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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-13

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group 1

1 drop each time, once every night at bedtime

Group Type EXPERIMENTAL

Lower dose atropine sulfate eye drops

Intervention Type DRUG

Administer to eyes

Low dose atropine sulfate eye drops

Intervention Type DRUG

Administer to eyes

Experimental group 2

1 drop each time, once every night at bedtime

Group Type EXPERIMENTAL

Low dose atropine sulfate eye drops

Intervention Type DRUG

Administer to eyes

control group

1 drop each time, once every night at bedtime

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Administer to eyes

Interventions

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Lower dose atropine sulfate eye drops

Administer to eyes

Intervention Type DRUG

Low dose atropine sulfate eye drops

Administer to eyes

Intervention Type DRUG

placebo

Administer to eyes

Intervention Type DRUG

Other Intervention Names

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Eye drops Eye drops Eye drops

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No