MyopiaNCT01829191

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

A study testing Soft Contact Test Lens A and Soft Contact Test Lens C in people with Myopia, 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

Search all trials

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 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Soft Contact Test Lens A and Soft Contact Test Lens C
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2008to 1 May 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
Healthy volunteers accepted
Child

Who may be able to join

The subject must be between 8 and 12 years of age.
At least one of the subject's parents or legal guardian must read and understand English or Chinese.
The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: <1.50D in each eye.
The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: < or equal to 1.00D in each eye.
The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction.

Show all 9Show fewer

The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes.
The subject's parent or legal guardian must read and sign the STAEMENT 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 this 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 medications (e.g. antihistamine), which may 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.
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 by cycloplegic refraction.
Astigmatism of greater than 1.00D in either eye by cycloplegic refraction.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks.
Strabismus in either eye.
Pupil or 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.
An anterior chamber angle grade 2 or narrower by the Van Herrick method

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Controlling Myopia Progression With Soft Contact Lenses

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

Conditions: Myopia
Being tested: Soft Contact Test Lens A, Soft Contact Test Lens C
Medical subject headings: Myopia

What participants receive

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

Soft Contact Test Lens ADevice
FDA-approved, non-marketed daily disposable soft contact lens, conventional design
Soft Contact Test Lens CDevice
Daily disposable soft contact lens with new optical design

Study groups in NCT01829191
Study group	Role	What they receive
Test Lens A	Experimental	Test lenses will be worn in a daily wear modality Receives: Device: Soft Contact Test Lens A
Test Lens C	Experimental	Test lenses will be worn in a daily wear modality Receives: Device: Soft Contact Test Lens C

What is being measured

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

Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.
Measured: Baseline and every 6 months post-baseline for 2 years

Secondary outcomes (1)

Axial Length
Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.
Measured: Baseline and every 6 months 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 20081 May 2010

First posted11 Apr 2013 (estimated)
Study start1 Apr 2008
Primary completion1 May 2010
Study completion1 May 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.
Publications (2)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01829191
Sponsor's protocol ID: CR-1561AD
Status last verified: Apr 2018
First submitted: 8 Apr 2013
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645
Cheng X, Xu J, Brennan NA. Accommodation and its role in myopia progression and control with soft contact lenses. Ophthalmic Physiol Opt. 2019 May;39(3):162-171. doi: 10.1111/opo.12614.
PubMed 30994197

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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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: NCT01829191
Acronym / sponsor ID: CR-1561AD
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2008 (actual)
Primary completion: 1 May 2010 (actual)
Study completion: 1 May 2010 (actual)
First posted: 11 Apr 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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Test Lens A	Experimental	Device: Soft Contact Test Lens ATest lenses will be worn in a daily wear modality
Test Lens C	Experimental	Device: Soft Contact Test Lens CTest lenses will be worn in a daily wear modality

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (9 listed)

The subject must be between 8 and 12 years of age.
At least one of the subject's parents or legal guardian must read and understand English or Chinese.
The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: <1.50D in each eye.
The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: < or equal to 1.00D in each eye.

Key exclusion criteria (20 listed)

Ocular or systemic allergies or diseases that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medications (e.g. antihistamine), which may 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.
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
Soft Contact Test Lens AFDA-approved, non-marketed daily disposable soft contact lens, conventional design	Device	Test Lens A
Soft Contact Test Lens CDaily disposable soft contact lens with new optical design	Device	Test Lens C

Primary outcome

Spherical Equivalent Refractive Error
Time frame: Baseline and every 6 months post-baseline for 2 years
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.

1 secondary outcome

Axial Length
Time frame: Baseline and every 6 months for 2 years

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 A	63	56
Test Lens C	64	50

Primary outcome: Spherical Equivalent Refractive Error

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

Measure	Test Lens A n = 59	Test Lens C n = 53
Change from baseline 6 months	-0.386 (0.3270)	-0.185 (0.2873)
Change from baseline 12 months	-0.679 (0.5253)	-0.548 (0.4050)
Change from baseline 18 months	-0.934 (0.4761)	-0.614 (0.4140)
Change from baseline 24 months	-1.054 (0.4559)	-1.080 (0.6800)

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 132 (0%)	0 of 132 (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.
Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
Derived from this study: PubMed 30994197Cheng X, Xu J, Brennan NA. Accommodation and its role in myopia progression and control with soft contact lenses. Ophthalmic Physiol Opt. 2019 May;39(3):162-171. doi: 10.1111/opo.12614.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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 Soft Contact Test Lens A and Soft Contact Test Lens C in people with Myopia, 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 9 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 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 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 Refractive Error (time frame: Baseline and every 6 months post-baseline for 2 years). 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 NCT01829191, which also lists 2 linked publications.

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.