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

Zhaoke Ophthalmology

Status and phase: Active, not recruiting; Phase 3

Conditions: Myopia

Treatments: Drug: Low dose atropine sulfate eye drops; Drug: placebo; Drug: Lower dose atropine sulfate eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT06209281

ZKO-ATP-202105-Mini-CHAMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 526 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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526 participants in 3 patient groups

Experimental group 1

Experimental group

Description:

1 drop each time, once every night at bedtime

Treatment:

Drug: Lower dose atropine sulfate eye drops

Drug: Low dose atropine sulfate eye drops

Experimental group 2

Experimental group

Description:

1 drop each time, once every night at bedtime

Treatment:

Drug: Low dose atropine sulfate eye drops

control group

Experimental group

Description:

1 drop each time, once every night at bedtime

Treatment:

Drug: placebo