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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014