NCT06389110

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Myopia
• Myopia, Progressive

Interventions

Type	Name	Description
DRUG	Alleance®	Atropine sulfate 0.01%, ophthalmic solution.
DRUG	Placebo	Ophthalmic solution.

Timeline

• Start date: 2025-03-15
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2024-04-29
• Last updated: 2025-03-21

Locations

1 site across 1 country: Mexico