Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

National University of Malaysia (UKM)

Status and phase: Unknown; Phase 1

Conditions: Dry Eye

Treatments: Drug: Topical Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04877210

PPUKM

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

60 participants in 3 patient groups, including a placebo group

Topical Insulin

Experimental group

Description:

Insulin (Actrapid) diluted in normal saline

Treatment:

Drug: Topical Insulin

Normal Saline

Placebo Comparator group

Description:

Normal saline eyedrops

Treatment:

Drug: Topical Insulin

Standard Artifical Tear

Active Comparator group

Description:

Gutt systane ultra

Treatment:

Drug: Topical Insulin