At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 722 enrolled
Drug / intervention
Difluprednate 0.05% ophthalmic emulsion +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 Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
In Brief
A Phase 2 clinical trial evaluating Difluprednate 0.05% ophthalmic emulsion and Difluprednate vehicle for Dry Eye Disease. Completed, enrolled 722 participants across 1 site.
Detailed Summary
The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartFeb 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedJan 13, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.5 years ago
Interventions
Difluprednate 0.05% ophthalmic emulsiondrug
Topical ocular steroid
Difluprednate vehicleother
Inactive ingredients used as Run-In and placebo comparator