ClinicalTrials.gg
RecruitingNCT06305663Updated Jun 15, 2025

A 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

An interventional study of Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) and CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens in Myopia, sponsored by Bausch & Lomb Incorporated. Recruiting at 11 sites in China. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
418
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study summary

A 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

Read the detailed description

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

02

Conditions studied

  • Myopia

Browse trials for

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 418 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted after Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

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

04

Who can participate

Ages eligible
8 Years to 12 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 or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian 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

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
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
418 participants (estimated)

Study arms

  • Experimental
    Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)

    Device: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)

  • Active comparator
    CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

    Device: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

Interventions

  • DeviceBausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)

    Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)

  • DeviceCooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

    CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in axial length.

    Mean change from baseline in axial length will be evaluated at the one-year and two-year visits.

    Time frame: 1 and 2 years

  2. Mean change from baseline in cycloplegic SERE.

    Mean change from baseline in cycloplegic SERE will be evaluated at the one-year and two-year visits.

    Time frame: 1 and 2 years

07

Study locations

1 of 11 sites recruiting
  • Site 105
    Beijing, Beijing 100044, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 107
    Dongcheng, Beijing 100730, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 109
    Xiamen, Fujian 361004, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 111
    Haikou, Hainan 570311, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 110
    Wuhan, Hubei 430012, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 102
    Shanghai, Shanghai 200433, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 106
    Taiyuan, Shanxi 030072, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 108
    Shenzhen, Shenzhen 518040, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 103
    Chengdu, Sichaun Province 610044, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 104
    Nankai, Tianjin 300392, China
    Active, not recruiting

    Not enrolling at this site.

  • Site 101
    Wenzhou, Zhejiang 325027, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06305663
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Mar 29, 2024
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jun 15, 2025

Study contacts

Yan Zhang
Contact
Yan.Zhang1@bausch.com
+86 21 60327166

Oversight

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

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