Clinical trial NCT01189474: Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases
Official title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelid Diseases
Keywords: Meibomian Gland Dysfunction
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 104
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility criteria: * Signed and dated informed consent.
* Male or female up to 4 years old.
* Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month.
* Without any active pathology requiring a change in ocular treatments within the last month before inclusion.
* Best corrected far visual acuity (VA) \> 1/10

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Dijon
country: France
facility: CHU de Dijon
city: Hossegord
country: France
facility: 76 Allée des Pins Tranquilles
city: Le Kremlin BicÃªtre
country: France
facility: CHU de BicÃªtre
city: Lille
country: France
facility: Hopital Claude Huriez
city: Limoges
country: France
facility: Hopital Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Heriot
city: Marseille
country: France
facility: 433 bis rue Paradis
city: Marseille
country: France
facility: Hopital d'instruction des armées LAVERAN
city: Montferrier sur LEZ
country: France
facility: 67 chemin du Fescau
city: Montpellier
country: France
facility: 60 place Jacques Mirouze
city: Nancy
country: France
facility: 3 cours Leopold
city: Nanterre
country: France
facility: Hopital Max Fourestier
city: Nice
country: France
facility: 4 avenue Baquis
city: Nimes
country: France
facility: Centre Hospitalier de Nimes
city: Paris
country: France
facility: 22 rue Beaujon
city: Paris
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: C.H.N.O des XV-XX
city: Paris
country: France
facility: 142 Boulevard de Montparnasse
city: Paris
country: France
facility: Fondation Rothschild
city: Puilboreau
country: France
facility: 26 rue du Moulin des justices
city: Rennes
country: France
facility: Polyclinique Saint Laurent
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU Hospices Civils
city: Tarbes
country: France
facility: Hôpital de Tarbes
city: Toulouse
country: France
facility: Clinique du Cours Dillion
city: Tours
country: France
facility: CHU Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: Hopital Brabois Adulte
Study officials:
affiliation: Hopital Dupuytren Limoges
name: Jean Paul ADENIS, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Rothschild Paris
name: Isabelle BADELLON, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHNO des quinze-vingts
name: Vincent BORDERIE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Strasbourg
name: Tristan BOURCIER, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu Paris
name: Jean Louis BOURGES, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire, Amiens
name: Dominique BREMOND GIGNAC, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Heriot Lyon
name: Carole BURILLON, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique du cours Dillion
name: Philippe CAZEMIND, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Hervé CHENAL, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Joseph COLIN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Catherine CREUZOT GARCHER, Professor
role: PRINCIPAL_INVESTIGATOR
name: Stephan FAUQUIER, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Denis FLORES, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Saint Etienne
name: Philippe GAIN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Rothschild Paris
name: Olivier Galatoire, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Rothschild Paris
name: Damien GATINEL, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Jean Luc GEORGES, Professor
role: PRINCIPAL_INVESTIGATOR
name: Thanh HOANG XUAN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Polyclinique du Parc
name: Philippe IMBERT, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Bicetre
name: Marc LABETOULLE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Nimes
name: Karim LAOUAR, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de Tarbes
name: Sylvie MAES CASTELLARIN, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Sylvie MAINGUY, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Claire MEURIOT TUIL, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire, Amiens
name: Solange MILAZZO, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bruno MORTEMOUSQUE, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Tours
name: Pierre Jean PISELLA, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Limoges
name: Pierre Yves ROBERT, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Polyclinique Saint Laurent
name: Stephane RONCIN, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Lille
name: Jean François ROULAND, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Lille
name: Pierre LABALETTE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: HIA Laveran
name: Frank ROUX, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Strasbourg
name: Claude SPEEG, ¨Professor
role: PRINCIPAL_INVESTIGATOR
name: Michel TAZARTES, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Yves UTEZA, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Hatem ZEGHIDI, Doctor
role: PRINCIPAL_INVESTIGATOR
name: Benoit BRIAT, Doctor
role: PRINCIPAL_INVESTIGATOR
References: