NCT00407056已完成3 期
Phase 3 Open-Labeled Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Severe 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
- 20
- 主要终点
- The anterior chamber cell score was compared between baseline and Day 14.
研究概览
简要总结
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe 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 in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with a diagnosis of endogenous anterior uveitis or panuveitis
- •Patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4)
- •Patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day)
- •Patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms
- •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 initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug
- •Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product)
- •Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug
- •Patients with glaucoma or ocular hypertension
- •Patients with corneal erosion or corneal ulcer
- •Patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection
- •Patients with allergy to similar drugs of difluprednate
- •Patients requiring use of contact lens during the study period
- •Women who were or might be pregnant, or lactating women
- •Patients participating in another clinical study within 3 months before initiation of the present study
结局指标
主要结局
The anterior chamber cell score was compared between baseline and Day 14.
次要结局
- The anterior chamber cell score was compared between baseline and Days 3 and 7.
- The total symptom score (sum of eye pain, photophobia, blurred
- vision, foreign body sensation and lacrimation scores) and total
- sign score (sum of anterior chamber cell, anterior chamber flare,
- ciliary hyperemia, keratic precipitate and synechia of iris and
- posterior scores) were compared between baseline and Days 3, 7
- and 14.
研究者
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