NCT01201798已完成3 期
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
研究概览
简要总结
The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of endogenous anterior uveitis in at least 1 eye.
- •The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
- •Age 2 years or older on day of consent.
- •Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
- •Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
- •Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
- •History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
- •History of steroid-induced elevation of intraocular pressure.
- •Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
- •History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
- •Corneal abrasion or ulceration in either eye.
- •Pregnancy or lactation.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Durezol
Experimental
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
干预措施: Difluprednate 0.05% ophthalmic emulsion (Drug)
Pred Forte
Active Comparator
Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
干预措施: Prednisolone acetate 1.0% ophthalmic suspension (Drug)
结局指标
主要结局
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
时间窗: Baseline (Day 0), Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
次要结局
- Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14(Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42)
- Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points(Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Proportion of Subjects With Anterior Chamber Cell Grade of 0(Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Proportion of Subjects With Anterior Chamber Cell Count of 0(Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0(Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Proportion of Subjects With Anterior Chamber Cell Grade ≤1(Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Proportion of Subjects Who Discontinued Due to Lack of Efficacy(Time to Event)
- Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points(Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
- Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits(Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42)
研究者
研究点 (1)
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