Effects of Topical Insulin on Levels of Tear Inflammatory Mediators
Phase 1
- Conditions
- Dry Eye
- Interventions
- Drug: Topical Insulin
- Registration Number
- NCT04877210
- Lead Sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- all diabetics aged 18 - 50 years of age with at least mild OSDI scores
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topical Insulin Topical Insulin Insulin (Actrapid) diluted in normal saline Normal Saline Topical Insulin Normal saline eyedrops Standard Artifical Tear Topical Insulin Gutt systane ultra
- Primary Outcome Measures
Name Time Method Biochemical marker 2 4 weeks Interleukin 6
Biochemical marker 1 4 weeks Interleuikn 1-alpha
Biochemical marker 3 4 weeks Matrix metallo-proteinase 9
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPUKM
🇲🇾Kuala Lumpur, Malaysia