Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Study Details
Study Description
Brief Summary
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.
The secondary objective was to establish the evaluation system for a dose-finding study.
Study Design
Outcome Measures
Primary Outcome Measures
- The anterior chamber cell score was compared between baseline and after completion of the []
- study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the []
- reduction of anterior chamber cell. []
Secondary Outcome Measures
- The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value []
- (baseline/after completion of the study treatment ratio), as measured with a laser flare cell []
- meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical []
- signs and symptoms after completion of the study treatment (142 days) from baseline. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with endogenous anterior uveitis (including panuveitis)
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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
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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.)
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Patients giving written informed consent prior to initiation of the study
Exclusion Criteria:
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Patients who did not meet all of the above inclusion criteria
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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
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Patients with glaucoma or ocular hypertension (IOP ≥21 mmHg)
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Patients with corneal erosion or corneal ulcer
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Patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases
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Patients with diabetes mellitus
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Patients with allergy to corticosteroids
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Patients requiring use of contact lens during the study period
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Women who were or might be pregnant
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Patients participating in other clinical studies within 6 months before initiation of the present study
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Patients with sensitivity to steroids(Patients who previously exhibited increased IOP after instillation of a steroid ophthalmic solution)
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Patients with fibrins to such an extent that might affect measurement of flare
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sirion Therapeutics, Inc.
Investigators
- Study Chair: Kanjiro Masudo, Director, Kanto Rosai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJE2079/2-02-PC