Status:
COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Lead Sponsor:
Sirion Therapeutics, Inc.
Conditions:
Anterior Uveitis
Panuveitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
Detailed Description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamet...
Eligibility Criteria
Inclusion
- Patients diagnosed with endogenous anterior uveitis or panuveitis
- Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
- Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
- Patients provided written informed consent prior to initiation of the study
Exclusion
- Patients who did not meet all of the above inclusion criteria
- Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
- Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
- Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
- Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
- Patients with glaucoma or ocular hypertension
- Patients with corneal abrasion or ulcer
- Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
- Patients with allergy to similar drugs such as other corticosteroids
- Patients requiring use of contact lens during the study period
- Women who are or might be pregnant, or lactating women
- Patients participating in another clinical study within the past 3 months before initiation of the present study
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00406887
Start Date
August 1 2002
End Date
November 1 2003
Last Update
December 4 2006
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