Meibomian Gland DysfunctionNCT04085016
Effect of HMG-CoA Reductase Inhibitors on the Meibomian Gland Morphology in Patients With Meibomitis
An observational study of Meibomian Gland Dysfunction and Meibomitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study intends to evaluate the relationship between meibomitis and statin use. Meibomitis is the predominant cause of evaporative dry eye. Higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Meibomian Gland Dysfunction, Meibomitis, Dyslipidemias
- What is being tested?
- Keratograph 5M, Oculus, Wetzlar, Germany
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Dec 2016to 31 Jan 2020
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: patients with dyslipidemia
Who may be able to join
- patients with regular HMGCR inhibitor (statin) treatment, and those with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy
Who cannot join
- patients with active eye infection, previous history of chemical or thermal injury to ocular surface, previous operation history of eyelid or conjunctiva, any known allergy or contraindications to statins, history of percutaneous coronary intervention, cerevascular accident, acute coronary syndrome, or rheumatological diseases, fish oil supplements or pregnancy were excluded
Trial locations and contacts
1 site in 1 country.
About this study
This study intends to evaluate the relationship between meibomitis and statin use. Meibomitis is the predominant cause of evaporative dry eye. Higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. We would like to investigate the effect of statin use on meibomitis among patients with dyslipidemia.
Read the detailed description
The purpose of our study is to assess the change of meibomian gland structure in patients during treatment with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors using meibography. Patients with dyslipidemia with or without HMG-CoA reductase inhibitor (statin) treatment were recruited. Medical records are collected prospectively from Dec. 8th 2016 to Dec. 31st 2019. Meibomian gland (MG) morphology described by meiboscores, lid margin abnormality scores, meibum quality, and dry eye parameters were compared between the two groups. This study may also provide information about possible treatment options in patients with meibomitis in the future.
- Conditions
- Meibomian Gland Dysfunction, Meibomitis, Dyslipidemias
- Being tested
- Keratograph 5M, Oculus, Wetzlar, Germany
- Medical subject headings
- Meibomian Gland Dysfunction, Meibomitis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keratograph 5M, Oculus, Wetzlar, GermanyDevice
| Study group | Role | What they receive |
|---|---|---|
| meibography of statin group | patients with regular HMG CoA reductase inhibitor (statin) treatment Receives: Device: Keratograph 5M, Oculus, Wetzlar, Germany | |
| meibography of non-statin group | patients with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy Receives: Device: Keratograph 5M, Oculus, Wetzlar, Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in meiboscore
compare change in meibography images using meiboscore system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start8 Dec 2016
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Jong Wang, MD,PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085016
- Sponsor's protocol ID
- 201610044RINB
- Status last verified
- Oct 2020
- First submitted
- 8 Sep 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinna A, Blasetti F, Zinellu A, Carru C, Solinas G. Meibomian gland dysfunction and hypercholesterolemia. Ophthalmology. 2013 Dec;120(12):2385-2389. doi: 10.1016/j.ophtha.2013.05.002. Epub 2013 Jun 6.
PubMed 23747164Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. doi: 10.1167/iovs.10-6997a. No abstract available.
PubMed 21450913Finis D, Ackermann P, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. Evaluation of Meibomian Gland Dysfunction and Local Distribution of Meibomian Gland Atrophy by Non-contact Infrared Meibography. Curr Eye Res. 2015;40(10):982-9. doi: 10.3109/02713683.2014.971929. Epub 2014 Oct 20.
PubMed 25330304
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HMG-CoA Reductase Inhibitors on the Meibomian Gland Morphology in Patients With Meibomitis
- ClinicalTrials.gov ID
- NCT04085016
- Acronym / sponsor ID
- 201610044RINB
- Conditions
- Meibomian Gland Dysfunction, Meibomitis, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Sep 2019 (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.
This study intends to evaluate the relationship between meibomitis and statin use. Meibomitis is the predominant cause of evaporative dry eye. Higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. We would like to investigate the effect of statin use on meibomitis among patients with dyslipidemia.
Detailed description
The purpose of our study is to assess the change of meibomian gland structure in patients during treatment with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors using meibography. Patients with dyslipidemia with or without HMG-CoA reductase inhibitor (statin) treatment were recruited. Medical records are collected prospectively from Dec. 8th 2016 to Dec. 31st 2019. Meibomian gland (MG) morphology described by meiboscores, lid margin abnormality scores, meibum quality, and dry eye parameters were compared between the two groups. This study may also provide information about possible treatment options in patients with meibomitis in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meibography of statin group | – | Device: Keratograph 5M, Oculus, Wetzlar, Germanypatients with regular HMG CoA reductase inhibitor (statin) treatment |
| meibography of non-statin group | – | Device: Keratograph 5M, Oculus, Wetzlar, Germanypatients with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with dyslipidemia
Key inclusion criteria (1 listed)
- patients with regular HMGCR inhibitor (statin) treatment, and those with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy
Key exclusion criteria (1 listed)
- patients with active eye infection, previous history of chemical or thermal injury to ocular surface, previous operation history of eyelid or conjunctiva, any known allergy or contraindications to statins, history of percutaneous coronary intervention, cerevascular accident, acute coronary syndrome, or rheumatological diseases, fish oil supplements or pregnancy were excluded
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 |
|---|---|---|
| Keratograph 5M, Oculus, Wetzlar, Germany | Device | meibography of non-statin group, meibography of statin group |
Primary outcome
change in meiboscore
Time frame: 6 months
compare change in meibography images using meiboscore system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 23747164Pinna A, Blasetti F, Zinellu A, Carru C, Solinas G. Meibomian gland dysfunction and hypercholesterolemia. Ophthalmology. 2013 Dec;120(12):2385-2389. doi: 10.1016/j.ophtha.2013.05.002. Epub 2013 Jun 6.
- Background: PubMed 21450913Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. doi: 10.1167/iovs.10-6997a. No abstract available.
- Background: PubMed 25330304Finis D, Ackermann P, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. Evaluation of Meibomian Gland Dysfunction and Local Distribution of Meibomian Gland Atrophy by Non-contact Infrared Meibography. Curr Eye Res. 2015;40(10):982-9. doi: 10.3109/02713683.2014.971929. Epub 2014 Oct 20.
- Individual participant dataSharing planned: No
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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.
I-Jong Wang, MD,PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction and Meibomitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 14 Oct 2020. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in meiboscore (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085016, which also lists 3 linked publications.
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 14 Oct 2020.