Comparative study on efficacy between topical 0.05% Cyclosporine and topical 5% Lifitegrast in dry eye disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To compare the objective parameters which includes Schirmer tear test, Tear Break Up Time, Corneal and Conjunctival fluorescein staining, in patients treated with 0.05 percent Cyclosporine versus 5 percent Lifitegrast in dry eye disease
研究概览
简要总结
Dry eye disease (DED) is defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. The prevalence of this is 29.5% globally and 17.7% in India. Dry Eye Disease severely interferes with a number of crucial everyday tasks, and has become serious public health concern that needs greater funding and attention.
This study compares the efficacy between the two eye drops, 0.05% cyclosporine twice daily and 5% Lifitegrast twice daily for 45 days in 42 patients with moderate to severe dry eye disease. The primary outcome measures objective parameters which includes Schirmer tear test, Tear Break Up Time, Corneal and Conjunctival fluorescein staining and the secondary outcome measures subjective response with OSDI questionnaire on day 1, day 15 and day 45.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients who are diagnosed to have Moderate or Severe Dry eye disease 2 Who are compliant to medication 3 Willing to give consent for study.
排除标准
- •1 H/o using steroid eye drops in past one month 2 Presence of other ocular co morbidities.
- •glaucoma, lid abnormalities 3 Presence of MGD 4 H/o ocular trauma or infection in past 3 months 5 Corneal disorders affecting sensitivity 6 H/o Contact lens usage in past 3 months 7 Pregnant and lactating mothers 8 H/o intraocular surgery, refractive surgery in past 3 months 9 Presence of allergic conjunctivitis 10 H/o viral keratitis 11 Presence of pterygium 12 H/o punctal plug usage in last 3 months 13 H/o Steven-Jonson Syndrome, Ocular Pemphigoid 14 H/o usage of topical cyclosporine in past 3 months.
结局指标
主要结局
To compare the objective parameters which includes Schirmer tear test, Tear Break Up Time, Corneal and Conjunctival fluorescein staining, in patients treated with 0.05 percent Cyclosporine versus 5 percent Lifitegrast in dry eye disease
时间窗: At presentation, Day 15 and Day 45
次要结局
- To compare the subjective response (OSDI) in patients treated with 0.05% Cyclosporine versus 5% Lifitegrast in Dry eye disease(At presentation, Day 15 and Day 45)
研究者
Dr Lakshitha N
Sankara Eye Hospital, Shivamogga