A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children (China-CHAMP)

NCT06209320 Phase 3 ACTIVE_NOT_RECRUITING

A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children

Details

Lead sponsor	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	777
Start date	2022-03-15
Completion	2025-08

Conditions

• Myopia

Interventions

• Lower dose atropine sulfate eye drops
• Low dose atropine sulfate eye drops
• placebo

Primary outcomes

• Cycloplegic Autorefraction(SER) — 24 months
  Between-group difference in the mean change from baseline in SER at visit M24

Countries

China