At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
Difluprednate ophthalmic emulsion, 0.05% +1 moredrug
Likely dose
Not stated in 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 Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred Forte™) QID for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
In Brief
A Phase 3 clinical trial evaluating Difluprednate ophthalmic emulsion, 0.05% and Prednisolone acetate ophthalmic suspension, 1.0% for Cataracts and Inflammation. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataracts, Inflammation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartAug 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedMay 14, 2010
Enrollment StartAug 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.1 years ago
Interventions
Difluprednate ophthalmic emulsion, 0.05%drug
Topical ocular administration
Prednisolone acetate ophthalmic suspension, 1.0%drug
Topical ocular administration