Palpebral PathologiesMEIBUMNCT01552174
Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice
An observational study of Palpebral Pathologies and Ocular Surface Disease, run by Laboratoires Thea at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palpebral Pathologies, Ocular Surface Disease, Meibomian Gland Dysfunction
- How many people
- 185 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2012to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be eligible for inclusion if all these criteria are respected: * Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation * Patients informed of the objectives of the survey and agreeing to participate. * Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.
Who may be able to join
- Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation
- Patients informed of the objectives of the survey and agreeing to participate.
- Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Spain1 site
USIO Departamento de Oftalmologia Hospital Clínico San Carlos
Madrid, 28040
About this study
The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.
- Keywords
- MGD, ocular surface pathologies
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatients attending general ophthalmologic consultation | * Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation * Patients informed of the objectives of the survey and agreeing to participate. * Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of eyelid disorders in general ophthalmological practice
- Systematic description of the eyelid, the ocular surface and the dermatological aspect of the face
- Occurrence of Meibomian Gland Dysfunction(MGD).
Measured: Day 1
Secondary outcomes (3)
Association between palpebral pathologies and ocular surface pathologies
To describe association between palpebral pathologies and ocular surface pathologies
Measured: Day 1
Impact of eyelid disorder on patient's daily life
Consequences on vision, on daily life activities/work, on leisure, on contact lens wearing, on emotions, on sleeping,
Measured: Day 1
Current recommended strategy to treat eyelids disorders
Description of recommended strategy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palpebral PathologiesStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iris Pharma, Axial Biotech, Inc
- Responsible party
- Sponsor
- Investigators
- José Manuel Benitez del Castillo, Professor, Principal investigator, USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552174
- Sponsor's protocol ID
- MEIBUM survey
- Acronym
- MEIBUM
- Status last verified
- Aug 2015
- First submitted
- 6 Mar 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice
- ClinicalTrials.gov ID
- NCT01552174
- Acronym / sponsor ID
- MEIBUM / MEIBUM survey
- Keywords
- MGD, ocular surface pathologies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Collaborators
- Iris Pharma, Axial Biotech, Inc
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Mar 2012 (estimated)
- 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.
The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients attending general ophthalmologic consultation | – | –* Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation * Patients informed of the objectives of the survey and agreeing to participate. * Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be eligible for inclusion if all these criteria are respected: * Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation * Patients informed of the objectives of the survey and agreeing to participate. * Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.
Key inclusion criteria (3 listed)
- Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation
- Patients informed of the objectives of the survey and agreeing to participate.
- Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of eyelid disorders in general ophthalmological practice
Time frame: Day 1
* Systematic description of the eyelid, the ocular surface and the dermatological aspect of the face * Occurrence of Meibomian Gland Dysfunction(MGD).
3 secondary outcomes
Association between palpebral pathologies and ocular surface pathologies
Time frame: Day 1
Impact of eyelid disorder on patient's daily life
Time frame: Day 1
Current recommended strategy to treat eyelids disorders
Time frame: Day 1
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 1 Sep 2015.
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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.
José Manuel Benitez del Castillo, Professor principal investigator
USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palpebral Pathologies and Ocular Surface Disease, run by Laboratoires Thea at 2 sites in 2 countries.
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 3 inclusion and 0 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 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. 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?
Incidence of eyelid disorders in general ophthalmological practice (time frame: Day 1). 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 1 Sep 2015.