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

• Sponsor: Sirion Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00616070
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 40.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Inflammation	Drug: Difluprednate; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Difluprednate	Drug: Difluprednate; Difluprednate
Placebo Comparator: 2 Vehicle	Other: Placebo; Vehicle

Outcome Measures

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 [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. [Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00616070
• Other Study ID Numbers: ST-601-003
• First Posted: Feb 15, 2008
• Last Update Posted: Jun 30, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Inflammation; Difluprednate

Study Results

No Results Posted as of Jun 30, 2011