- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501579
Study of Difluprednate in the Treatment of Uveitis
August 27, 2008 updated by: Sirion Therapeutics, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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New Albany, Indiana, United States, 47150
- John-Kenyon American Eye Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Roger Vogel, MD, Sirion Therapeutics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 13, 2007
First Posted (Estimate)
July 16, 2007
Study Record Updates
Last Update Posted (Estimate)
August 29, 2008
Last Update Submitted That Met QC Criteria
August 27, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Uveal Diseases
- Uveitis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Difluprednate
Other Study ID Numbers
- ST-601A-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
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Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
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AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
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The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
Clinical Trials on Difluprednate
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Alcon ResearchCompleted
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Sirion Therapeutics, Inc.Completed
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Sirion Therapeutics, Inc.Completed
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Sirion Therapeutics, Inc.CompletedPanuveitis | Uveitis
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Sirion Therapeutics, Inc.Completed
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Sirion Therapeutics, Inc.Completed
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Kafrelsheikh UniversityRecruiting
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Laboratorios Sophia S.A de C.V.Completed
-
Sirion Therapeutics, Inc.CompletedInflammationUnited States