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NCT04877210 Clinical Trial

Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

Dry Eye Clinical Trial

Official title:
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators Compared to Standard Artificial Tears and Normal Saline in Diabetics With Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04877210
Other study ID # PPUKM
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 22, 2020
Est. completion date January 26, 2022

Study information
Verified date May 2021
Source Universiti Kebangsaan Malaysia Medical Centre
Contact Atikah bt Asini, M.D.
Phone +60178254335
Email atikahasini@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 60
Est. completion date January 26, 2022
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Topical Insulin
Insulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks

Locations
Country Name City State
Malaysia PPUKM Kuala Lumpur

Sponsors (1)
Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biochemical marker 1 Interleuikn 1-alpha 4 weeks
Primary Biochemical marker 2 Interleukin 6 4 weeks
Primary Biochemical marker 3 Matrix metallo-proteinase 9 4 weeks
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