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

Myopia Clinical Trial

— China-CHAMP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06209320
• Other study ID #: ZKO-ATP-202105-China-CHAMP
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 15, 2022
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 myopia in children

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 approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime. Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 777
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Child (female or male) aged 6 to 12 years.

2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.

3. If present, astigmatism of =1.50 D in each eye as measured by cycloplegic autorefraction.

4. Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.

Exclusion Criteria:

1. 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;

2. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;

3. 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;

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Lower dose atropine sulfate eye drops
administer to eyes
• Low dose atropine sulfate eye drops
administer to eyes
• placebo
administer to eyes

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between age and slow myopia progression	Relationship between age and slow in myopia progression (SER change from baseline)	24 months
Primary	Cycloplegic Autorefraction(SER)	Between-group difference in the mean change from baseline in SER at visit M24	24 months
Secondary	Axial Length	Between-group difference in the mean change from baseline in axial length at visit M24	24 months