Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children.
Children aged between 3 to 12 years
Male or female sex.
The parent(s) or legal guardian(s) must voluntarily give their signed informed consent.
From the age of 7 years and older, the subject's willingness to participate in the research study will be expressed in writing. In the case of subjects under 7 years of age, only the signature of the informed consent by the parent(s) or legal guardian(s) will be required, provided that the subject's verbally expressed will is respected.
Allergy to atropine or any of the components of the investigational products.
Previous or current use of atropine, orthokeratology lens or other optical methods for myopia control (bifocal, progressive, multifocal, or defocusing air or contact lenses). Only prior or current use of frame lenses or monofocal contact lenses for the correction of myopic or myopic/astigmatic refractive error will be allowed.
Heart rate > 120 beats per minute persistently (for more than 10 minutes) at the time of screening/baseline visit.
History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).
Parallel
Alleance®
DrugAtropine sulfate 0.01%, ophthalmic solution.
Placebo
DrugOphthalmic solution.
Changes in the spherical equivalent
The reduction in progression in spherical equivalent, will be calculated by combining the spherical component (E) and the cylindrical component (C) of the refractive error, independently for each eye: EE=E+C2
Changes in axial eye length
The reduction in progression in ocular axial length will be measured utilizing optical biometry.
Incidence of unexpected adverse events related to the interventions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Incidence of photophobia between interventions
Any signs of uncomfortable vision, based on the diffusion of light through the ocular media or on a transient or permanent lack of adaptation. The subjects will be questioned regarding this symptoms' incidence.
Changes in pupillary diameter between the interventions
The changes in pupillary diameter will be evaluated through the optical biometer or by the OPD scan Topographer III®.
Changes in Best Corrected Visual Acuity (BCVA)
The best corrected visual acuity will be evaluated through the Snellen chart in subjects ≥ 6 years of age. The LEA chart is used to assess visual acuity in children older than 30 months of age.
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