Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures. * Female subjects, who have already presented their menarche, must have a negative urine pregnancy test at the time of screening. * Female subjects who have already experienced menarche should secure a method of contraception for the duration of the study. Acceptable contraceptive methods include abstinence (defined as abstinence from heterosexual intercourse from study entry unti