Study of Difluprednate in the Treatment of Uveitis

This study has been completed.

Sponsored by:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00501579

Purpose

The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

Condition	Intervention	Phase
Uveitis	Drug: Difluprednate Drug: Prednisolone Acetate	Phase III

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Difluprednate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of endogenous anterior uveitis in at least 1 eye

Exclusion Criteria:

Presence of intermediate uveitis, posterior uveitis or panuveitis
Corneal abrasion
Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
Allergy to similar drugs, such as other corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501579

Locations

United States, Indiana
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150

Sponsors and Collaborators

Sirion Therapeutics, Inc.

Investigators

Study Chair:

Roger Vogel, MD

Sirion Therapeutics

More Information

Responsible Party:	Sirion Therapeutics ( Chief Medical Officer )
Study ID Numbers:	ST-601A-001
Study First Received:	July 13, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00501579
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Methylprednisolone
Uveitis
Eye Diseases
Prednisolone

Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents

Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009