Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)
- Registration Number
- NCT00616993
- Lead Sponsor
- Sirion Therapeutics, Inc.
- Brief Summary
The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Scheduled for unilateral ocular surgery.
Exclusion Criteria
- Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Vehicle 1 Difluprednate Difluprednate
- Primary Outcome Measures
Name Time Method The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups. Day 14
- Secondary Outcome Measures
Name Time Method The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups. Day 7
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of difluprednate in reducing post-ocular surgery inflammation?
How does difluprednate compare to other corticosteroids like loteprednol in managing post-surgical ocular inflammation?
Are there specific biomarkers that correlate with difluprednate efficacy in post-ocular surgery inflammation?
What are the potential adverse events associated with difluprednate use in post-surgical ocular inflammation?
What are the current developments in glucocorticoid receptor modulators for post-ocular surgery inflammation treatment?
Trial Locations
- Locations (1)
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Eye Associates of Fort Myers🇺🇸Fort Myers, Florida, United States