NCT04877210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 3, 2021

Last Update Submit

May 7, 2021

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (3)

  • Biochemical marker 1

    Interleuikn 1-alpha

    4 weeks

  • Biochemical marker 2

    Interleukin 6

    4 weeks

  • Biochemical marker 3

    Matrix metallo-proteinase 9

    4 weeks

Study Arms (3)

Topical Insulin

EXPERIMENTAL

Insulin (Actrapid) diluted in normal saline

Drug: Topical Insulin

Normal Saline

PLACEBO COMPARATOR

Normal saline eyedrops

Drug: Topical Insulin

Standard Artifical Tear

ACTIVE COMPARATOR

Gutt systane ultra

Drug: Topical Insulin

Interventions

Topical InsulinDRUG

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
Normal SalineStandard Artifical TearTopical Insulin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPUKM

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Insulin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Mae-Lynn C. Bastion

    PPUKM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Atikah bt Asini, M.D.

CONTACT

+60178254335atikahasini@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 7, 2021

Study Start

October 22, 2020

Primary Completion

August 1, 2021

Study Completion

January 26, 2022

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Locations

MY(1)