An Observational Study To Assess The Clinical Changes Of Topical Cyclosporine 0.05 percent Ophthalmic Solution In The Management Of Mild To Moderate 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
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Dry eye sign and symptoms
研究概览
简要总结
Dry eye syndrome (DES) is a multifactorial disease of the ocular surface with tear film abnormalities, leading to eye discomfort, visual disturbance, tear film instability, and inflammation of the ocular surface.1 DES accounts for as many as 17%-25% of visits to ophthalmology clinics making it one of the most common ocular conditions. Patients with uncontrolled and chronic DES are at risk for ocular infections however, due to the natural defence mechanisms of the eye, overt intraocular infections are relatively uncommon.
Traditional therapies for DES mainly focus on the lubrication of the ocular surface with artificial tears. However, these treatments do not address the underlying ocular surface inflammation. Cyclosporine, an immunomodulatory agent, has been shown to block T-cell proliferation and receptor signal transduction. The cell-mediated inflammatory responses are modulated through the downregulation of IL-2 receptor expression and gene transcription.Because of the properties noted above, topical cyclosporine eye drops are indicated for the treatment of DES.
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
- •patients who will give written informed consent.
- •Patients with history of dry eye disease for a period of at least 6 months.
- •patients with corrected Snellen VA of 20/200.
排除标准
- •Patients with a history of hypersensitivity or intolerability to study medication or its component.
- •patient with presence of punctal plugs or past history of permanent punctal occlusion.
- •patient with lagophthalmos or clinically significant eyelid margin irregularity of either eye whether congenital or acquired.
结局指标
主要结局
Improvement in Dry eye sign and symptoms
时间窗: 4 months
次要结局
- Improvement in BCVA(4 months)
研究者
Dharamveer S Choudhary
Swai man singh medical college Jaipur
