Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Symptoms Assessment Questionnaire iN Dry Eye
研究概览
简要总结
Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery
详细描述
To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Postmenopausal women for whom cataract surgery has been scheduled
- •Stage N2-3; C1-2 according (Lens Opacities classification System) LOCS
- •Willing to sign informed consent and fully participate to all length of the study
- •Patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease
- •Patient with no history of ocular surgery
- •Patients without any previous or concomitant ocular diseases
排除标准
- •Patients under topical or systemic anti- inflammatory drugs Patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs
- •Patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics)
- •Patients with a history of allergic, congenital, autoimmune systemic diseases
- •Patients who have undergone previous eye surgery
- •Ocular or peri-ocular malignancies or premalignant conditions
- •Active or suspected ocular or peri-ocular infection.
- •Complicated Cataract Surgery
- •Patients with a positive pregnancy testAllergy or reaction history to study drug
- •Patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug
研究组 & 干预措施
Study group
25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment
干预措施: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion (Drug)
Vehicle group
25 patients > 75 years old with vehicle preoperative treatment
干预措施: cationorm eye drops (Device)
结局指标
主要结局
Symptoms Assessment Questionnaire iN Dry Eye
时间窗: 4 months
SANDE (frequency and severity scores; 0-100)
National Eye Institute grading scale
时间窗: 4 months
NEI corneal staining ( n/15 score; 0-15)
Rate of tears' production
时间窗: 4 months
Schirmer test (mm/5min)
Tears Break Up Time
时间窗: 4 months
T-BUT (Seconds)
次要结局
- Biomarkers' expression in conjunctival epithelial cells(4 months)
研究者
Antonio Di Zazzo
Principal Investigator
Campus Bio-Medico University