Status:
COMPLETED
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Lead Sponsor:
Sirion Therapeutics, Inc.
Conditions:
Anterior Uveitis
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
Detailed Description
The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for tr...
Eligibility Criteria
Inclusion
- Patients with endogenous anterior uveitis (including panuveitis)
- Patients with 20 or more anterior chamber cell within one field of the aqueous humor (Grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope
- Patients aged ≥20 years and \<75 years who could clearly express their subjective symptoms (Patients aged 20 years at giving informed consent were included in the study.)
- Patients giving written informed consent prior to initiation of the study
Exclusion
- Patients who did not meet all of the above inclusion criteria
- Patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug
- Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
- Patients with corneal erosion or corneal ulcer
- Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
- Patients with diabetes mellitus
- Patients with allergy to corticosteroids
- Patients requiring use of contact lens during the study period
- Women who were or might be pregnant
- Patients participating in other clinical studies within 6 months before initiation of the present study
- Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
- Patients with fibrins to such an extent that might affect measurement of flare
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2001
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00405496
Start Date
March 1 2000
End Date
April 1 2001
Last Update
November 30 2006
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