A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Change From Baseline in Corneal Staining Score at Week 12
研究概览
简要总结
In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 20 or over
- •Moderate to Severe Dry Eye Disease Patients
- •Written informed consent to participate in the trial
排除标准
- •Any laser or ocular surgery within 2 months prior screening
- •Use of contact lenses
- •Any condition limiting patient's ability to participate in the trial
研究组 & 干预措施
Sodium Hyaluronate 0.15% mono-therapy
HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks
干预措施: TJO-018 (HA 0.15%) (Drug)
Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)
CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two ~ six times daily for 12 weeks.
干预措施: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) (Drug)
HA 0.15% + CsA 0.05% (combination therapy)
HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks.
干预措施: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05% (Drug)
结局指标
主要结局
Change From Baseline in Corneal Staining Score at Week 12
时间窗: Baseline and Week 12
After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome.
次要结局
- Change From Baseline in Corneal Staining Score at Week 4 and Week 8(Baseline, Week 4 and Week 8)