A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Corr… (NCT06305663) | Clinical Trial Compass
RecruitingNot Applicable
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
China418 participantsStarted 2024-03-29
Plain-language 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
Who can participate
Age range8 Years – 12 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
✓. 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 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.
✓. Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
✓. 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.
Exclusion criteria
✕. 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.
✕. Prior strabismus, intraocular, or refractive surgery.
✕. 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".
✕. A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
✕. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.