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Study of Difluprednate in the Treatment of Uveitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501579
First Posted: July 16, 2007
Last Update Posted: August 29, 2008
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.
Information provided by:
Sirion Therapeutics, Inc.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Sirion Therapeutics, Inc.:

  Eligibility

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
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
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
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

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 Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: August 29, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Fluprednisolone
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