RecruitingPhase 3NCT06389110

Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.

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.

Sponsor

Laboratorios Sophia S.A de C.V.

Enrollment

123 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Myopia Myopia, Progressive

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

Min Age: 3 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alleance® and a drug called Placebo for people with myopia and myopia, progressive. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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