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

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

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

Condition Intervention Phase
Drug: Difluprednate
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sirion Therapeutics, Inc.:

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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

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. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Difluprednate
Placebo Comparator: 2
Other: Placebo


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00616070

United States, North Carolina
Charlotte Eye, Ear, Nose & Throat
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Study Chair: Roger Vogel, MD Sirion Therapeutics
  More Information

No publications provided

Responsible Party: Roger Vogel, MD, Sirion Therapeutics Identifier: NCT00616070     History of Changes
Other Study ID Numbers: ST-601-003
Study First Received: February 4, 2008
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses processed this record on April 17, 2014