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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01552174
Other study ID # MEIBUM survey
Secondary ID
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


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
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