianjin Eye Hospital
Tianjin, 300020

Other trials in China

About this study

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

Read the detailed description

The study will be a prospective, randomized, single blind, bilateral dispensing study

Conditions: Myopia
Being tested: Test Lens 1, Test Lens 2, Control Lens
Medical subject headings: Myopia

What participants receive

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

Test Lens 1Device
Investigational soft contact lens with asperic optical design to control myopia progression.
Test Lens 2Device
Investigational soft contact lens with asperic optical design to control myopia progression.
Control LensDevice
Spectacle Lenses.

Study groups in NCT00762970
Study group	Role	What they receive
Test Lens 1	Experimental	Investigational soft contact lenses worn daily. Receives: Device: Test Lens 1
Test Lens 2	Experimental	Investigational soft contact lenses worn daily. Receives: Device: Test Lens 2
Control lens	Active comparator	Spectacle lenses worn daily. Receives: Device: Control Lens

What is being measured

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

Spherical Equivalent Refraction
Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.
Measured: Baseline and every 6 months post-baseline for 2 years
Axial Length (Axial Elongation)
Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.
Measured: Baseline and every 6 months post-baseline for 2 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 Feb 2010

First posted30 Sep 2008 (estimated)
Study start1 Apr 2007
Primary completion1 Feb 2010
Study completion1 Feb 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: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762970
Sponsor's protocol ID: CR-1561AB
Status last verified: Apr 2018
First submitted: 26 Sep 2008
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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: NCT00762970
Acronym / sponsor ID: CR-1561AB
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2007 (actual)
Primary completion: 1 Feb 2010 (actual)
Study completion: 1 Feb 2010 (actual)
First posted: 30 Sep 2008 (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.

Detailed description

The study will be a prospective, randomized, single blind, bilateral dispensing study

Study design

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

Arm	Type	Receives
Test Lens 1	Experimental	Device: Test Lens 1Investigational soft contact lenses worn daily.
Test Lens 2	Experimental	Device: Test Lens 2Investigational soft contact lenses worn daily.
Control lens	Active comparator	Device: Control LensSpectacle 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)

Myopic subjects between 8 and 12 years of age.
The subject 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
1.00D or less difference in spherical equivalent between the two eyes
The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes

Key exclusion criteria (20 listed)

Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with 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 Lens 1Investigational soft contact lens with asperic optical design to control myopia progression.	Device	Test Lens 1
Test Lens 2Investigational soft contact lens with asperic optical design to control myopia progression.	Device	Test Lens 2
Control LensSpectacle Lenses.	Device	Control lens

Primary outcome

Spherical Equivalent Refraction
Time frame: Baseline and every 6 months post-baseline for 2 years
Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.
Axial Length (Axial Elongation)
Time frame: Baseline and every 6 months post-baseline for 2 years
Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.

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 Lens 1	46	34
Test Lens 2	44	35
Control Lens	47	46

Primary outcome: Spherical Equivalent Refraction

Time frame: Baseline and every 6 months post-baseline for 2 years. Mean (Standard Deviation). Unit: diopter (D)

Measure	Test Lens 1 n = 35	Test Lens 2 n = 37	Control Lens n = 46
Change from baseline 6 months	-0.326 (0.6678)	-0.460 (0.3938)	-0.430 (0.3942)
Change from baseline 12 months	-0.898 (0.4695)	-0.859 (0.4955)	-0.905 (0.5918)
Change from baseline 18 months	-1.222 (0.8501)	-1.185 (0.6550)	-1.336 (0.7361)
Change from baseline 24 months	-1.506 (0.9346)	-1.376 (0.5891)	-1.809 (0.9485)

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

Primary outcome: Axial Length (Axial Elongation)

Time frame: Baseline and every 6 months post-baseline for 2 years. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Test Lens 1 n = 35	Test Lens 2 n = 37	Control Lens n = 46
Change from baseline 6 months	0.214 (0.1020)	0.198 (0.1128)	0.263 (0.1766)
Change from baseline 12 months	0.401 (0.1816)	0.382 (0.1974)	0.458 (0.2323)
Change from baseline 18 months	0.564 (0.2371)	0.522 (0.2643)	0.622 (0.2805)
Change from baseline 24 months	0.660 (0.2355)	0.529 (0.2378)	0.749 (0.3203)

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
Test Lens 1	0 of 46 (0%)	0 of 46 (0%)	Not reported
Test Lens 2	0 of 44 (0%)	0 of 44 (0%)	Not reported
Control Lens	0 of 47 (0%)	0 of 47 (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
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
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RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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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.

Xu Cheng, MD, PhD principal investigator

Principal Clinical Scientist

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 Lens 1 and Test Lens 2 in people with Myopia, 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 8 inclusion and 20 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 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 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?

Spherical Equivalent Refraction (time frame: Baseline and every 6 months post-baseline for 2 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 NCT00762970.

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.