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Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Topical Insulin
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PPUKMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Topical Insulin

Normal Saline

Standard Artifical Tear

Arm Description

Insulin (Actrapid) diluted in normal saline

Normal saline eyedrops

Gutt systane ultra

Outcomes

Primary Outcome Measures

Biochemical marker 1
Interleuikn 1-alpha
Biochemical marker 2
Interleukin 6
Biochemical marker 3
Matrix metallo-proteinase 9

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
May 7, 2021
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04877210
Brief Title
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
January 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical Insulin
Arm Type
Experimental
Arm Description
Insulin (Actrapid) diluted in normal saline
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline eyedrops
Arm Title
Standard Artifical Tear
Arm Type
Active Comparator
Arm Description
Gutt systane ultra
Intervention Type
Drug
Intervention Name(s)
Topical Insulin
Other Intervention Name(s)
Gutt insulin
Intervention Description
Insulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks
Primary Outcome Measure Information:
Title
Biochemical marker 1
Description
Interleuikn 1-alpha
Time Frame
4 weeks
Title
Biochemical marker 2
Description
Interleukin 6
Time Frame
4 weeks
Title
Biochemical marker 3
Description
Matrix metallo-proteinase 9
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atikah bt Asini, M.D.
Phone
+60178254335
Email
atikahasini@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mae-Lynn C. Bastion
Organizational Affiliation
PPUKM
Official's Role
Principal Investigator
Facility Information:
Facility Name
PPUKM
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atikah Asini, M.D.
Phone
+60178254335
Email
atikahasini@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

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