MyopiaNCT07845721
Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
A study testing Test Spectacle Lens & Contact Lens in people with Myopia, run by CooperVision International Limited (CVIL) at 2 sites in 2 countries.
Trial summary
Effect of alternating contact lenses and spectacles for myopia control. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- Test Spectacle Lens & Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Are aged 11 to 17 years (inclusive);
- Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study;
- Are established soft contact lens wearers (including myopia control contact lens designs);
- Have read and signed the study consent or assent form, as appropriate for their age;
- Have a parent or legal guardian who has read and signed the Parent/Guardian Information Sheet (PIS) and Consent Form;
- Are willing and able to follow study instructions and maintain the appointment schedule;
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- Are willing to wear the study contact lenses for 10 hours/day and 5 days per week as an ideal target while participating;
- Require a spherical contact lens power correction between -0.50 and -6.00 D;
- Have astigmatism not exceeding 2.00 DC in each eye by subjective refraction;
- Have best-corrected visual acuity of 0.10 logMAR (approx. 20/25 Snellen) or better in each eye;
- Have ocular health findings (biomicroscopy) that do not contraindicate contact lens wear;
- Continue to demonstrate acceptable fit and handling with the study contact lenses.
Who cannot join
- Are participating in any concurrent clinical or interventional study;
- Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days;
- Have used atropine concentrations above 0.01% for myopia control in the previous 30 days;
- Are extended-wear contact lens users (i.e., sleep in their lenses);
- Have best-corrected visual acuity worse than 0.10 logMAR in either eye;
- Have any current or evolving ocular or systemic condition that could affect visual function, ocular growth, or contact lens wear;
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- Have any clinically significant corneal or conjunctival staining with sodium fluorescein, or other ocular findings contraindicating contact lens wear;
- Are using systemic or topical medications known or expected to affect pupil size, tear production, accommodation, refractive state, or any study outcome variable;
- Have a history of ocular surgery, keratoconus, or other forms of irregular cornea, or are aphakic;
- Have diagnosed accommodative and/or binocular vision anomalies, including amblyopia, strabismus, or nystagmus;
- Have known sensitivity or allergy to any of the diagnostic agents used in the study;
- Have any systemic condition that, in the opinion of the investigator, may influence study outcomes or contraindicate soft contact lens wear, including pregnancy;
- Are a child of an employee of either clinical site directly involved in the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site
Centre for Ocular Research & Education (CORE) School of Optometry & Vision Science University of Waterloo
Waterloo, Ontario, N2L 3Gi
Jill Woods, 1-519 888 4567 ext 436743, jwoods@uwaterloo.ca
Jill Woods
United Kingdom1 site
Aston University
Birmingham, B4 7ET
Nicola Logan, 0121 204 4128, n.s.logan@aston.ac.uk
Nicola Logan
About this study
Official title: Twelve-Month Outcomes in Children Using MiSight® 1-Day Contact Lenses and Myopia Control Spectacle Lenses as Complementary Myopia Control Interventions.
Effect of alternating contact lenses and spectacles for myopia control.
- Conditions
- Myopia
- Being tested
- Test Spectacle Lens & Contact Lens, Control Spectacle Lens & Contact 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 Spectacle Lens & Contact LensDevice
Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and test spectacle lenses for remaining waking hours.
Control Spectacle Lens & Contact LensDevice
Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and control spectacle lenses for remaining waking hours.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Participants will wear Test Spectacle Lens \& Contact Lenses Receives: Device: Test Spectacle Lens & Contact Lens |
| Control Group | Experimental | Participants will wear Control Spectacle Lens \& Contact Lenses Receives: Device: Control Spectacle Lens & Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length (AXL, mm) over 12 months
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SightGlass Vision, Inc.
- Responsible party
- Sponsor
- Investigators
- Baskar Arumugam, PhD, Study chair, CooperVision, Inc.Debbbie Laughton, Study chair, SightGlass Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845721
- Sponsor's protocol ID
- CV-25-34
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-Month Outcomes in Children Using MiSight® 1-Day Contact Lenses and Myopia Control Spectacle Lenses as Complementary Myopia Control Interventions.
- ClinicalTrials.gov ID
- NCT07845721
- Acronym / sponsor ID
- CV-25-34
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- SightGlass Vision, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of alternating contact lenses and spectacles for myopia control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Test Spectacle Lens & Contact LensParticipants will wear Test Spectacle Lens \& Contact Lenses |
| Control Group | Experimental | Device: Control Spectacle Lens & Contact LensParticipants will wear Control Spectacle Lens \& Contact Lenses |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Are aged 11 to 17 years (inclusive);
- Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study;
- Are established soft contact lens wearers (including myopia control contact lens designs);
- Have read and signed the study consent or assent form, as appropriate for their age;
- Have a parent or legal guardian who has read and signed the Parent/Guardian Information Sheet (PIS) and Consent Form;
Key exclusion criteria (13 listed)
- Are participating in any concurrent clinical or interventional study;
- Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days;
- Have used atropine concentrations above 0.01% for myopia control in the previous 30 days;
- Are extended-wear contact lens users (i.e., sleep in their lenses);
- Have best-corrected visual acuity worse than 0.10 logMAR in either eye;
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 Spectacle Lens & Contact LensParticipants will wear contact lenses for a target of 10 hours a day, 5 days per week and test spectacle lenses for remaining waking hours. | Device | Test Group |
| Control Spectacle Lens & Contact LensParticipants will wear contact lenses for a target of 10 hours a day, 5 days per week and control spectacle lenses for remaining waking hours. | Device | Control Group |
Primary outcome
Change in axial length (AXL, mm) over 12 months
Time frame: Over 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
Baskar Arumugam, PhD study chair
CooperVision, Inc.
Debbbie Laughton study chair
SightGlass Vision, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Spectacle Lens & Contact Lens in people with Myopia, run by CooperVision International Limited (CVIL) at 2 sites in 2 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 12 inclusion and 13 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baskar Arumugam, PhD (1(925) 353-8468, barumugam@coopervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length (AXL, mm) over 12 months (time frame: Over 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.