Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2022-01-26

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Topical Insulin

Insulin (Actrapid) diluted in normal saline

Group Type EXPERIMENTAL

Topical Insulin

Intervention Type DRUG

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

Normal Saline

Normal saline eyedrops

Group Type PLACEBO_COMPARATOR

Topical Insulin

Intervention Type DRUG

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

Standard Artifical Tear

Gutt systane ultra

Group Type ACTIVE_COMPARATOR

Topical Insulin

Intervention Type DRUG

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

Interventions

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Topical Insulin

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

Intervention Type DRUG

Other Intervention Names

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Gutt insulin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes