The Effect of Topical 0.05% Cyclosporine Eye Drops on Diabetic Patients with Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ocular surface disease index (OSDI)
研究概览
简要总结
The objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.
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
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. Age: 50 to 70 years old; II. Gender: No restriction; III. Meets the diagnostic criteria for dry eye: Refer to the 2020 Chinese Expert Consensus on Diagnostic Criteria for Dry Eye.
- •IV. Meets the diagnostic criteria for diabetes: History of type 2 diabetes with a course of ≥5 years; Diagnosis refers to the 1999 WHO Diagnostic Criteria for Diabetes.
- •V. Provision of written informed consent.
排除标准
- •I. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
- •II. Uncontrolled systemic disease. III.Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
研究组 & 干预措施
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
干预措施: artificial tear eyedrops (Drug)
0.05% cyclosporine eyedrops combined with artificial tear eyedrops
干预措施: 0.05% cyclosporine eyedrops (Drug)
artificial tear eyedrops
干预措施: artificial tear eyedrops (Drug)
结局指标
主要结局
ocular surface disease index (OSDI)
时间窗: from baseline to 3 months after treatment
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Tear break-up time (TBUT)(s)
时间窗: from baseline to 3 months after treatment
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Corneal fluorescein staining (CFS)
时间窗: from baseline to 3 months after treatment
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15.
Schirmer I test (SIt) (mm/5 minutes)
时间窗: from baseline to 3 months after treatment
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
Lissamine green staining
时间窗: from baseline to 3 months after treatment
To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.
次要结局
- corneal sensitivity (range, 60-0 mm)(from baseline to 3 months after treatment)
- the concentration of Interleukin-1β (IL-1β) (pg/ml)(from baseline to 3 months after treatment)
- the concentration of Interleukin-6 (IL-6) (pg/ml)(from baseline to 3 months after treatment)
- the concentration of Interleukin-10 (IL-10) (pg/ml)(from baseline to 3 months after treatment)
- the concentration of Interleukin-17A (IL-17A) (pg/ml)(from baseline to 3 months after treatment)