Myopia progression in children
Conditions
Brief summary
The primary efficacy endpoint is the change of myopia determined by the spherical equivalent measured by autorefractor measurement with cycloplegia in the following 12 months after the beginning of low dose atropine treatment.
Detailed description
The secondary efficacy endpoints are the changes in - Axial eye growth - Anterior chamber depth - IOL-power for Spheris 209 - Lens thickness - Pupil size under photopic and scotopic conditions - Accommodation - Best corrected visual acuity and distance corrected near visual acuity - Atropine effects as a function of iris pigmentation in the course of 12 months of low dose Atropine treatment., Safety: Change from Baseline to Day 365 in: - IOP - Appearance of the macula Incidence of - Local adverse drug reactions - Systemic adverse drug reactions as assessed by the subject/caregiver. Incidence of adverse events assessed by investigator
Interventions
DRUGAtropine Sulfate 0.025% Eye Drops
DRUGsolution in single-dose container
DRUGAtropine Sulfate 0.005% Eye Drops
DRUGPlacebo Atropine Sulfate Eye Drops
DRUGAtropine Sulfate 0.05% Eye Drops
Sponsors
Pharma Stulln GmbH
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the change of myopia determined by the spherical equivalent measured by autorefractor measurement with cycloplegia in the following 12 months after the beginning of low dose atropine treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints are the changes in - Axial eye growth - Anterior chamber depth - IOL-power for Spheris 209 - Lens thickness - Pupil size under photopic and scotopic conditions - Accommodation - Best corrected visual acuity and distance corrected near visual acuity - Atropine effects as a function of iris pigmentation in the course of 12 months of low dose Atropine treatment., Safety: Change from Baseline to Day 365 in: - IOP - Appearance of the macula Incidence of - Local adverse drug reactions - Systemic adverse drug reactions as assessed by the subject/caregiver. Incidence of adverse events assessed by investigator | — |
Countries
Germany
Outcome results
None listed