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

Last updated: May 22, 2024
Sponsor: Bausch & Lomb Incorporated
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Eye Disorders/infections

Treatment

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

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

Clinical Study ID

NCT06305663
921
  • Ages 8-12
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assentand Parental or Guardian Informed Consent are signed and have capacity to providevoluntary informed consent.

  2. Subject must meet the following determined by cycloplegic subjective refraction inboth eyes at screening:

  3. Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D,inclusive.

  4. Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D.

  5. Subject must be myopic and require lens correction from -0.75 D to -4.00 D, atscreening, in each eye.

  6. Subject must have distance best-spectacle corrected visual acuity (BSCVA) bynon-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) orbetter in each eye.

  7. Subject and Parent or Guardian must be willing to participate in either the test orthe comparator assignment.

  8. Subject agrees to wear the assigned contact lenses for a minimum of 10 hours perday, at least 6 days per week, for the duration of the 24-month study.

  9. Subject must have wearable and visually functioning eyeglasses.

  10. Subject must be in good general health according to their and parent's or guardian'sknowledge

Exclusion

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 softcontact lenses, atropine, pirenzepine or ANY other myopia control treatment.

  3. Subject appears to exhibit poor personal hygiene (that in the Investigator's opinionmight prevent safe contact lens wear).

  4. Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeksor 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 wearingof corneal contact lenses, pupil size, adjustment or refractive status, or requirethe 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 ocularinfections.

  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 oriritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupuserythematosus, scleroderma, or diabetes.

  11. At the discretion of the Investigator, any ocular, systemic or neuro developmentalconditions 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-Danlossyndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjectswith trichiasis, that in the Investigator's judgement does not interfere withcontact 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, orsubjects 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. Subjectswith 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, areeligible for this study.

  15. The Investigator for any reason considers that it is not in the best interest of theSubject to participate in the study.

  16. Subjects participating in any drug clinical investigation within 4 weeks or deviceclinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of studyparticipation.

  17. Immediate family or close relative is a member of site study team members

Study Design

Total Participants: 418
Treatment Group(s): 2
Primary Treatment: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
Phase:
Study Start date:
March 29, 2024
Estimated Completion Date:
January 31, 2027

Study 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

Connect with a study center

  • Site 105

    Beijing, Beijing 100044
    China

    Site Not Available

  • Site 107

    Dongcheng, Beijing 100730
    China

    Site Not Available

  • Site 109

    Xiamen, Fujian 361004
    China

    Site Not Available

  • Site 111

    Haikou, Hainan 570311
    China

    Site Not Available

  • Site 110

    Wuhan, Hubei 430012
    China

    Site Not Available

  • Site 102

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Site 106

    Taiyuan, Shanxi 030072
    China

    Site Not Available

  • Site 108

    Shenzhen, Shenzhen 518040
    China

    Site Not Available

  • Site 103

    Chengdu, Sichaun Province 610044
    China

    Site Not Available

  • Site 104

    Nankai, Tianjin 300392
    China

    Site Not Available

  • Site 101

    Wenzhou, Zhejiang 325027
    China

    Active - Recruiting

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