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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189474
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : October 3, 2012
Sponsor:
Information provided by:
Laboratoires Thea

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.


Condition or disease Intervention/treatment Phase
Eyelid Diseases Device: Blephasteam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Intervention Details:
  • Device: Blephasteam
    Eye lid warming goggles



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189474


Locations
Show Show 29 study locations
Sponsors and Collaborators
Laboratoires Thea
Investigators
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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 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

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ClinicalTrials.gov Identifier: NCT01189474    
Other Study ID Numbers: LT2420-PIV-CE-02/10
N° RCB 2010-A00199-30 ( Other Identifier: AFSSAPS )
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by Laboratoires Thea:
Meibomian Gland Dysfunction
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases