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

Myopia Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial. Primary Objective: - To demonstrate the superiority of Alleance® compared to placebo in delaying myopia progression in children. Specific objectives: - To demonstrate the reduction in progression in spherical equivalent in children using Alleance® compared to placebo after 12 months of treatment. - To demonstrate the reduction in progression in ocular axial length in children using Alleance® compared to placebo, after 12 months of treatment. Secondary objectives: - To compare the incidence of adverse events related to the interventions. - Compare the incidence of photophobia between interventions. - To assess pupillary diameter between the interventions. - To assess best-corrected far visual acuity between interventions. - To assess near best-corrected visual acuity between interventions. - To assess the amplitude of accommodation between interventions. - Assess intraocular pressure (IOP) between procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06389110
Study type Interventional
Source Laboratorios Sophia S.A de C.V.
Contact Alejandra Sanchez-Rios, MD
Phone 33 3001 4200
Email alejandra.sanchez@sophia.com.mx
Status Not yet recruiting
Phase Phase 3
Start date December 30, 2024
Completion date June 30, 2027
View Details
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