Dry EyePhase 1NCT04877210
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators
A Phase 1 study testing Topical Insulin in people with Dry Eye, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Topical Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Oct 2020to 26 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all diabetics aged 18 - 50 years of age with at least mild OSDI scores
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
PPUKM
Kuala Lumpur
Atikah Asini, M.D., +60178254335, atikahasini@yahoo.com
About this study
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
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
- Conditions
- Dry Eye
- Being tested
- Topical Insulin
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical InsulinDrug
Also called Gutt insulin
Insulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topical Insulin | Experimental | Insulin (Actrapid) diluted in normal saline Receives: Drug: Topical Insulin |
| Normal Saline | Placebo comparator | Normal saline eyedrops Receives: Drug: Topical Insulin |
| Standard Artifical Tear | Active comparator | Gutt systane ultra Receives: Drug: Topical Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical marker 1
Interleuikn 1-alpha
Measured: 4 weeks
Biochemical marker 2
Interleukin 6
Measured: 4 weeks
Biochemical marker 3
Matrix metallo-proteinase 9
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start22 Oct 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion26 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mae-Lynn Catherine Bastion, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Mae-Lynn C. Bastion, Principal investigator, PPUKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877210
- Sponsor's protocol ID
- PPUKM
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04877210
- Acronym / sponsor ID
- PPUKM
- Conditions
- Dry Eye
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 26 Jan 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Insulin | Experimental | Drug: Topical InsulinInsulin (Actrapid) diluted in normal saline |
| Normal Saline | Placebo comparator | Drug: Topical InsulinNormal saline eyedrops |
| Standard Artifical Tear | Active comparator | Drug: Topical InsulinGutt systane ultra |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all diabetics aged 18 - 50 years of age with at least mild OSDI scores
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical InsulinAlso: Gutt insulinInsulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks | Drug | Normal Saline, Standard Artifical Tear, Topical Insulin |
Primary outcome
Biochemical marker 1
Time frame: 4 weeks
Interleuikn 1-alpha
Biochemical marker 2
Time frame: 4 weeks
Interleukin 6
Biochemical marker 3
Time frame: 4 weeks
Matrix metallo-proteinase 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mae-Lynn C. Bastion principal investigator
PPUKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical Insulin in people with Dry Eye, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atikah bt Asini, M.D. (+60178254335, atikahasini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical marker 1 (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.