Evaluation of Contact Lenses and Myopia.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-myopia
• Intervention / Treatment: Device: Test Lens - Dual Focus

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baskar Arumugam Sr. Research Lead, PhD; Phone Number: 925-353-8468; Email: barumugam@coopervision.com

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 washout period.

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 clinically significant 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Lens	Device: Test Lens - Dual Focus; Dual-Focus Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years.	Through study completion, 2 years.

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Principal Investigator: Xiangui He, PhD, Shanghai Eye Disease Prevention and Treatment Center; Principal Investigator: Mengjun Zhu, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CV-25-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes