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
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.
Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D.
Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
Single group
Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
DeviceBausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
DeviceCooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens
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.
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.
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