Active — Not RecruitingPhase 3

A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

China526 participantsStarted 2022-05-13

Plain-language summary

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.

Who can participate

Age range6 Years – 10 Years

SexALL

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Inclusion criteria

✓. Child (female or male) aged 6 to 10 years.
✓. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction.
✓. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
✓. Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction.

Exclusion criteria

✕. History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
✕. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
✕. Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).
✕. Heart rate persistently (for more than 10 minutes) \> 120 beats per minute.
✕. Allergy to study drugs.

What they're measuring

Cycloplegic Autorefraction(low)

Timeframe: twelve months

Trial details

NCT IDNCT06209281

SponsorZhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-20

View on ClinicalTrials.gov More Myopia trials