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

Phase 3

Completed

• Conditions: Inflammation
• Interventions: Drug: Difluprednate; Other: Placebo

• Registration Number: NCT00616070
• Lead Sponsor: Sirion Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Difluprednate	Difluprednate
2	Placebo	Vehicle

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Charlotte Eye, Ear, Nose & Throat; 🇺🇸 Charlotte, North Carolina, United States