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Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04877210
Enrollment
60
Registered
2021-05-07
Start date
2020-10-22
Completion date
2022-01-26
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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

Interventions

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

Sponsors

Universiti Kebangsaan Malaysia Medical Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical marker 14 weeksInterleuikn 1-alpha
Biochemical marker 24 weeksInterleukin 6
Biochemical marker 34 weeksMatrix metallo-proteinase 9

Countries

Malaysia

Contacts

Primary ContactAtikah bt Asini, M.D.
atikahasini@yahoo.com+60178254335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026