Conditions: Dry Eye Disease
Keywords: Dry eye ocular discomfort
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 722
Healthy volunteers: yes

Brief 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.

Detailed description:
Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Arms:
arm 1: Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure. arm 2: Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.

Interventions: intervention 1: Difluprednate 0.05% ophthalmic emulsion intervention 2: Difluprednate vehicle
Intervention descriptions: intervention 1: Topical ocular steroid intervention 2: Inactive ingredients used as Run-In and placebo comparator

Protocol document: