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

Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

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.

Study Overview

• Status: Completed
• Conditions: Eyelid Diseases
• Intervention / Treatment: Device: Blephasteam

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU d'Amiens
  • Bordeaux, France, 33000
    • Hopital Pellegrin
  • Dijon, France, 21000
    • CHU de Dijon
  • Hossegord, France, 40150
    • 76 Allée des Pins Tranquilles
  • Le Kremlin Bicêtre, France, 94270
    • CHU de Bicêtre
  • Lille, France, 59000
    • Hopital Claude Huriez
  • Limoges, France, 87042
    • Hôpital Dupuytren
  • Lyon, France, 69000
    • Hôpital Edouard Hériot
  • Marseille, France, 13000
    • 433 bis rue Paradis
  • Marseille, France, 13000
    • Hôpital d'Instruction des Armées Laveran
  • Montferrier sur LEZ, France, 34980
    • 67 chemin du Fescau
  • Montpellier, France, 34000
    • 60 place Jacques Mirouze
  • Nancy, France, 54000
    • 3 cours Leopold
  • Nanterre, France, 92014
    • Hôpital Max Fourestier
  • Nice, France, 06000
    • 4 avenue Baquis
  • Nimes, France, 30029
    • Centre Hospitalier de Nîmes
  • Paris, France, 75012
    • C.H.N.O des XV-XX
  • Paris, France, 75000
    • 22 rue Beaujon
  • Paris, France, 75000
    • Hotel Dieu
  • Paris, France, 75014
    • 142 Boulevard de Montparnasse
  • Paris, France, 75019
    • Fondation Rothschild
  • Puilboreau, France, 17138
    • 26 rue du Moulin des justices
  • Rennes, France, 35000
    • Polyclinique Saint Laurent
  • Saint Etienne, France, 42000
    • CHU de Saint Etienne
  • Strasbourg, France, 67000
    • CHU Hospices Civils
  • Tarbes, France, 65013
    • Hopital de Tarbes
  • Toulouse, France, 31300
    • Clinique du Cours Dillion
  • Tours, France, 37044
    • CHU Bretonneau
  • Vandoeuvre les Nancy, France, 54505
    • Hopital Brabois Adulte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: 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, Centre Hospitalier Universitaire 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 Bicètre; Principal Investigator: Karim LAOUAR, Doctor, Centre Hospitalier de Nîmes; 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

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Meibomian Gland Dysfunction
• Additional Relevant MeSH Terms: Eye Diseases; Meibomian Gland Dysfunction; Eyelid Diseases
• Other Study ID Numbers: LT2420-PIV-CE-02/10; N° RCB 2010-A00199-30 (Other Identifier: AFSSAPS)