NCT07566234 Evaluation of Contact Lenses and Myopia.
| NCT ID | NCT07566234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CooperVision International Limited (CVIL) |
| Condition | Pre-myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-06-06 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2026-06-06 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
Eligibility Criteria
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.
Contact & Investigator
Xiangui He, PhD
PRINCIPAL INVESTIGATOR
Shanghai Eye Disease Prevention and Treatment Center
Frequently Asked Questions
Who can join the NCT07566234 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 10 Years, studying Pre-myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566234 currently recruiting?
Yes, NCT07566234 is actively recruiting participants. Contact the research team at barumugam@coopervision.com for enrollment information.
Where is the NCT07566234 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07566234 clinical trial?
NCT07566234 is sponsored by CooperVision International Limited (CVIL). The principal investigator is Xiangui He, PhD at Shanghai Eye Disease Prevention and Treatment Center. The trial plans to enroll 110 participants.