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

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorBausch & Lomb Incorporated

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic)
  • CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens

Treatment groups

418 Participants
are divided into 2 treatment groups

Sponsors and collaborators