Myopia
Conditions
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.
Interventions
Administer to eyes
Administer to eyes
DRUGplacebo
Administer to eyes
Sponsors
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | twelve months | Between-group difference in the mean change from baseline in axial length at visit M12 |
| Crystalline Lens Thickness | twelve months | Between-group difference in the mean change from baseline in crystalline lens thickness at visit M12 |
Countries
China
Outcome results
None listed