Status:
ACTIVE_NOT_RECRUITING
A 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
6-12 years
Phase:
PHASE3
Brief Summary
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 myopi...
Detailed Description
Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children. The study was designed to enroll ...
Eligibility Criteria
Inclusion
- Child (female or male) aged 6 to 12 years.
- Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby 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
- Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
- Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
- Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
777 Patients enrolled
Trial Details
Trial ID
NCT06209320
Start Date
March 15 2022
End Date
August 1 2025
Last Update
July 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China