Efficacy and Safety of Topical Insulin on Ocular Surface Stability, Tear Film and Symptomatology in Patients with Dry Eye Disease and Diabetes Mellitus: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- OSDI symptom score
研究概览
简要总结
The long-term effects of topical insulin on ocular surface parameters, dry eye symptomatology and tear biochemical markers in mild-moderate dry eye patients with diabetes has not been studied. Topical Insulin therapy may have a role in improving the nerve density, health of the corneal epithelial cells, lacrimal gland and meibomian gland function ultimately leading to a better tear film and stability of the diabetic ocular surface.Topical insulin therapy may improve lacrimal gland function, tear film stability, meibomian gland and dry eye symptomatology in diabetic patients with dry eye disease.The study aims to evaluate the impact of topical Insulin therapy on the dry eye related symptomatology, ocular surface parameters, tear inflammatory markers and tear biochemical parameters in diabetic dry eye patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type II Diabetic patients, >18 years of age, diagnosed with mild-moderate dry eye and consenting to participate in the study shall be enrolled.
- •Dry eye shall be diagnosed based on Ocular Surface Disease Index (OSDI) score greater than 13, and TBUT < 10 seconds or Schirmer I score <10 mm.
排除标准
- •1.Patients with severe dry eye ; OSDI>33
- •Schirmer I test less than 5 mm in either eye at screening.
- •3.Patients with any uncontrolled severe systemic disease that may affect the eye (other than Diabetes Mellitus).
- •4.Patients with use of any systemic medication that may affect tear film or vision within 3 months of screening .
- •5.Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
- •6.Current or previous use of topical ocular medication within 2 weeks of screening and use of contact lens anticipated during the study or use 3 months prior to screening.
- •7.Patients with raised intraocular pressure on screening and known cases of glaucoma shall also be excluded.
结局指标
主要结局
OSDI symptom score
时间窗: At 6 months
次要结局
- Change in ocular surface stabilty ( TBUT, Schirmer,lipid layer thickness, tear meniscus height)(Meibography)