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

Information source: Sirion Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Difluprednate (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Sirion Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Roger Vogel, MD, Study Chair, Affiliation: Sirion Therapeutics

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.

Clinical Details

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

Primary outcome: 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

Secondary outcome: 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.

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: December 2007
Last updated: June 29, 2011

Page last updated: August 20, 2015

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