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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616993
First Posted: February 15, 2008
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sirion Therapeutics, Inc.
  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 (Participant, 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: Sirion Therapeutics
ClinicalTrials.gov Identifier: NCT00616993     History of Changes
Other Study ID Numbers: ST-601-004
First Submitted: February 4, 2008
First Posted: February 15, 2008
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