Clinical Trials Detalhe

The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Myopia

Inclusion Criteria: * Be between 8 and 12 years of age inclusive. * Best-corrected visual acuity by manifest refraction of +0.10 logMAR. * Spherical Equivalent Refractive Error between -0.75 and -4.00 D * inclusive astigmatism: \< -0.75 D and anisometropia: \< 1.00 D * Possess wearable and visually functional eyeglasses. * Agree 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 3 year study. Exclusion Criteria: * Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses. * Subject is currently or within 30 days prior to this study has been an active participant in another clinical study. * Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment. * Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents. * Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state. * A known allergy to fluorescein, benoxinate, proparacaine or tropicamide. * Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. * Any ocular, systemic or neuro-developmental conditions that could influence refractive development.