At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 139 enrolled
Drug / intervention
Levodopa/Carbidopa +2 moredrug
Likely dose
Levodopa/Carbidopa 0.76 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Levodopa as Treatment for Residual Amblyopia (ATS 17)
In Brief
A Phase 3 clinical trial evaluating Levodopa/Carbidopa, Placebo, and 1 other intervention for Amblyopia. Completed, enrolled 139 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmblyopia
CountriesUnited States
CollaboratorsNational Eye Institute (NEI)
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionJan 2014
Study CompletionApr 2014
TodayJul 2026
First PostedAug 30, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.8 years ago
Interventions
Levodopa/Carbidopadrug
Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
Placebodrug
Oral placebo tid
Patchingother
Two hours of daily patching