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

This study has been completed.

First Received: February 4, 2008 Last Updated: July 29, 2008 History of Changes

Sponsored by:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00616070

Purpose

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
Inflammation	Drug: Difluprednate Other: Placebo	Phase III

MedlinePlus related topics: Surgery

Drug Information available for: Difluprednate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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
1: Experimental Difluprednate	Drug: Difluprednate Difluprednate
2: Placebo Comparator Vehicle	Other: Placebo Vehicle

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: NCT00616070

Locations

United States, North Carolina
Charlotte Eye, Ear, Nose & Throat
Charlotte, North Carolina, United States, 28210

Sponsors and Collaborators

Sirion Therapeutics, Inc.

Investigators

Study Chair:

Roger Vogel, MD

Sirion Therapeutics

More Information

No publications provided

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

Study placed in the following topic categories:

Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009