MyopiaNCT01729208
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
A study testing Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens in people with Myopia, run by CooperVision, Inc. at 4 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Nov 2012to 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 8 and 12 years of age inclusive.
- Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
- Spherical Equivalent Refractive Error between -0.75 and -4.00 D
- inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
- Possess wearable and visually functional eyeglasses.
- Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.
Who cannot join
- Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
- Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
- Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Canada1 site
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1
Portugal1 site
University of Minho Clinical & Experiment Optometry Research Lab
Braga, 4710-057
Singapore1 site
National University of Singapore Faculty of Medicine
Singapore, 117597
United Kingdom1 site
Aston University Ophthalmic Research Group
Birmingham, B4 7ET
About this study
Official title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Read the detailed description
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
- Conditions
- Myopia
- Being tested
- Dual Focus Soft Contact Lens, Single Vision Soft Contact Lens
- Keywords
- myopia progression, myopia control
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Focus Soft Contact LensDevice
Single Vision Soft Contact LensDevice
| Study group | Role | What they receive |
|---|---|---|
| Dual Focus Soft Contact Lens | Experimental | Dual Focus Soft Contact Lens Receives: Device: Dual Focus Soft Contact Lens |
| Single Vision Soft Contact Lens | Placebo comparator | Single Vision Soft Contact Lens Receives: Device: Single Vision Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Measured: 12 months
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Measured: 24 months
Change in Refractive Error Relative to Baseline
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Measured: 36 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Measured: 12 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Measured: 24 months
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Measured: 36 months
Secondary outcomes (7)
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Measured: Baseline
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Measured: 12 months
Number of Participants With Biomicroscopic Findings
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Measured: 24 months
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Measured: 36 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Measured: 12 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Measured: 24 months
Incidence of Adverse Events
Cumulative incidence of adverse events.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2017
- Study completionMay 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.
- Publications (3)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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- José Manuel González-Méijome, Principal investigator, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729208
- Sponsor's protocol ID
- CVI08008
- Status last verified
- Feb 2020
- First submitted
- 14 Nov 2012
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chamberlain P, Hammond DS, Bradley A, Arumugam B, Richdale K, McNally J, Hunt C, Young G. Eye growth and myopia progression following cessation of myopia control therapy with a dual-focus soft contact lens. Optom Vis Sci. 2025 May 1;102(5):353-358. doi: 10.1097/OPX.0000000000002244. Epub 2025 Mar 24.
PubMed 40132119Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873.
PubMed 35086120Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.
PubMed 31343513
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
- ClinicalTrials.gov ID
- NCT01729208
- Acronym / sponsor ID
- CVI08008
- Conditions
- Myopia
- Keywords
- myopia progression, myopia control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- Nov 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Detailed description
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Focus Soft Contact Lens | Experimental | Device: Dual Focus Soft Contact LensDual Focus Soft Contact Lens |
| Single Vision Soft Contact Lens | Placebo comparator | Device: Single Vision Soft Contact LensSingle Vision Soft Contact Lens |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Be between 8 and 12 years of age inclusive.
- Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
- Spherical Equivalent Refractive Error between -0.75 and -4.00 D
- inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
- Possess wearable and visually functional eyeglasses.
Key exclusion criteria (8 listed)
- Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
- Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
- Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
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 |
|---|---|---|
| Dual Focus Soft Contact Lens | Device | Dual Focus Soft Contact Lens |
| Single Vision Soft Contact Lens | Device | Single Vision Soft Contact Lens |
Primary outcome
Change in Refractive Error Relative to Baseline
Time frame: 12 months
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Change in Refractive Error Relative to Baseline
Time frame: 24 months
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Change in Refractive Error Relative to Baseline
Time frame: 36 months
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Change in Axial Length Relative to Baseline
Time frame: 12 months
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Change in Axial Length Relative to Baseline
Time frame: 24 months
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Change in Axial Length Relative to Baseline
Time frame: 36 months
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
7 secondary outcomes
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Time frame: Baseline
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Time frame: 12 months
Number of Participants With Biomicroscopic Findings
Time frame: 24 months
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Time frame: 36 months
Incidence of Adverse Events
Time frame: 12 months
Incidence of Adverse Events
Time frame: 24 months
Incidence of Adverse Events
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40132119Chamberlain P, Hammond DS, Bradley A, Arumugam B, Richdale K, McNally J, Hunt C, Young G. Eye growth and myopia progression following cessation of myopia control therapy with a dual-focus soft contact lens. Optom Vis Sci. 2025 May 1;102(5):353-358. doi: 10.1097/OPX.0000000000002244. Epub 2025 Mar 24.
- Derived from this study: PubMed 35086120Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873.
- Derived from this study: PubMed 31343513Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.
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.
José Manuel González-Méijome principal investigator
University of Minho
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens in people with Myopia, run by CooperVision, Inc. at 4 sites in 4 countries.
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 6 inclusion and 8 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Portugal, Singapore, United Kingdom. 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. Some participants in this study may receive a placebo. 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 24 Feb 2020). 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?
Change in Refractive Error Relative to Baseline (time frame: 12 months). The study lists 6 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 NCT01729208, which also lists 3 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 24 Feb 2020.