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

Phase 3

Active, not recruiting

• Conditions: Myopia
• Interventions: Drug: Lower dose atropine sulfate eye drops; Drug: placebo; Drug: Low dose atropine sulfate eye drops

• Registration Number: NCT06209281
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Brief 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.

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 Timeline

• Study Start: 2022-05-13
• Primary Completion: 2023-08-20
• Status Verified: 2024-01
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-17
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-16
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 526

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 1	Lower dose atropine sulfate eye drops	1 drop each time, once every night at bedtime
Experimental group 1	Low dose atropine sulfate eye drops	1 drop each time, once every night at bedtime
Experimental group 2	Low dose atropine sulfate eye drops	1 drop each time, once every night at bedtime
control group	placebo	1 drop each time, once every night at bedtime

Primary Outcome Measures

Name	Time	Method
Cycloplegic Autorefraction(low)	twelve months	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.

Secondary Outcome Measures

Name	Time	Method
Cycloplegic Autorefraction(lower)	twelve months	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.
Cycloplegic Autorefraction(SER)	twelve months	Between-group difference in the mean change from baseline in SER at visit M12

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China