跳至主要内容
临床试验/CTRI/2024/06/069019
CTRI/2024/06/069019招募中Phase 3 4

The effects of Topical Insulin on Dry eye disease in Type 2 Diabetic patients -A Randomised Control Trial

Dr Ritika Goel1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
Compare OSDI score and dry eye parameters before and after use of topical insulin

研究概览

简要总结

Diabetes mellitus is recognised as one of the important risk factors for Dry Eye Disease.Diabetics have shown to have lower Schirmer and Tear break up time measurements. Insulin receptor and insulin-like growth factor (IGF)-1 receptor are found in Plasma membrane and cytoplasm of corneal and conjunctival epithelial cells in a study conducted by Rocha et al.Topical Insulin plays a role in treatment of persistent epithelial defects and it has been found to decrease resolution time of neurotrophic ulcers. In Malaysia in January 2020  a Randomised trial by Azmi et al. to assess the short-term effects of topical insulin on the signs and symptoms of DED in DM patients. We will be doing a randomised control trial to study the effects of insulin eye drops in Type 2 diabetic patients with dry eye disease. Control group will be using polyethylene glycol eye drops .The drugs will be used for 8 weeks four times a day. OSDI score, tear break up time and schirmers 1 and 2 will be assessed at baseline and after the end of therapy . The Results will be analysed and compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Type 2 Diabetes mellitus Age above 30years Baseline OSDI score more than 14.

排除标准

  • Sjogren syndrome Already Instilling any eye drops Use of contact lens History of ocular Trauma/ chemical injury / ocular surgery On systemic insulin.

结局指标

主要结局

Compare OSDI score and dry eye parameters before and after use of topical insulin

时间窗: Topical insulin given for 8 weeks four times a day and the parameters will be assessed at baseline, 4 weeks and at 8 weeks

次要结局

  • Compare OSDI score & dry eye parameters in topical insulin & artificial tear substitute group(Artificial tears given for 8 weeks four times a day & parameters will be assessed at baseline, 4 weeks at 8 weeks. The results will be compared with topical insulin)

研究者

发起方
Dr Ritika Goel
申办方类型
Other [(self) ]
责任方
Principal Investigator
主要研究者

Professor Adeeb Alam khan

Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital

研究点 (1)

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