Effects of Topical Insulin on Levels of Tear Inflammatory... | NCT04877210

Studies
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

NCT04877210

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Status

Unknown status

Last Update Posted

May 11, 2021Actual

Enrollment

60Estimated

Phase

Phase 1

Conditions

Dry Eye

Interventions

Topical Insulin

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2020Actual

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Jan 26, 2022Estimated

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2021

Last Update Posted Date

May 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mae-Lynn Catherine Bastion, Professor Dr, Universiti Kebangsaan Malaysia Medical CentrePrincipal Investigator

Lead Sponsor

Universiti Kebangsaan Malaysia Medical CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Topical Insulin	Drug	Insulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks	Normal Saline Standard Artifical Tear

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Atikah bt Asini, M.D.	Contact	+60178254335		atikahasini@yahoo.com

Overall Officials

Name	Affiliation	Role
Mae-Lynn C. Bastion	PPUKM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PPUKM	Recruiting	Kuala Lumpur			Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided