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Study of Difluprednate in the Treatment of Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501579
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.

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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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


Locations
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United States, Indiana
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
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Study Chair: Roger Vogel, MD Sirion Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chief Medical Officer, Sirion Therapeutics
ClinicalTrials.gov Identifier: NCT00501579    
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:
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Uveitis
Uveal Diseases
Eye Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Difluprednate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents