Phase III Clinical Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay the Progression of Myopia and Axial Ocular Elongation in Children.
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.
• 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 until completion) or use of a highly effective contraceptive method, including hormonal contraception, barrier methods or intrauterine device).
• Refractive error of spherical equivalent between -0.50 to -6.00 D in each eye, measured by autorefraction and cycloplegic retinoscopy.
• Astigmatism less than -1.50 D in each eye, measured by autorefraction and retinoscopy.
• Spherical equivalent anisometropia ≤ 1.50 D measured by autorefraction and cycloplegic retinoscopy.
• Best corrected visual acuity (BCVA) normal for age.
• Normal binocular function and stereopsis for age.
• Normal intraocular pressure (\< 21 mmHg).
• Gestational age ≥ 32 weeks and birth weight \> 1500 g.