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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01091311
First received: March 19, 2010
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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 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, 30 Patients Suffering of Meibomian Glands Dysfunction.

Resource links provided by NLM:

MedlinePlus related topics: Eyelid Disorders
U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Enrollment: 30
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091311

Locations
France
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
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01091311     History of Changes
Other Study ID Numbers: LT2420-PIV-CE-01/10, N° RCB 2010-A00017-32
Study First Received: March 19, 2010
Last Updated: June 7, 2011
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 May 19, 2013