Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

May 7, 2021 updated by: Mae-Lynn Catherine Bastion, Universiti Kebangsaan Malaysia Medical Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Insulin
Insulin (Actrapid) diluted in normal saline
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
Other Names:
  • Gutt insulin
Placebo Comparator: Normal Saline
Normal saline eyedrops
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
Other Names:
  • Gutt insulin
Active Comparator: Standard Artifical Tear
Gutt systane ultra
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
Other Names:
  • Gutt insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical marker 1
Time Frame: 4 weeks
Interleuikn 1-alpha
4 weeks
Biochemical marker 2
Time Frame: 4 weeks
Interleukin 6
4 weeks
Biochemical marker 3
Time Frame: 4 weeks
Matrix metallo-proteinase 9
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Mae-Lynn C. Bastion, PPUKM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

January 26, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPUKM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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