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Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

Sponsor
Universiti Kebangsaan Malaysia Medical Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04877210
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
15.1
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical Insulin
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 22, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Jan 26, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biochemical marker 1 [4 weeks]

      Interleuikn 1-alpha

    2. Biochemical marker 2 [4 weeks]

      Interleukin 6

    3. Biochemical marker 3 [4 weeks]

      Matrix metallo-proteinase 9

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PPUKM Kuala Lumpur Malaysia

    Sponsors and Collaborators

    • Universiti Kebangsaan Malaysia Medical Centre

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mae-Lynn Catherine Bastion, Professor Dr, Universiti Kebangsaan Malaysia Medical Centre
    ClinicalTrials.gov Identifier:
    NCT04877210
    Other Study ID Numbers:
    • PPUKM
    First Posted:
    May 7, 2021
    Last Update Posted:
    May 11, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Insulin
    Insulin, Globin Zinc

    Study Results

    No Results Posted as of May 11, 2021