Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00616070
First received: February 4, 2008
Last updated: June 29, 2011
Last verified: June 2011

February 4, 2008
June 29, 2011
December 2007
March 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616070 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)
Not Provided

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Inflammation
  • Drug: Difluprednate
    Difluprednate
  • Other: Placebo
    Vehicle
  • Experimental: 1
    Difluprednate
    Intervention: Drug: Difluprednate
  • Placebo Comparator: 2
    Vehicle
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00616070
ST-601-003
Not Provided
Roger Vogel, MD, Sirion Therapeutics
Sirion Therapeutics, Inc.
Not Provided
Study Chair: Roger Vogel, MD Sirion Therapeutics
Sirion Therapeutics, Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP