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RECRUITING
NCT06389110
PHASE3

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

Sponsor: Laboratorios Sophia S.A de C.V.

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

3 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2025-03-15

Completion Date

2027-10-30

Last Updated

2025-03-21

Healthy Volunteers

Yes

Interventions

DRUG

Alleance®

Atropine sulfate 0.01%, ophthalmic solution.

DRUG

Placebo

Ophthalmic solution.

Locations (1)

Innovación Y Desarrollo En Ciencias de La Salud S de Rl de Cv

Mexico City, Mexico