Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
Information source: Sirion Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammation
Intervention: Difluprednate (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Sirion Therapeutics, Inc. Official(s) and/or principal investigator(s): Roger Vogel, MD, Study Chair, Affiliation: Sirion Therapeutics
Summary
The purpose of this phase III study is to determine the safety and efficacy of difluprednate
in the management of inflammation following ocular surgery.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Charlotte Eye, Ear, Nose & Throat, Charlotte, North Carolina 28210, United States
Additional Information
Starting date: December 2007
Last updated: June 29, 2011
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