At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
LE Geldrug
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.
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating LE Gel for Pharmacokinetics. Completed, enrolled 12 participants across 1 site.
Detailed Summary
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionJan 2013
Study CompletionApr 2013
TodayJul 2026
First PostedNov 29, 2012
Enrollment StartJan 1, 2013
Primary CompletionJan 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 13.6 years ago
Interventions
LE Geldrug
Single drop of LE Gel 0.5% administered to the study eye on visit 2