At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 407 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.
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Loteprednol etabonate and Vehicle of Loteprednol Etabonate for Inflammation and Pain. Completed, enrolled 407 participants across 1 site.
Detailed Summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation, Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionSep 2010
Study CompletionOct 2010
TodayJul 2026
First PostedFeb 2, 2010
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.4 years ago
Interventions
Loteprednol etabonatedrug
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Vehicle of Loteprednol Etabonatedrug
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.