At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
0.5% Loteprednol Etabonate Ophthalmic Ointment +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 Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating 0.5% Loteprednol Etabonate Ophthalmic Ointment and Vehicle of Loteprednol Etabonate Ophthalmic Ointment for Ocular Inflammation. Completed, enrolled 400 participants across 1 site.
Detailed Summary
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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 StartMar 2008
First PostedMar 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedMar 28, 2008
Enrollment StartMar 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.3 years ago
Interventions
0.5% Loteprednol Etabonate Ophthalmic Ointmentdrug
1/2 inch ribbon four times a day for 14 days
Vehicle of Loteprednol Etabonate Ophthalmic Ointmentdrug
1/2 inch ribbon four times a day for 14 days