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

Inflammation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616993
• Other study ID #: ST-601-004
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: June 29, 2011
• Start date: January 2008
• Est. completion date: March 2008

Study information

• Verified date: June 2011
• Source: Sirion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Difluprednate
Difluprednate

Other:
• Placebo
Vehicle

Locations

Country	Name	City	State
United States	Eye Associates of Fort Myers	Fort Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sirion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No