NCT00406887已完成3 期
Phase 3 Confirmatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Including Panuveitis).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- The difference from the baseline in anterior chamber cell score on Day 14
研究概览
简要总结
The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
详细描述
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with endogenous anterior uveitis or panuveitis
- •Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
- •Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
- •Patients provided 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 received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
- •Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
- •Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
- •Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
- •Patients with glaucoma or ocular hypertension
- •Patients with corneal abrasion or ulcer
- •Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
- •Patients with allergy to similar drugs such as other corticosteroids
- •Patients requiring use of contact lens during the study period
- •Women who are or might be pregnant, or lactating women
- •Patients participating in another clinical study within the past 3 months before initiation of the present study
结局指标
主要结局
The difference from the baseline in anterior chamber cell score on Day 14
was compared between the two groups.
次要结局
- The differences from the baseline in anterior chamber cell score on Days 3 and 7
- were compared between the two groups.
- The numbers of patients with an anterior chamber cell score of 0 on Days 7 and
- 14 were compared between the two groups.
- The differences from the baseline in total sign and symptom scores on Days 3, 7
- and 14 were compared between the two groups.
- The numbers of patients with an anterior chamber cell score of 1 or less on Days
- 3, 7 and 14 were compared between the two groups.
研究者
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