Clinical trial Recruiting at 1 site Interventional Ages 8 to 12

Evaluating Myopia Control Lenses for Children

Official title: A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children

Run by Bausch & Lomb Incorporated · NCT06305663 · Data updated 2026-11-12

This study is testing if Bausch + Lomb Myopia Control Lenses can help children aged 8 to 12 with nearsightedness see better and slow down their vision worsening compared to another type of lens.

Quick facts

Study typeInterventional
Ages8 Years to 12 Years
SexAll
Enrollment418 (estimated)
SponsorBausch & Lomb Incorporated
Industry-sponsored
Locations11 sites (Beijing, Beijing Municipality and 10 other locations)
StatusRecruiting
StartedMarch 29, 2024
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2027
Registry record updatedJune 15, 2025
Trial IDNCT06305663 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 8 to 12 years with myopia requiring lens correction between -0.75 D and -4.00 D.

Probably not a fit

Patients with severe myopia outside the specified range or those with significant astigmatism may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of Bausch + Lomb Myopia Control Lenses in children aged 8 to 12 years to correct myopic ametropia and slow the progression of myopia. It is a multi-center, randomized, parallel, bilateral, investigator-masked study that compares these lenses to a control group using CooperVision MiSight lenses. Participants will wear the assigned lenses for a minimum of 10 hours per day, at least 6 days a week, to assess their impact on myopia progression.

Why it matters

Potential benefit: If successful, this study could provide a new effective method for controlling myopia progression in children.

How similar studies have gone: Other studies have shown promise in using contact lenses for myopia control, indicating that this approach is supported by prior research.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent.
2. Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:

   1. Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
   2. Astigmatism: ≤ -0.75 D. c. Anisometropia: \< 1.00 D.
3. Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
4. Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye.
5. Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
6. Subject agrees to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 24-month study.
7. Subject must have wearable and visually functioning eyeglasses.
8. Subject must be in good general health according to their and parent's or guardian's knowledge

Exclusion Criteria:

1. Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
2. Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
3. Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
4. Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
5. Prior strabismus, intraocular, or refractive surgery.
6. Subject using any systemic or local eye medication that interfere with the wearing of corneal contact lenses, pupil size, adjustment or refractive status, or require the removal of lenses during the day".
7. A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
9. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
10. Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, or diabetes.
11. At the discretion of the Investigator, any ocular, systemic or neuro developmental conditions that could influence refractive development such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis, eyelid hemangiomas, Marfan's syndrome, Down syndrome, Ehlers-Danlos syndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjects with trichiasis, that in the Investigator's judgement does not interfere with contact lens wear, are eligible for this study.
12. Keratoconus or an irregular cornea.
13. Subjects with any Grade 2 or greater finding during the slit lamp examination, or subjects with any scar or neovascularization within the central 6 mm of the cornea, or subjects with corneal infiltrates, of ANY GRADE.
14. Subjects with any "present" finding during the slit lamp examination (biomicroscopy) that, in the investigator's judgment, interferes with contact lens wear. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment does not interfere with contact lens wear, are eligible for this study.
15. The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study.
16. Subjects participating in any drug clinical investigation within 4 weeks or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of study participation.
17. Immediate family or close relative is a member of site study team members

Where it's running

  • Site 101
    Wenzhou, Zhejiang, China
    Recruiting
  • Site 105
    Beijing, Beijing Municipality, China
    Active not recruiting
  • Site 107
    Dongcheng, Beijing Municipality, China
    Active not recruiting
  • Site 109
    Xiamen, Fujian, China
    Active not recruiting
  • Site 111
    Haikou, Hainan, China
    Active not recruiting
  • Site 110
    Wuhan, Hubei, China
    Active not recruiting
Show 5 more locations
  • Site 102
    Shanghai, Shanghai Municipality, China
    Active not recruiting
  • Site 106
    Taiyuan, Shanxi, China
    Active not recruiting
  • Site 108
    Shenzhen, Shenzhen, China
    Active not recruiting
  • Site 103
    Chengdu, Sichaun Province, China
    Active not recruiting
  • Site 104
    Nankai, Tianjin Municipality, China
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.