Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- The anterior chamber cell score was compared between baseline and after completion of the
研究概览
简要总结
The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
次要结局
- 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.