At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
Loteprednol Etabonate +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.
Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Loteprednol Etabonate and Vehicle of Ophthalmic Loteprednol Etabonate for Ocular Inflammation. Completed, enrolled 400 participants across 1 site.
Detailed Summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionMay 2009
Study CompletionJun 2009
TodayJul 2026
First PostedJun 17, 2008
Enrollment StartJun 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.0 years ago
Interventions
Loteprednol Etabonatedrug
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
Vehicle of Ophthalmic Loteprednol Etabonatedrug
Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.