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RecruitingNCT07566234Updated Jul 16, 2026

Evaluation of Contact Lenses and Myopia.

An interventional study of Test Lens - Dual Focus in Pre-myopia, sponsored by CooperVision International Limited (CVIL). Recruiting at 1 site in China. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by CooperVision International Limited (CVIL) (part of CooperCompanies) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
8 Years to 10 Years
Sex
All
01

Study summary

This study will evaluate the effect of dual focus contact lenses on Myopia prevention.

02

Conditions studied

  • Pre-myopia

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 110 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 6 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 66 (89%) have results posted.

Browse CooperVision International Limited (CVIL) studies →All CooperCompanies studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female children aged between 8-10 years inclusive.
  2. Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
  3. Astigmatism ≤ -1.00D in both eyes.
  4. Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
  5. 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.
  6. 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.
  7. 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.
  8. 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.)
  9. Be in good general health, based on his/her and parent's/guardian's knowledge.
  10. Any history of myopia control interventions with in 1 month must complete a 4-weeks of .

Exclusion criteria

Exclusion Criteria:

  1. History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
  2. Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
  3. Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
  4. Ocular or systemic disease that contraindicates contact lens wear.
  5. Active allergic conjunctivitis.
  6. Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
  7. Keratoconus or an irregular cornea.
  8. History of binocular vision abnormality or strabismus.
  9. Any active anterior segment finding that would contraindicate contact lens wear.
  10. The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Test Lens

    Device: Test Lens - Dual Focus

Interventions

  • DeviceTest Lens - Dual Focus

    Dual-Focus Contact Lens

06

What researchers measure

Primary outcomes

  1. Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years.

    Time frame: Through study completion, 2 years.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07566234
Lead sponsor
CooperVision International Limited (CVIL)
Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jun 6, 2026
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Jul 16, 2026

Study contacts

Baskar Arumugam Sr. Research Lead, PhD
Contact
barumugam@coopervision.com
925-353-8468
Xiangui He, PhD
principal investigator · Shanghai Eye Disease Prevention and Treatment Center
Mengjun Zhu
principal investigator · Shanghai Eye Disease Prevention and Treatment Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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