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

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. Identifier: NCT01091311
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : June 8, 2011
Information provided by:
Laboratoires Thea

Brief Summary:

Multicentric study, open label, uncontrolled phase IV in 30 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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 identifier (NCT number): NCT01091311

Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
C.H.N.O des XV-XX
Paris, France, 75012
Hôpital Bichat - Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Laboratoires Thea
Principal Investigator: Christophe Baudouin, Professor Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Principal Investigator: Frédéric Chiambaretta, Professor Centre Hospitalier Universitaire de Clermont Ferrand
Principal Investigator: Serge Doan, Doctor Hopital Bichat Identifier: NCT01091311     History of Changes
Other Study ID Numbers: LT2420-PIV-CE-01/10
N° RCB 2010-A00017-32 ( Other Identifier: AFSSAPS )
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Laboratoires Thea:
Meibomian Gland Dysfunction

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases