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 (Mini-CHAMP)

NCT06209281 Phase 3 ACTIVE_NOT_RECRUITING

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

Details

Lead sponsor	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	526
Start date	2022-05-13
Completion	2025-12

Conditions

• Myopia

Interventions

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

Primary outcomes

• Cycloplegic Autorefraction(low) — twelve months
  Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.

Countries

China