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

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

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

Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children.

The study was designed to enroll approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime.

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.

Inclusion Criteria:

1. Child (female or male) aged 6 to 12 years.
2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby 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. Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
2. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
3. Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;