drugset / Trial / NCT06431841

Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control

NCT06431841

Phase 4 Active not recruiting 111 enrolled Hospital San Carlos, Madrid
RandomizedParallel-groupSingle-blindTreatment

Summary

Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.

Timeline

Start
2022-02-23
Primary completion
2025-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Background Atropine Other / unclassified 0.025 %

Indications