Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Study Overview
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Brief Summary
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The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Detailed Description
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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.

Official Title
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Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

Conditions
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Anterior Uveitis

Intervention / Treatment
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* Drug: Difluprednate Ophthalmic Emulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Difluprednate Ophthalmic Emulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (142 days) from baseline. |  |  |