Effects of Topical Insulin on Levels of Tear Inflammatory Mediators Compared to Standard Artificial Tears and Normal Saline in Diabetics With Dry Eye Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemical marker 2
研究概览
简要总结
60 samples are take to determine the effects of topical insulin on tear inflammatory mediators interleukin 1a, interleukin 6 and matrix metalloprotenase 9 in diabetics with dry eye disease.
详细描述
Tear samples are taken to compare the levels of inflammatory markers (IL 1a, IL6 and MMP 9) pre-and post treatment with topical insulin in normal saline compared to standard therapy and normal saline in diabetics with dry eyes and also to correlate the IL 1a, IL6 and MMP 9 levels with clinical outcomes in diabetics with dry eyes treated with topical insulin in normal saline, standard therapy and normal saline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all diabetics aged 18 - 50 years of age with at least mild OSDI scores
排除标准
- •Diabetics on contact lenses
- •Diabetic with history of ocular surgery in the preceding 3 months
- •Post menopausal women
- •Known mild dry eye with prior usage of topical therapy who are unable to discontinue
- •Known case of allergic eye disease
- •Sjogren's syndrome patients
- •Unwilling or unable to attend 6 follow up and sampling sessions
研究组 & 干预措施
Topical Insulin
Insulin (Actrapid) diluted in normal saline
干预措施: Topical Insulin (Drug)
Normal Saline
Normal saline eyedrops
干预措施: Topical Insulin (Drug)
Standard Artifical Tear
Gutt systane ultra
干预措施: Topical Insulin (Drug)
结局指标
主要结局
Biochemical marker 2
时间窗: 4 weeks
Interleukin 6
Biochemical marker 1
时间窗: 4 weeks
Interleuikn 1-alpha
Biochemical marker 3
时间窗: 4 weeks
Matrix metallo-proteinase 9
次要结局
未报告次要终点
研究者
Mae-Lynn Catherine Bastion
Professor Dr
Universiti Kebangsaan Malaysia Medical Centre