Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases

NCT01189474 | Completed Phase 4

• 2 other identifiers: LT2420-PIV-CE-02/10N° RCB 2010-A00199-30
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 29

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.

Conditions

Eyelid Diseases

Keywords

Meibomian Gland Dysfunction

Interventions

Blephasteam DEVICE

Eye lid warming goggles

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (29)

CHU d'Amiens

Amiens, 80054, France

Location

Hopital Pellegrin

Bordeaux, 33000, France

Location

CHU de Dijon

Dijon, 21000, France

Location

76 Allée des Pins Tranquilles

Hossegord, 40150, France

Location

CHU de Bicêtre

Le Kremlin Bicêtre, 94270, France

Location

Hopital Claude Huriez

Lille, 59000, France

Location

Hopital Dupuytren

Limoges, 87042, France

Location

Hopital Edouard Heriot

Lyon, 69000, France

Location

433 bis rue Paradis

Marseille, 13000, France

Location

Hopital d'instruction des armées LAVERAN

Marseille, 13000, France

Location

67 chemin du Fescau

Montferrier-sur-Lez, 34980, France

Location

60 place Jacques Mirouze

Montpellier, 34000, France

Location

3 cours Leopold

Nancy, 54000, France

Location

Hopital Max Fourestier

Nanterre, 92014, France

Location

4 avenue Baquis

Nice, 06000, France

Location

Centre Hospitalier de Nimes

Nîmes, 30029, France

Location

22 rue Beaujon

Paris, 75000, France

Location

Hotel Dieu

Paris, 75000, France

Location

C.H.N.O des XV-XX

Paris, 75012, France

Location

142 Boulevard de Montparnasse

Paris, 75014, France

Location

Fondation Rothschild

Paris, 75019, France

Location

26 rue du Moulin des justices

Puilboreau, 17138, France

Location

Polyclinique Saint Laurent

Rennes, 35000, France

Location

CHU de Saint Etienne

Saint-Etienne, 42000, France

Location

CHU Hospices Civils

Strasbourg, 67000, France

Location

Hôpital de Tarbes

Tarbes, 65013, France

Location

Clinique du Cours Dillion

Toulouse, 31300, France

Location

CHU Bretonneau

Tours, 37044, France

Location

Hopital Brabois Adulte

Vandœuvre-lès-Nancy, 54505, France

Location

MeSH Terms

Conditions

Eyelid Diseases; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• 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

  Central Hospital, Nancy, France

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

FR (29)