Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice

Meibomian Gland Dysfunction Clinical Trial

— MEIBUM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552174
• Other study ID #: MEIBUM survey
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: August 31, 2015
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: ZonMw, Netherlands Organisation for Health Research and DevelopmentPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• Ocular Surface Disease
• Palpebral Pathologies

Locations

Country	Name	City	State
Germany	Consultation office	Heidelberg
Spain	USIO Departamento de Oftalmologia Hospital Clínico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoires Thea	Axial Biotech, Inc, IRIS Pharma

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 1	No
Secondary	Association between palpebral pathologies and ocular surface pathologies	To describe association between palpebral pathologies and ocular surface pathologies	Day 1	No
Secondary	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,	Day 1	No
Secondary	Current recommended strategy to treat eyelids disorders	Description of recommended strategy	Day 1	No