drugset / Trial / NCT06389110

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

NCT06389110

Phase 3 Recruiting 123 enrolled Laboratorios Sophia S.A de C.V.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-03-15
Primary completion
2027-10-30
Completion
2027-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atropine Other / unclassified 0.01 % Other

Indications