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Status unknownNCT04877210Updated May 11, 2021

Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

A Phase 1 interventional study of Topical Insulin in Dry Eye, sponsored by Universiti Kebangsaan Malaysia Medical Centre. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by Universiti Kebangsaan Malaysia Medical Centre · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2020, registered May 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Dry Eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre is the lead sponsor of 57 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • all diabetics aged 18 - 50 years of age with at least mild OSDI scores

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Topical Insulin

    Insulin (Actrapid) diluted in normal saline

    Drug: Topical Insulin

  • Placebo comparator
    Normal Saline

    Normal saline eyedrops

    Drug: Topical Insulin

  • Active comparator
    Standard Artifical Tear

    Gutt systane ultra

    Drug: Topical Insulin

Interventions

  • DrugTopical Insulin

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

    Also known as: Gutt insulin

06

What researchers measure

Primary outcomes

  1. Biochemical marker 1

    Interleuikn 1-alpha

    Time frame: 4 weeks

  2. Biochemical marker 2

    Interleukin 6

    Time frame: 4 weeks

  3. Biochemical marker 3

    Matrix metallo-proteinase 9

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • PPUKM
    Kuala Lumpur, Malaysia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04877210
Lead sponsor
Universiti Kebangsaan Malaysia Medical Centre
Responsible party
Mae-Lynn Catherine Bastion (Professor Dr, Universiti Kebangsaan Malaysia Medical Centre) — Principal investigator
First posted
May 7, 2021
Start date
Oct 22, 2020
Primary completion
Aug 1, 2021 (estimated)
Completion
Jan 26, 2022 (estimated)
Last update
May 11, 2021

Study contacts

Atikah bt Asini, M.D.
Contact
atikahasini@yahoo.com
+60178254335
Mae-Lynn C. Bastion
principal investigator · PPUKM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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