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

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ClinicalTrials.gov Identifier: NCT00616993
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammation Drug: Difluprednate Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 2
Vehicle
Other: Placebo
Vehicle

Experimental: 1
Difluprednate
Drug: Difluprednate
Difluprednate




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sirion Therapeutics
ClinicalTrials.gov Identifier: NCT00616993     History of Changes
Other Study ID Numbers: ST-601-004
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

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