Status:
ACTIVE_NOT_RECRUITING
A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Lead Sponsor:
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Conditions:
Myopia
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief 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 ey...
Detailed Description
Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, onc...
Eligibility Criteria
Inclusion
- 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
- 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).
- Use of cycloplegic drops for dilated ocular exam was allowable.
- Heart rate persistently (for more than 10 minutes) \> 120 beats per minute.
- Allergy to study drugs.
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT06209281
Start Date
May 13 2022
End Date
December 1 2025
Last Update
July 30 2025
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China