Study of Difluprednate in the Treatment of Uveitis

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00501579
First received: July 13, 2007
Last updated: August 27, 2008
Last verified: August 2008
  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-Blind

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Sirion Therapeutics, Inc.

Additional 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
Study First Received: July 13, 2007
Last Updated: August 27, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Fluprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Difluprednate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on August 26, 2014