Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation After Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
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 postoperative inflammation.
详细描述
The objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
- •Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms
- •Patients providing written informed consent prior to the start of the study
- •Inpatients (patients were allowed to be discharged from the hospital during the study period)
排除标准
- •Patients who did not meet any of the above inclusion criteria
- •Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
- •Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
- •Patients with corneal abrasion or ulcer
- •Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease
- •Patients with diabetes who met any of the following criteria
- •HbA1C was 9.0% within 1 month prior to obtaining informed consent.
- •Proliferative diabetic retinopathy was present.
- •Rubeosis iridis was present.
- •Patients with allergy to steroids
- •Patients requiring the use of contact lens during the study period
- •Women who were or might be pregnant
- •Patients participating in another clinical study within 6 months prior to the start of the present study
- •Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid)
- •Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification
- •Patients with fibrins or posterior rupture at baseline (F0)
结局指标
主要结局
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
次要结局
- with the baseline total score (S0).
- The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
- As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
- (cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
- total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
- compared between the 0.002% and 0.05% difluprednate groups to identify when the
- between-group difference in the effect of difluprednate became significant.