Comparison of efficacy and adverse effects of Cyclosporine 0.09% and Lifitegrast 5% in patients with dry eye disease- A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement of symptoms of dry eye disease
研究概览
简要总结
Background
Dry eye disease also known as Keratoconjunctivitis sicca is a complex disorder of ocular surface characterized by symptoms of visual disturbances eye discomforts and dryness due to tear film instability.
Purpose
Comparison of efficacy and adverse effects of Cyclosporine 0.09% and Lifitegrast 5% in patients with dry eye disease. Patients included in the study are those who are having clinical signs of dry eye disease and have been advised Cyclosporine 0.09% orLifitegrast 5%.
Adverse Effects
Adverse effects of Cyclosporine 0.09% includes burning stinging conjunctival hyperemia and reactivations of Herpes Simplex Keratitis.
Adverse effects of Lifitegrast 5% includes transient instillation site irritation eye irritation decreased visual acuity blepharitis blurred vision and altered taste sensation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects included in this study are those who are above 18 years of age with clinical signs of dry eye disease and have been advised Cyclosporine 0.09% or Lifitegrast 5%.
排除标准
- •Patients who have undergone any other forms of dry eye therapy like IPL, IRPL, Lipiflow
- •Patients not willing to participate in our study
- •Patients who are not willing to follow-up in our study.
结局指标
主要结局
Improvement of symptoms of dry eye disease
时间窗: at base line 1 Month and 6 Months
次要结局
- Discontinued any drug due to adverse effect(base line 1 month & 6 months)
研究者
Sarama S Raj
Chaithanya Eye Hospital And Research Institute