Ganyan-1 in Dry Eye: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 219
- 主要终点
- OSDI
研究概览
简要总结
Ganyan -1 for the patients with dry eye
详细描述
Objective
Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 and Age <=70, complaint of DED symptoms for 6 months or longer at screening.
- •ocular surface disease index (OSDI) score of 25 or higher.
- •tear film breakup time (TFBUT) of 5 seconds or less.
- •Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
- •CFS score of 4 or higher.
排除标准
- •History systemic autoimmune diseases and ocular/periocular malignancy.
- •Clinically relevant slitlamp findings or abnormal lid anatomy.
- •Active ocular allergies and active infection.
- •Pregnant or lactating women.
研究组 & 干预措施
Ganyan1
干预措施: Ganyan1 (Drug)
Ganyan1
干预措施: Sodium Hyaluronate (Drug)
1/2Ganyan1
干预措施: Sodium Hyaluronate (Drug)
1/2Ganyan1
干预措施: 1/2Ganyan1 (Drug)
Placebo
干预措施: Sodium Hyaluronate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
OSDI
时间窗: Baseline, week 2, 4, 8, 12 and 16
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100).
次要结局
- TBUT(Baseline, week 2, 4, 8, 12 and 16)
- Schirmer(Baseline, week 2, 4, 8, 12 and 16)
- SF-36(Baseline, week 2, 4, 8, 12 and 16)
- SAS(Baseline, week 2, 4, 8, 12 and 16)
- SDS(Baseline, week 2, 4, 8, 12 and 16)
- OQAS II(Baseline, week 2, 4, 8, 12 and 16)