Status:
COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis
Lead Sponsor:
Sirion Therapeutics, Inc.
Conditions:
Uveitis
Panuveitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
Detailed Description
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-control...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of endogenous anterior uveitis or panuveitis
- Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
- Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
- Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
- Patients giving written informed consent prior to initiation of the study
Exclusion
- Patients who did not meet all of the above inclusion criteria
- Patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
- Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
- Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
- Patients with glaucoma or ocular hypertension
- Patients with corneal erosion or corneal ulcer
- Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
- Patients with allergy to similar drugs of difluprednate
- Patients requiring use of contact lens during the study period
- Women who were or might be pregnant, or lactating women
- Patients participating in another clinical study within 3 months before initiation of the present study
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00407056
Start Date
August 1 2002
End Date
June 1 2003
Last Update
December 4 2006
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