Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases (ESPOIR Ext)

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01189474
First received: August 25, 2010
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Eyelid Diseases
Device: Blephasteam
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Enrollment: 104
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Blephasteam
    Eye lid warming goggles
  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189474

Locations
France
CHU d'Amiens
Amiens, France, 80054
Hopital Pellegrin
Bordeaux, France, 33000
CHU de Dijon
Dijon, France, 21000
76 Allée des Pins Tranquilles
Hossegord, France, 40150
CHU de Bicêtre
Le Kremlin Bicêtre, France, 94270
Hopital Claude Huriez
Lille, France, 59000
Hopital Dupuytren
Limoges, France, 87042
Hopital Edouard Heriot
Lyon, France, 69000
433 bis rue Paradis
Marseille, France, 13000
Hopital d'instruction des armées LAVERAN
Marseille, France, 13000
67 chemin du Fescau
Montferrier sur LEZ, France, 34980
60 place Jacques Mirouze
Montpellier, France, 34000
3 cours Leopold
Nancy, France, 54000
Hopital Max Fourestier
Nanterre, France, 92014
4 avenue Baquis
Nice, France, 06000
Centre Hospitalier de Nimes
Nimes, France, 30029
22 rue Beaujon
Paris, France, 75000
Hotel Dieu
Paris, France, 75000
Fondation Rothschild
Paris, France, 75019
C.H.N.O des XV-XX
Paris, France, 75012
142 Boulevard de Montparnasse
Paris, France, 75014
26 rue du Moulin des justices
Puilboreau, France, 17138
Polyclinique Saint Laurent
Rennes, France, 35000
CHU de Saint Etienne
Saint Etienne, France, 42000
CHU Hospices Civils
Strasbourg, France, 67000
Hôpital de Tarbes
Tarbes, France, 65013
Clinique du Cours Dillion
Toulouse, France, 31300
CHU Bretonneau
Tours, France, 37044
Hopital Brabois Adulte
Vandoeuvre les Nancy, France, 54505
Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Jean Paul ADENIS, Professor Hopital Dupuytren Limoges
Principal Investigator: Isabelle BADELLON, Doctor Fondation Rothschild Paris
Principal Investigator: Vincent BORDERIE, Professor CHNO des quinze-vingts
Principal Investigator: Tristan BOURCIER, Professor CHU de Strasbourg
Principal Investigator: Jean Louis BOURGES, Doctor Hotel Dieu Paris
Principal Investigator: Dominique BREMOND GIGNAC, Professor Centre Hospitalier Universitaire, Amiens
Principal Investigator: Carole BURILLON, Professor Hopital Edouard Heriot Lyon
Principal Investigator: Philippe CAZEMIND, Doctor Clinique du cours Dillion
Principal Investigator: Hervé CHENAL, Doctor
Principal Investigator: Joseph COLIN, Professor University Hospital, Bordeaux
Principal Investigator: Catherine CREUZOT GARCHER, Professor CHU de Dijon
Principal Investigator: Stephan FAUQUIER, Doctor
Principal Investigator: Denis FLORES, Doctor
Principal Investigator: Philippe GAIN, Professor CHU de Saint Etienne
Principal Investigator: Olivier Galatoire, Doctor Fondation Rothschild Paris
Principal Investigator: Damien GATINEL, Doctor Fondation Rothschild Paris
Principal Investigator: Jean Luc GEORGES, Professor CHU de Nancy
Principal Investigator: Thanh HOANG XUAN, Professor
Principal Investigator: Philippe IMBERT, Doctor Polyclinique du Parc
Principal Investigator: Marc LABETOULLE, Professor CH de Bicetre
Principal Investigator: Karim LAOUAR, Doctor Centre Hospitalier de Nimes
Principal Investigator: Sylvie MAES CASTELLARIN, Doctor Hopital de Tarbes
Principal Investigator: Sylvie MAINGUY, Doctor
Principal Investigator: Claire MEURIOT TUIL, Doctor
Principal Investigator: Solange MILAZZO, Professor Centre Hospitalier Universitaire, Amiens
Principal Investigator: Bruno MORTEMOUSQUE, Doctor University Hospital, Bordeaux
Principal Investigator: Pierre Jean PISELLA, Professor CHU de Tours
Principal Investigator: Pierre Yves ROBERT, Professor University Hospital, Limoges
Principal Investigator: Stephane RONCIN, Doctor Polyclinique Saint Laurent
Principal Investigator: Jean François ROULAND, Professor CHU de Lille
Principal Investigator: Pierre LABALETTE, Professor CHU de Lille
Principal Investigator: Frank ROUX, Doctor HIA Laveran
Principal Investigator: Claude SPEEG, ¨Professor CHU de Strasbourg
Principal Investigator: Michel TAZARTES, Doctor
Principal Investigator: Yves UTEZA, Doctor
Principal Investigator: Hatem ZEGHIDI, Doctor
Principal Investigator: Benoit BRIAT, Doctor
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01189474     History of Changes
Other Study ID Numbers: LT2420-PIV-CE-02/10, N° RCB 2010-A00199-30
Study First Received: August 25, 2010
Last Updated: October 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Thea:
Meibomian Gland Dysfunction

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014