myopia
Conditions
Brief summary
Percentage of study eyes with a -0.75 D of progressive myopia at Month 36 defined as an increase in spherical equivalent of -0.75 D or greater (i.e., change from baseline ≥ -0.75) as assessed by cycloplegic autorefraction.
Detailed description
Change from baseline to Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction, Change from baseline to Month 36 in study eye axial length as measured by cycloplegic biometry (a device will be selected and the same device to be used throughout the duration of this study)
Interventions
DRUGAtropine Sulfate 0.01% Ophthalmic Solution
DRUGThe placebo for this trial will be composed of excipients used to manufacture the investigational drug but without the active drug substance.
Sponsors
Ocumension (Hong Kong) Ltd.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of study eyes with a -0.75 D of progressive myopia at Month 36 defined as an increase in spherical equivalent of -0.75 D or greater (i.e., change from baseline ≥ -0.75) as assessed by cycloplegic autorefraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction, Change from baseline to Month 36 in study eye axial length as measured by cycloplegic biometry (a device will be selected and the same device to be used throughout the duration of this study) | — |
Countries
Hungary, Ireland, Poland, Slovakia, Spain
Outcome results
None listed