Back to resultsStudy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
Primary Purpose
Inflammation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Difluprednate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility 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.
Sites / Locations
- Charlotte Eye, Ear, Nose & Throat
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Difluprednate
Vehicle
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
NCT ID
NCT00616070
First Posted
February 4, 2008
Last Updated
June 29, 2011
Sponsor
Sirion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00616070
Brief Title
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sirion Therapeutics, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Difluprednate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Difluprednate
Intervention Description
Difluprednate
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
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
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
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.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Vogel, MD
Organizational Affiliation
Sirion Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Charlotte Eye, Ear, Nose & Throat
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
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