At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Mapracorat +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.
The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
In Brief
A Phase 3 clinical trial evaluating Mapracorat and Vehicle for Cataract and 2 related conditions. Completed, enrolled 360 participants across 1 site.
Detailed Summary
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract, Inflammation, Surgery
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJul 2012
Primary CompletionSep 2013
Study CompletionOct 2013
TodayJul 2026
First PostedMay 4, 2012
Enrollment StartJul 1, 2012
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.2 years ago
Interventions
Mapracoratdrug
1 drop of study medication into the study eye four times daily (QID) for 14 days
Vehicledrug
1 drop of vehicle into the study eye QID for 14 days.