Pre-myopiaNCT07566234
Evaluation of Contact Lenses and Myopia.
A study testing Test Lens - Dual Focus in people with Pre-myopia, run by CooperVision International Limited (CVIL) at 1 site in China.
Trial summary
This study will evaluate the effect of dual focus contact lenses on Myopia prevention. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Pre-myopia
- What is being tested?
- Test Lens - Dual Focus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to May 2029
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children aged between 8-10 years inclusive.
- Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
- Astigmatism ≤ -1.00D in both eyes.
- Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
- As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms.
- Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
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- Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
- Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.
Who cannot join
- History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
- Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- Ocular or systemic disease that contraindicates contact lens wear.
- Active allergic conjunctivitis.
- Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
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- Keratoconus or an irregular cornea.
- History of clinically significant binocular vision abnormality or strabismus.
- Any active anterior segment finding that would contraindicate contact lens wear.
- The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, 200030
About this study
Official title: Myopia Prevention Study in Chinese Population With Dual Focus Myopia Control Lenses.
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
- Conditions
- Pre-myopia
- Being tested
- Test Lens - Dual Focus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Lens - Dual FocusDevice
Dual-Focus Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| Test Lens | Experimental | Not described Receives: Device: Test Lens - Dual Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years.
Measured: Through study completion, 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start6 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center
- Responsible party
- Sponsor
- Investigators
- Xiangui He, PhD, Principal investigator, Shanghai Eye Disease Prevention and Treatment CenterMengjun Zhu, Principal investigator, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566234
- Sponsor's protocol ID
- CV-25-01
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Prevention Study in Chinese Population With Dual Focus Myopia Control Lenses.
- ClinicalTrials.gov ID
- NCT07566234
- Acronym / sponsor ID
- CV-25-01
- Conditions
- Pre-myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Eye Disease Prevention and Treatment Center
- Study start
- 6 Jun 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 5 May 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.
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Lens | Experimental | Device: Test Lens - Dual Focus |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male and female children aged between 8-10 years inclusive.
- Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
- Astigmatism ≤ -1.00D in both eyes.
- Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
- As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms.
Key exclusion criteria (10 listed)
- History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
- Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- Ocular or systemic disease that contraindicates contact lens wear.
- Active allergic conjunctivitis.
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 - Dual FocusDual-Focus Contact Lens | Device | Test Lens |
Primary outcome
Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years.
Time frame: Through study completion, 2 years.
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Xiangui He, PhD principal investigator
Shanghai Eye Disease Prevention and Treatment Center
Mengjun Zhu principal investigator
Shanghai Eye Disease Prevention and Treatment Center
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 - Dual Focus in people with Pre-myopia, run by CooperVision International Limited (CVIL) 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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?
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 Sr. Research Lead, PhD (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?
Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years. (time frame: Through study completion, 2 years.). 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 16 Jul 2026.