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

Myopia Clinical Trial

— Mini-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: NCT06209281
• Other study ID #: ZKO-ATP-202105-Mini-CHAMP
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 13, 2022
• Est. completion date: August 2024

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

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.

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, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。

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: 526
• Est. completion date: August 2024
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

1. Child (female or male) aged 6 to 10 years.

2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by 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. History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).

2. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).

3. 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.

4. Heart rate persistently (for more than 10 minutes) > 120 beats per minute.

5. Allergy to study drugs.

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	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

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	Axial Length	Between-group difference in the mean change from baseline in axial length at visit M12	twelve months
Other	Crystalline Lens Thickness	Between-group difference in the mean change from baseline in crystalline lens thickness at visit M12	twelve months
Primary	Cycloplegic Autorefraction(low)	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.	twelve months
Secondary	Cycloplegic Autorefraction(lower)	Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with lower atropine versus placebo.	twelve months
Secondary	Cycloplegic Autorefraction(SER)	Between-group difference in the mean change from baseline in SER at visit M12	twelve months