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Study of Difluprednate in the Treatment of Uveitis

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ClinicalTrials.gov Identifier: NCT00501579
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : August 29, 2008
Information provided by:
Sirion Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Uveitis Drug: Difluprednate Drug: Prednisolone Acetate Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501579

United States, Indiana
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Study Chair: Roger Vogel, MD Sirion Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Sirion Therapeutics
ClinicalTrials.gov Identifier: NCT00501579     History of Changes
Other Study ID Numbers: ST-601A-001
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents