At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 326 enrolled
Drug / intervention
Loteprednol Etabonate Gel (BID) +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.
Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Loteprednol Etabonate Gel (BID) and Vehicle Gel (BID) for Inflammation and 2 related conditions. Completed, enrolled 326 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation, Pain, Cataract
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartSep 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedAug 5, 2014
Enrollment StartSep 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.9 years ago
Interventions
Loteprednol Etabonate Gel (BID)drug
One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
Vehicle Gel (BID)drug
One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days