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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Lower dose atropine sulfate eye drops; Drug: Low dose atropine sulfate eye drops; Drug: placebo

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 526
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1; 1 drop each time, once every night at bedtime	Drug: Lower dose atropine sulfate eye drops; Administer to eyes; Other Names: Eye drops; Drug: Low dose atropine sulfate eye drops; Administer to eyes; Other Names: Eye drops
Experimental: Experimental group 2; 1 drop each time, once every night at bedtime	Drug: Low dose atropine sulfate eye drops; Administer to eyes; Other Names: Eye drops
Experimental: control group; 1 drop each time, once every night at bedtime	Drug: placebo; Administer to eyes; Other Names: Eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cycloplegic Autorefraction(SER)	Between-group difference in the mean change from baseline in SER at visit M12	twelve months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Length	Between-group difference in the mean change from baseline in axial length at visit M12	twelve months
Crystalline Lens Thickness	Between-group difference in the mean change from baseline in crystalline lens thickness at visit M12	twelve months

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Investigators: Principal Investigator: Xiaomei Qu, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): August 20, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Pharmaceutical Solutions; Mydriatics; Ophthalmic Solutions; Atropine
• Other Study ID Numbers: ZKO-ATP-202105-Mini-CHAMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No