drugset / Trial / NCT03942419

Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

NCT03942419

Phase 3 Terminated 438 enrolled Eyenovia Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.

Timeline

Start
2019-06-03
Primary completion
2024-10-31
Completion
2024-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Atropine Other / unclassified 0.01 % Other
Subject Atropine Other / unclassified 0.1 % Other

Indications