Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00616993
First received: February 4, 2008
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Inflammation
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: January 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Vehicle
Other: Placebo
Vehicle
Experimental: 1
Difluprednate
Drug: Difluprednate
Difluprednate

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616993

Locations
United States, Florida
Eye Associates of Fort Myers
Fort Myers, Florida, United States, 33901
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Study Chair: Roger Vogel, MD Sirion Therapeutics
  More Information

No publications provided

Responsible Party: Sirion Therapeutics
ClinicalTrials.gov Identifier: NCT00616993     History of Changes
Other Study ID Numbers: ST-601-004
Study First Received: February 4, 2008
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014