MedTrace Logo

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

NCT06389110 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Myopia
  • Myopia, Progressive

Interventions

DRUG

Alleance®

Atropine sulfate 0.01%, ophthalmic solution.

DRUG

Placebo

Ophthalmic solution.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389110 on ClinicalTrials.gov